Effects of Diet Manipulation on Women in the Curves Program (Curves2)

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

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.

Study Overview

• Status: Completed
• Conditions: Diet, Carbohydrate-Restricted
• Intervention / Treatment: Other: Control; Other: American Heart Association plus exercise; Other: Curves Complete - I plus exercise; Other: Curves Complete - II plus exercise

Detailed 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).

• Study Type: Interventional
• Enrollment (Actual): 86
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Control; (no diet or exercise intervention)	Other: Control
Experimental: American Heart Association; (AHA: 55% carbohydrate, 15% protein, 30% fat - diet plus exercise)	Other: American Heart Association plus exercise
Active Comparator: Curves Complete - I; (CC - I: 30% carbohydrate, 45% protein, 25% fat - diet plus exercise)	Other: Curves Complete - I plus exercise
Active Comparator: Curves Complete - II; (CC - II: 20% carbohydrate, 45% protein, 35% fat - diet plus exercise)	Other: Curves Complete - II plus exercise

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Effects of the Curves program on physical activity patterns	24 weeks
Effects of the Curves program on body weight	24 weeks
Effects of the Curves program on the hip/waist ratio	24 weeks
Effects of the Curves program on Resting Energy Expenditure (REE)	24 weeks
Effects of the Curves program on Blood Pressure (BP)	24 weeks
Effects of the Curves program on Heart Rate (HR)	24 weeks
Effects of the Curves program on body composition (DXA)	24 weeks
Effects of the Curves program on Bioelectrical Impedance Analysis (BIA)	24 weeks
Effects of the Curves program on a chemistry-15 blood panel	24 weeks
Effects of the Curves program on a cell blood count (CBC) blood panel	24 weeks
Effects of the Curves program on lipid panels	24 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Effects of the Curves program on maximal cardiopulmonary capacity	24 weeks
Effects of the Curves program on muscular strength through a 1 repetition maximum (1 RM) test	24 weeks
Effects of the Curves program on muscular endurance through a maximal repetition test	24 weeks

Collaborators and Investigators

• Sponsor: Texas A&M University
• Collaborators: Curves International
• Investigators: Principal Investigator: Richard B Kreider, PhD, Texas A&M University

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2013
• Primary Completion (Actual): May 1, 2015
• Study Completion (Actual): May 1, 2015

Study Registration Dates

• First Submitted: March 22, 2017
• First Submitted That Met QC Criteria: March 22, 2017
• First Posted (Actual): March 28, 2017

Study Record Updates

• Last Update Posted (Actual): March 28, 2017
• Last Update Submitted That Met QC Criteria: March 22, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: IRB2013-0495FX

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No