An Examination of a Weight Loss Formula on Health

Weight Loss Clinical Trial

— NB14  

Official title:

An Examination of a Novel Weight Loss Formula on Anthropometry and Indices of Cardiovascular Disease Risk

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03395262
• Other study ID #: IRB2016-0829FX
• Status: Completed
• Phase: N/A
• Start date: June 1, 2017
• Est. completion date: December 31, 2018

Study information

• Verified date: December 2017
• Source: Texas A&M University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to examine a novel weight loss formula with and without common stimulants on anthropometry and indices of cardiovascular disease risk.

Description:

Obesity remains a problem for overall health and risk for cardiovascular disease worldwide. While dietary modification and increased levels of physical activity remain steadfast recommendations, alternative strategies related to supplementation remain an interest for the general populace and medical communities. A potential objection to the use of dietary supplements is that they often contain stimulants designed to increase metabolism. However, consumers and health practitioners alike are wary of such formulae; hence, the continued investigation of non-stimulant supplements is warranted. Therefore the aim of this study is to examine a novel weight loss formula with and without common stimulants on anthropometry and indices of cardiovascular disease risk.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: December 31, 2018
• Est. primary completion date: March 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 45 Years

Eligibility

Inclusion Criteria:

• Body Mass Index (BMI) between 25 and 34.9

Exclusion Criteria:

• Recent history of weight change (+/- 10 lbs. within the past 3 months)

• Uncontrolled metabolic disorders

• Uncontrolled cardiovascular disorders

• Currently taking prescription medications (birth control is allowed)

• Currently taking dietary supplements for weight loss

• Pregnant or plan to become pregnant

• Have an intolerance to caffeine or other natural stimulants

Related Conditions & MeSH terms

• Body Weight
• Weight Loss

Intervention

Dietary Supplement:
• Active with caffeine
Novel formula with caffeine
• Active without caffeine
Novel formula without caffeine
• Placebo
Dextrose placebo

