Effects of Diet Manipulation on Women in the Curves Program

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

Official Title
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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

Conditions
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Diet, Carbohydrate-Restricted

Intervention / Treatment
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* Other: Control
* Other: American Heart Association plus exercise
* Other: Curves Complete - I plus exercise
* Other: Curves Complete - II plus exercise


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | Measure Description | 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 |