A Comparative Effectiveness Study Evaluating the Effects of Thermogenic Supplements on Body Composition

Weight Loss Clinical Trial

Official title:

A Comparative Effectiveness Study Evaluating the Effects of Two Thermogenic Supplements on Body Composition Using a Double-Blinded Placebo-Controlled Protocol

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01423019
• Other study ID #: Nutratech - 60
• Status: Completed
• Phase: N/A
• First received: July 5, 2011
• Last updated: January 20, 2012
• Start date: October 2011
• Est. completion date: January 2012

Study information

• Verified date: January 2012
• Source: Integrative Health Technologies, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether subjects taking a supplement designed to increase metabolic rate will have a positive effect on body composition (fat mass, muscle mass, and bone density.)

Description:

In a previous randomized double-blinded placebo-controlled pilot study, subjects taking the nutritional supplements contained in these two weight loss plans had a short-term statistically significant increase in their resting metabolic rates as compared to taking a placebo. No increases were found in blood pressure, resting heart rate, or self-reported discomfort when taking the supplement.

The current study was designed to extend the findings of the pilot study over a 60-day study period using a randomized double-blinded placebo-controlled protocol with the same weight loss interventions.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

• Must ensure with medical provider that there are no medical conditions that would preclude participation

• Must be able to swallow capsules

• Must be age 21 or above

Exclusion Criteria:

• Pregnant or breast feeding

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator)

Related Conditions & MeSH terms

• Weight Loss

Intervention

Dietary Supplement:
• Advantra Z
Two capsules are taken twice daily, 20-30 minutes before breakfast and evening meals. Two capsules contain a total of 50 mg p-synephrine.
• Advantra Z + Naringin + Hesperiden
Two capsules are taken twice daily, 20-30 minutes before breakfast and evening meals. Two capsules contain a total of 50 mg p-synephrine, 600 mg naringin, and 100 mg hesperiden.

Other:
• Sugar pill
Two capsules containing inert ingredients are taken twice daily, 20-30 minutes before breakfast and evening meals.

Locations

Country	Name	City	State
United States	Integrative Health Technologies, Inc.	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Integrative Health Technologies, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (1)

Stohs SJ, Preuss HG, Keith SC, Keith PL, Miller H, Kaats GR. Effects of p-synephrine alone and in combination with selected bioflavonoids on resting metabolism, blood pressure, heart rate and self-reported mood changes. Int J Med Sci. 2011 Apr 28;8(4):295-301. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body Composition (fat, fat-free mass and bone mineral density) as measured by Dual Energy X-ray Absorptiometry (DXA)	This study goes beyond assessing changes in scale weight and BMI. DXA is used to assess changes in body composition (lean, fat and bone) associated with the weight loss interventions.	0 and 60 days	No
Secondary	43-item blood chemistry panel	43 chemistries including Lipids, CBC, Metabolic panel, TSH, and Cardio CrP	0 and 60 days	Yes
Secondary	Change from Baseline in Systolic and Diastolic Blood Pressure at 30 days	Measures the amount of force (pressure) that blood exerts on the walls of the blood vessels as it passes through them. Systolic blood pressure is a measure of blood pressure while the heart is beating. Diastolic pressure is a measure of blood pressure while the heart is relaxed, between heartbeats. Measurements will be taken after sitting or lying down for at least 5 minutes. Changes will be reported between baseline and day 30 of study.	0 and 30 days	Yes
Secondary	Change from Baseline in Resting Heart Rate at 30 days	Measure of heart rate after sitting or lying down for at least 5 minutes. Changes will be reported between baseline and day 30 of study.	0 and 30 days	Yes
Secondary	Change from midpoint of study in Resting Heart Rate at 60 days	Measure of heart rate after sitting or lying down for at least 5 minutes. Changes will be reported between day 30 and 60 of study.	30 and 60 days	Yes
Secondary	Change from Baseline in Systolic and Diastolic Blood Pressure at 60 days	Measures the amount of force (pressure) that blood exerts on the walls of the blood vessels as it passes through them. Systolic blood pressure is a measure of blood pressure while the heart is beating. Diastolic pressure is a measure of blood pressure while the heart is relaxed, between heartbeats. Measurements will be taken after sitting or lying down for at least 5 minutes. Changes will be reported between baseline and day 60 of study.	0 and 60 days	Yes
Secondary	Change from Baseline in Resting Heart Rate at 60 days	Measure of heart rate after sitting or lying down for at least 5 minutes. Changes will be reported between baseline and day 60 of study.	0 and 60 days	Yes
Secondary	Change from Baseline in self-reported quality of life at 30 days.		0 and 30 days	Yes
Secondary	Change from mid-point of study in self-reported quality of life at 60 days.		30 and 60 days	Yes
Secondary	Change from Baseline in self-reported quality of life at 60 days.		0 and 60 days	Yes
Secondary	Change from Baseline in self-reported eating behavior at 30 days.	A subscale of the 86-item quality of life inventory assessing 15 items related to the subjects' ability to control eating behavior	0 and 30 days	No
Secondary	Change from mid-point of study in self-reported eating behavior at 60 days	A subscale of the 86-item quality of life inventory assessing 15 items related to the subjects' ability to control eating behavior	30 and 60 days	No
Secondary	Change from Baseline in self-reported eating behavior at 60 days.	A subscale of the 86-item quality of life inventory assessing 15 items related to the subjects' ability to control eating behavior	0 and 60 days	No
Secondary	Change from mid-point of study in Systolic and Diastolic Blood Pressure at 60 days	Measures the amount of force (pressure) that blood exerts on the walls of the blood vessels as it passes through them. Systolic blood pressure is a measure of blood pressure while the heart is beating. Diastolic pressure is a measure of blood pressure while the heart is relaxed, between heartbeats. Measurements will be taken after sitting or lying down for at least 5 minutes. Changes will be reported between mid-point and day 60 of study.	30 and 60 days	Yes
Secondary	Number of participants with adverse events	Participants will have opportunity to report on a daily basis any adverse events experienced.	up to 60 days	Yes

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