Locations

Country	Name	City	State
United States	Exercise & Sport Nutrition Lab - Human Clinical Research Facility	College Station	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Texas A&M University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body Composition - Weight	Changes in body weight (kg) analyzed with related body composition variables via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).	Measured every 4 weeks for 12 weeks
Primary	Body Composition - Fat Mass	Changes in fat mass (kg) analyzed with related body composition variables via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).	Measured every 4 weeks for 12 weeks
Primary	Body Composition - Body Fat Percent	Changes in body fat (%) analyzed with related body composition variables via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).	Measured every 4 weeks for 12 weeks
Secondary	Body Composition - Lean Tissue Mass	Change in lean tissue mass (kg) analyzed with related body composition outcome measures via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).	Measured every 4 weeks for 12 weeks
Secondary	Body Composition - Bone Mass	Change in bone mass (g) analyzed with related body composition outcome measures via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).	Measured every 4 weeks for 12 weeks
Secondary	Body Composition - Fat Free Mass	Changes in fat free mass (sum of lean tissue mass and bone mass expressed in kg) analyzed with related body composition variables via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).	Measured every 4 weeks for 12 weeks
Secondary	Body Composition - Total Body Water	Change in total body water (L and %) and analyzed with related body composition outcome measures via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).	Measured every 4 weeks for 12 weeks
Secondary	Resting Energy Expenditure - Caloric Expenditure	Change in resting energy expenditure expressed in absolute (kcals/d) and relative terms (kcals/kg/day) and analyzed with related resting energy expenditure outcome measures via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).	Measured every 4 weeks for 12 weeks
Secondary	Resting Energy Expenditure - Respiratory Exchange Ratio	Change in resting respiratory exchange ratio (RER) as an indicator of carbohydrate and fat oxidation analyzed with related resting energy expenditure outcome measures via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).	Measured every 4 weeks for 12 weeks
Secondary	Anthropometric Measures - Waist Circumference	Change in waist circumference (cm) analyzed with related anthropometric outcome measures via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).	Measured every 4 weeks for 12 weeks
Secondary	Anthropometric Measures - Hip Circumference	Change in hip circumference (cm) analyzed with related anthropometric outcome measures via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).	Measured every 4 weeks for 12 weeks
Secondary	Anthropometric Measures - Waist to Hip Ratio	Change in the ratio of waist to hip (waist / hip circumference) analyzed with related anthropometric outcome measures via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).	Measured every 4 weeks for 12 weeks
Secondary	Anthropometric Measures - Body Mass Index	Change in body mass index (kg of body mass / height in meters squared) analyzed with related anthropometric outcome measures via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).	Measured every 4 weeks for 12 weeks
Secondary	Dietary Energy Intake - Total Caloric Intake	Change in caloric/energy intake (kcals/day) analyzed with related energy intake outcome measures via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).	Measured every 4 weeks for 12 weeks
Secondary	Dietary Energy Intake - Carbohydrate	Change in dietary carbohydrate intake (grams/day and grams/kg/day) analyzed with related energy intake outcome measures via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).	Measured every 4 weeks for 12 weeks
Secondary	Dietary Energy Intake - Fat	Change in dietary fat intake (grams/day and grams/kg/day) analyzed with related energy intake outcome measures via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).	Measured every 4 weeks for 12 weeks
Secondary	Dietary Energy Intake - Protein	Change in dietary protein intake (grams/day and grams/kg/day) analyzed with related energy intake outcome measures via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).	Measured every 4 weeks for 12 weeks
Secondary	Resting Hemodynamics - Heart Rate	Changes in resting heart rate (bpm) analyzed with related resting hemodynamic outcome measures via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).	Measured every 4 weeks for 12 weeks
Secondary	Resting Hemodynamics - Systolic Blood Pressure	Changes in resting systolic blood pressure (mmHg) analyzed with related resting hemodynamic outcome measures via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).	Measured every 4 weeks for 12 weeks
Secondary	Resting Hemodynamics - Diastolic Blood Pressure	Changes in resting diastolic blood pressure (mmHg) analyzed with related resting hemodynamic outcome measures via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).	Measured every 4 weeks for 12 weeks
