Effects of Diet Manipulation on Women in the Curves Program

Diet, Carbohydrate-Restricted Clinical Trial

— Curves2  

Official title:

Effects of a Carbohydrate Restricted, High Protein, High Fat Diet on Weight Loss and Health Outcomes in Women Participating in the Curves Fitness and Weight Loss Program

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03093792
• Other study ID #: IRB2013-0495FX
• Status: Completed
• Phase: N/A
• First received: March 22, 2017
• Last updated: March 22, 2017
• Start date: September 1, 2013
• Est. completion date: May 1, 2015

Study information

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

Clinical Trial Summary

The purpose of this study is to look at the effects of a carbohydrate restricted, high protein, high fat diet on weight loss and health outcomes in women participating in the Curves Fitness and Weight Loss Program.

Description:

The purpose of this study is to determine if a carbohydrate restricted, high protein, high fat diet (20% carbohydrate, 45% protein, 35% fat; CC-II) promotes more favorable changes in weight loss and health outcomes compared to a traditional high carbohydrate, low protein, low fat diet (55% carbohydrate, 15% protein, 30% fat; AHA) and the Curves moderate carbohydrate restricted, high protein, and low fat diet (30% carbohydrate, 45% protein, 25% fat; CC-I).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: May 1, 2015
• Est. primary completion date: May 1, 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• The participant is an apparently healthy female

• The participant is between the ages of 18 and 60

Exclusion Criteria:

• The participant is pregnant or nursing, or plans to become pregnant during the next 12 months or has been pregnant in the past 12 months

• The participant has uncontrolled metabolic disorder including known electrolyte abnormalities; heart disease, arrhythmias, diabetes, thyroid disease, or hypogonadism; a history of hypertension, hepatorenal, musculoskeletal, autoimmune, or neurological disease

• The participant is currently taking thyroid, hyperlipidemic, hypoglycemic, anti-hypertensive, or androgenic medications

• The participant has taken ergogenic levels of nutritional supplements that may affect muscle mass (e.g., creatine, HMB), anabolic/catabolic hormone levels (androstenedione, DHEA, etc.) or weight loss (e.g., ephedra, thermogenics, etc.) within the past three months

• The participant is willing to participate in a regular moderate exercise program

Related Conditions & MeSH terms

• Diet, Carbohydrate-Restricted

Intervention

Other:
• Control

• American Heart Association plus exercise

• Curves Complete - I plus exercise

• Curves Complete - II plus exercise

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Texas A&M University	Curves International

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effects of the Curves program on physical activity patterns		24 weeks
Primary	Effects of the Curves program on body weight		24 weeks
Primary	Effects of the Curves program on the hip/waist ratio		24 weeks
Primary	Effects of the Curves program on Resting Energy Expenditure (REE)		24 weeks
Primary	Effects of the Curves program on Blood Pressure (BP)		24 weeks
Primary	Effects of the Curves program on Heart Rate (HR)		24 weeks
Primary	Effects of the Curves program on body composition (DXA)		24 weeks
Primary	Effects of the Curves program on Bioelectrical Impedance Analysis (BIA)		24 weeks
Primary	Effects of the Curves program on a chemistry-15 blood panel		24 weeks
Primary	Effects of the Curves program on a cell blood count (CBC) blood panel		24 weeks
Primary	Effects of the Curves program on lipid panels		24 weeks
Secondary	Effects of the Curves program on maximal cardiopulmonary capacity		24 weeks
Secondary	Effects of the Curves program on muscular strength through a 1 repetition maximum (1 RM) test		24 weeks
Secondary	Effects of the Curves program on muscular endurance through a maximal repetition test		24 weeks