Secondary	Blood Chemistry Markers of Health - Glucose Homeostasis - Blood Glucose	Change in blood glucose (mg/dl) analyzed with related glucose homeostasis blood chemistry markers of health via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).	Measured every 4 weeks for 12 weeks
Secondary	Blood Chemistry Markers of Health - Glucose Homeostasis - Fasting Insulin	Change in fasting insulin (µIU/mL) analyzed with related glucose homeostasis blood chemistry markers of health via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).	Measured every 4 weeks for 12 weeks
Secondary	Blood Chemistry Markers of Health - Glucose Homeostasis - Homeostatic Model Assessment of Insulin Resistance	Change in Homeostatic Model Assessment of Insulin Resistance (Fasting insulin x Fasting glucose / 405) analyzed with related glucose homeostasis blood chemistry markers of health via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).	Measured every 4 weeks for 12 weeks
Secondary	Blood Chemistry Markers of Health - Lipid Profile - Triglyderides	Change in triglycerides (mg/dl) analyzed with related lipid profile blood chemistry markers of health via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).	Measured every 4 weeks for 12 weeks
Secondary	Blood Chemistry Markers of Health - Lipid Profile - Total Cholesterol	Change in total cholesterol (mg/dl) analyzed with related lipid profile blood chemistry markers of health via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).	Measured every 4 weeks for 12 weeks
Secondary	Blood Chemistry Markers of Health - Lipid Profile - High Density Lipoproteins	Change in high density lipoproteins (mg/dl) analyzed with related lipid profile blood chemistry markers of health via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).	Measured every 4 weeks for 12 weeks
Secondary	Blood Chemistry Markers of Health - Lipid Profile - Low Density Lipoproteins	Change in low density lipoproteins (mg/dl) analyzed with related lipid profile blood chemistry markers of health via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).	Measured every 4 weeks for 12 weeks
Secondary	Blood Chemistry Markers of Health - Lipid Profile - Total Cholesterol to HDL Ratio	Change in the ratio of total cholesterol to high density lipoproteins (HDL) analyzed with related lipid profile blood chemistry markers of health via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).	Measured every 4 weeks for 12 weeks
Secondary	Blood Chemistry Markers of Health - Catabolic Markers - Creatinine	Change in creatinine (mg/dl) analyzed with related blood chemistry catabolic markers of health via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).	Measured every 4 weeks for 12 weeks
Secondary	Blood Chemistry Markers of Health - Catabolic Markers - Blood Urea Nitrogen	Change in blood urea nitrogen (mg/dl) analyzed with related blood chemistry catabolic markers of health via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).	Measured every 4 weeks for 12 weeks
Secondary	Blood Chemistry Markers of Health - Catabolic Markers - Blood Urea Nitrogen to Creatinine Ratio	Change in the ratio of blood urea nitrogen (mg/dl) to creatinine (mg/dl) analyzed with related blood chemistry catabolic markers of health via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).	Measured every 4 weeks for 12 weeks
Secondary	Blood Chemistry Markers of Health - Catabolic Markers - Alkaline Phosphatase	Change in alkaline phosphatase (IU/L) analyzed with related blood chemistry catabolic markers of health via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).	Measured every 4 weeks for 12 weeks
Secondary	Blood Chemistry Markers of Health - Catabolic Markers - Alanine Amino Transaminase	Change in alanine amino transaminase (IU/L) analyzed with related blood chemistry catabolic markers of health via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).	Measured every 4 weeks for 12 weeks
Secondary	Blood Chemistry Markers of Health - Catabolic Markers - Aspartate Amino Transaminase	Change in aspartate amino transaminase (IU/L) analyzed with related blood chemistry catabolic markers of health via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).	Measured every 4 weeks for 12 weeks
Secondary	Blood Chemistry Markers of Health - Catabolic Markers - Creatine Kinase	Change in creatine kinase (IU/L) analyzed with related blood chemistry catabolic markers of health via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).	Measured every 4 weeks for 12 weeks
Secondary	Blood Chemistry Markers of Health - Catabolic Markers - Lactate Dehydrogenase	Change in lactate dehydrogenase (IU/L) analyzed with related blood chemistry catabolic markers of health via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).	Measured every 4 weeks for 12 weeks
Secondary	Blood Chemistry Markers of Health - White Blood Cell Counts - White Blood Cells	Change in white blood cells (K/uL) analyzed with related white blood cell count markers of health via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).	Measured every 4 weeks for 12 weeks
Secondary	Blood Chemistry Markers of Health - White Blood Cell Counts - Lymphocytes	Change in lymphocytes (K/uL) analyzed with related white blood cell count markers of health via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).	Measured every 4 weeks for 12 weeks
Secondary	Blood Chemistry Markers of Health - White Blood Cell Counts - Mid-Range Count	Change in mid-range count (K/uL) analyzed with related white blood cell count markers of health via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).	Measured every 4 weeks for 12 weeks
Secondary	Blood Chemistry Markers of Health - White Blood Cell Counts - Granulocyte	Change in granulocyte count (K/uL) analyzed with related white blood cell count markers of health via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).	Measured every 4 weeks for 12 weeks
Secondary	Blood Chemistry Markers of Health - Red Blood Cell Counts - Red Cells	Change in red cell count (M/uL) analyzed with related red blood cell count markers of health via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).	Measured every 4 weeks for 12 weeks
Secondary	Blood Chemistry Markers of Health - Red Blood Cell Counts - Hemoglobin	Change in hemoglobin (g/dl) analyzed with related red blood cell count markers of health via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).	Measured every 4 weeks for 12 weeks
Secondary	Blood Chemistry Markers of Health - Red Blood Cell Counts - Hematocrit	Change in hematocrit (%) analyzed with related red blood cell count markers of health via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).	Measured every 4 weeks for 12 weeks
Secondary	Blood Chemistry Markers of Health - Red Blood Cell Counts - Mean Corpuscular Volume	Change in mean corpuscular volume (fL) analyzed with related red blood cell count markers of health via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).	Measured every 4 weeks for 12 weeks
Secondary	Blood Chemistry Markers of Health - Red Blood Cell Counts - Mean Corpuscular Hemoglobin	Change in mean corpuscular hemoglobin (pg/cell) analyzed with related red blood cell count markers of health via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).	Measured every 4 weeks for 12 weeks
Secondary	Blood Chemistry Markers of Health - Red Blood Cell Counts - Mean Corpuscular Hemoglobin Concentration	Change in mean corpuscular hemoglobin concentration (g/dl) analyzed with related red blood cell count markers of health via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).	Measured every 4 weeks for 12 weeks
Secondary	Blood Chemistry Markers of Health - Red Blood Cell Counts - Red Cell Distribution Width	Change in red cell distribution width (%) analyzed with related red blood cell count markers of health via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).	Measured every 4 weeks for 12 weeks
Secondary	Blood Chemistry Markers of Health - Red Blood Cell Counts - Platelet Count	Change in platelet count (x103/uL) analyzed with related red blood cell count markers of health via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).	Measured every 4 weeks for 12 weeks
Secondary	Blood Chemistry Markers of Health - Red Blood Cell Counts - Mean Platelet Volume	Change in mean platelet volume (fL) analyzed with related red blood cell count markers of health via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).	Measured every 4 weeks for 12 weeks
Secondary	Blood Chemistry Markers of Health - Appetite Hormone - Leptin	Change in leptin levels (ng/ml) analyzed via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).	Measured every 4 weeks for 12 weeks
Secondary	International Physical Activity Questionnaire (IPAQ) - Work Domain	Change in IPAQ work domain (MET minutes/week) analyzed with related IPAQ outcome measures via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).	Measured every 4 weeks for 12 weeks
Secondary	International Physical Activity Questionnaire (IPAQ) - Active Transportation Domain	Change in IPAQ active transportation domain (MET minutes/week) analyzed with related IPAQ outcome measures via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).	Measured every 4 weeks for 12 weeks
Secondary	International Physical Activity Questionnaire (IPAQ) - Domestic and Garden/Yard Work Domain	Change in IPAQ domestic and garden/yard work domain (MET minutes/week) analyzed with related IPAQ outcome measures via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).	Measured every 4 weeks for 12 weeks
Secondary	International Physical Activity Questionnaire (IPAQ) - Leisure-Time Domain	Change in IPAQ leisure-time domain (MET minutes/week) analyzed with related IPAQ outcome measures via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).	Measured every 4 weeks for 12 weeks
Secondary	International Physical Activity Questionnaire (IPAQ) - Total Physical Activity Score	Change in IPAQ leisure time domain (Total physical activity MET-minutes/week = sum of Total Work + Total Transport + Total Domestic and Garden + Total Leisure-Time MET-minutes/week scores) analyzed with related IPAQ outcome measures via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).	Measured every 4 weeks for 12 weeks
Secondary	Satiety Questionnaire - Perceptions of Appetite	Changes in perceptions of appetite assessed using using a 0 to 10 Likert scale (0 was none, 2.5 was low, 5 was moderate, and 7.5 was high, and 10 was severe) and analyzed with related satiety questionnaire outcomes via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).	Measured every 4 weeks for 12 weeks
Secondary	Satiety Questionnaire - Perceptions of Hunger	Changes in perceptions of hunger assessed using using a 0 to 10 Likert scale (0 was none, 2.5 was low, 5 was moderate, and 7.5 was high, and 10 was severe) and analyzed with related satiety questionnaire outcomes via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).	Measured every 4 weeks for 12 weeks
Secondary	Satiety Questionnaire - Perceptions of Satisfaction with Food	Changes in perceptions of satisfaction with food assessed using using a 0 to 10 Likert scale (0 was none, 2.5 was low, 5 was moderate, and 7.5 was high, and 10 was severe) and analyzed with related satiety questionnaire outcomes via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).	Measured every 4 weeks for 12 weeks
Secondary	Satiety Questionnaire - Perceptions of Feelings of Fullness	Changes in perceptions of feelings of fullness assessed using using a 0 to 10 Likert scale (0 was none, 2.5 was low, 5 was moderate, and 7.5 was high, and 10 was severe) and analyzed with related satiety questionnaire outcomes via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).	Measured every 4 weeks for 12 weeks
Secondary	Satiety Questionnaire - Perceptions of Diet / Eating Satisfaction	Changes in perceptions of diet / eating satisfaction assessed using using a 0 to 10 Likert scale (0 was none, 2.5 was low, 5 was moderate, and 7.5 was high, and 10 was severe) and analyzed with related satiety questionnaire outcomes via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).	Measured every 4 weeks for 12 weeks
Secondary	Sleep Quality Questionnaire - Sleep Duration	Changes in average reported sleep duration over the prior 48 hours analyzed with related sleep quality questionnaire outcomes via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).	Measured every 4 weeks for 12 weeks
Secondary	Sleep Quality Questionnaire - Sleep Quality	Changes in rating of sleep quality over the prior 48 hours analyzed with related sleep quality questionnaire outcomes via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).	Measured every 4 weeks for 12 weeks
Secondary	Sleep Quality Questionnaire - Enthusiasm	Changes in rating of enthusiasm over the prior 48 hours analyzed with related sleep quality questionnaire outcomes via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).	Measured every 4 weeks for 12 weeks
Secondary	Sleep Quality Questionnaire - Sleep Disturbances	Changes in rating of sleep disturbances over the prior 48 hours analyzed with related sleep quality questionnaire outcomes via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).	Measured every 4 weeks for 12 weeks
Secondary	Perceptions of Side Effects - Dizziness	Change in perceptions of dizziness using a Likert scale [0 (none), 1-4 (light), 5-6 (mild), 7-9 (severe), or 10 (very severe)] and analyzed with related side effect outcome measures via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).	Measured every 4 weeks for 12 weeks
Secondary	Perceptions of Side Effects - Headache	Change in perceptions of headache using a Likert scale [0 (none), 1-4 (light), 5-6 (mild), 7-9 (severe), or 10 (very severe)] and analyzed with related side effect outcome measures via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).	Measured every 4 weeks for 12 weeks
Secondary	Perceptions of Side Effects - Tachycardia	Change in perceptions of tachycardia using a Likert scale [0 (none), 1-4 (light), 5-6 (mild), 7-9 (severe), or 10 (very severe)] and analyzed with related side effect outcome measures via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).	Measured every 4 weeks for 12 weeks
Secondary	Perceptions of Side Effects - Palpitations	Change in perceptions of palpitations using a Likert scale [0 (none), 1-4 (light), 5-6 (mild), 7-9 (severe), or 10 (very severe)] and analyzed with related side effect outcome measures via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).	Measured every 4 weeks for 12 weeks
Secondary	Perceptions of Side Effects - Dyspnea	Change in perceptions of dyspnea using a Likert scale [0 (none), 1-4 (light), 5-6 (mild), 7-9 (severe), or 10 (very severe)] and analyzed with related side effect outcome measures via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).	Measured every 4 weeks for 12 weeks
Secondary	Perceptions of Side Effects - Nervousness	Change in perceptions of nervousness using a Likert scale [0 (none), 1-4 (light), 5-6 (mild), 7-9 (severe), or 10 (very severe)] and analyzed with related side effect outcome measures via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).	Measured every 4 weeks for 12 weeks
Secondary	Perceptions of Side Effects - Blurred Vision	Change in perceptions of blurred vision using a Likert scale [0 (none), 1-4 (light), 5-6 (mild), 7-9 (severe), or 10 (very severe)] and analyzed with related side effect outcome measures via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).	Measured every 4 weeks for 12 weeks
Secondary	Perceptions of Side Effects - Other Side Effects	Change in perceptions of other side effects using a Likert scale [0 (none), 1-4 (light), 5-6 (mild), 7-9 (severe), or 10 (very severe)] and analyzed with related side effect outcome measures via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).	Measured every 4 weeks for 12 weeks