Curves 30/30 Study

Study Overview
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Brief Summary
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The purpose of this study is to determine whether following a high carbohydrate/low fat diet or high protein/low fat diet for 30-days several times during six months of participating in the Curves fitness and diet program with or without dietary calcium supplementation promotes stepwise reductions in body weight, improvements in body composition, and/or improvements in markers of fitness and health.

Detailed Description
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The Curves International fitness and weight loss program has become a very popular means of promoting health and fitness among women. The program involves a 30-minute circuit training program and a weight management program involving periods of moderate caloric restriction (1,200 to 1,600 calories per day) followed by short periods of higher caloric intake (2,600 calories per day). The program is designed to promote a gradual reduction in body fat while increasing strength and muscle mass/tone. Researchers in the Exercise & Sport Nutrition Laboratory (ESNL) at Texas A&M University have conducted an extensive study on the effectiveness and safety of the Curves fitness and diet program. Results of this initial study have shown that the program promotes weight loss, improves markers of health, and improves fitness. However, we feel that the program may be even more effective with some additional nutritional interventions. Calcium has been shown to slow bone loss and more recently has been found to help promote fat loss. If this is the case, supplementing the diet with calcium may promote greater benefits in women participating in the Curves fitness and diet program. The purpose of this study is to determine whether following a high carbohydrate/low fat diet or high protein/low fat diet for 30-days several times during six months of participating in the Curves fitness and diet program with or without dietary calcium supplementation promotes stepwise reductions in body weight, improvements in body composition, and/or improvements in markers of fitness and health.

Official Title
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Effects of Repeated Short-Term Diets on Weight Loss in Women Participating in the Curves Fitness Program

Conditions
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Weight Loss

Intervention / Treatment
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* Dietary Supplement: Curves Calcium
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participant is female; Participant is post-menopausal; Participant is between the ages of 18 and 45; Participant is sedentary, overweight (BMI > 27) and post-menopausal; Exclusion Criteria: Participant has any metabolic disorders including known electrolyte abnormalities, heart disease, arrhythmias, diabetes, or thyroid disease; Participant has a history of hypertension, hepatorenal, musculoskeletal, autoimmune or neurological disease; Participant is taking thyroid, hyperlipidemic, hypoglycemic, anti-hypertensive or androgenic medications; Participant has taken ergogenic levels of nutritional supplements that may affect muscle mass (i.e., creatine, HMB, etc.), anabolic/catabolic hormone levels (i.e., androstenedione, DHEA, etc.) or weight loss (i.e., ephedra, thermogenics, etc.) within three months prior to the start of the study; Participant is consistently taking 500 mg or more of a Calcium supplement per day; Participant is receiving Hormone Replacement Therapy (HRT); Participant is involved in a planned exercise program within 3 - 6 months prior to the start of the study; Participant has lost > 20 lbs. within the last 3 - 6 months;

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 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
Interventional Model Description: Randomized, placebo controlled, repeated measures intervention trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control<br>No diet or exercise intervention | Dietary Supplement: Curves Calcium<br>* Dietary Supplement: Curves Calcium Curves Essential Bio-Available Calcium (providing 800 mg/d of calcium [as calcium citrate malate and calcium citrate], 400 IU of Vitamin D, 300 mg/d of magnesium, 4 mg/d of zinc, 2 mg/d of copper, 2 mg/d of manganese, 198 mg/d of potassium, 100 mg/d of trace mineral complex, and 2 mg/d of boron)<br>Dietary Supplement: Placebo<br>* Dextrose Placebo<br>|
| Experimental: No Diet plus Exercise<br>No diet, exercise only intervention | Dietary Supplement: Curves Calcium<br>* Dietary Supplement: Curves Calcium Curves Essential Bio-Available Calcium (providing 800 mg/d of calcium [as calcium citrate malate and calcium citrate], 400 IU of Vitamin D, 300 mg/d of magnesium, 4 mg/d of zinc, 2 mg/d of copper, 2 mg/d of manganese, 198 mg/d of potassium, 100 mg/d of trace mineral complex, and 2 mg/d of boron)<br>Dietary Supplement: Placebo<br>* Dextrose Placebo<br>|
| Experimental: High Protein Diet plus Exercise<br>High protein diet and exercise intervention | Dietary Supplement: Curves Calcium<br>* Dietary Supplement: Curves Calcium Curves Essential Bio-Available Calcium (providing 800 mg/d of calcium [as calcium citrate malate and calcium citrate], 400 IU of Vitamin D, 300 mg/d of magnesium, 4 mg/d of zinc, 2 mg/d of copper, 2 mg/d of manganese, 198 mg/d of potassium, 100 mg/d of trace mineral complex, and 2 mg/d of boron)<br>Dietary Supplement: Placebo<br>* Dextrose Placebo<br>|
| Experimental: High Carbohydrate Diet plus Exercise<br>High carbohydrate diet and exercise intervention | Dietary Supplement: Curves Calcium<br>* Dietary Supplement: Curves Calcium Curves Essential Bio-Available Calcium (providing 800 mg/d of calcium [as calcium citrate malate and calcium citrate], 400 IU of Vitamin D, 300 mg/d of magnesium, 4 mg/d of zinc, 2 mg/d of copper, 2 mg/d of manganese, 198 mg/d of potassium, 100 mg/d of trace mineral complex, and 2 mg/d of boron)<br>Dietary Supplement: Placebo<br>* Dextrose Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body Composition: Body Fat | Changes in body composition (% body fat) obtained via DXA and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's) | Measured prior to supplementation (Pre), and after 1, 2, 3, 4, 5 and 6 months | 
| Body Composition: Fat Free Mass | Changes in body composition (fat free mass) obtained via DXA and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's) | Measured prior to supplementation (Pre), and after 1, 2, 3, 4, 5 and 6 months | 
| Body Composition: Bone Mass | Changes in body composition (bone mass) obtained via DXA and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's) | Measured prior to supplementation (Pre), and after 1, 2, 3, 4, 5 and 6 months | 
| Body Composition: Fat Mass | Changes in body composition (fat mass) obtained via DXA and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's) | Measured prior to supplementation (Pre), and after 1, 2, 3, 4, 5 and 6 months | 
| Body Composition: Lean Mass | Changes in body composition (lean mass) obtained via DXA and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's) | Measured prior to supplementation (Pre), and after 1, 2, 3, 4, 5 and 6 months | 
| Body Composition: Body Weight | Changes in body composition (body weight) obtained via DXA and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's) | Measured prior to supplementation (Pre), and after 1, 2, 3, 4, 5 and 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Energy Homeostasis: Resting Energy Expenditure (REE) | Changes in REE obtained via metabolic cart and expressed in absolute (kcal/d) and relative terms kcals/kg/d) and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's) | Measured prior to supplementation (Pre), and after 1, 2, 3, 4, 5 and 6 months | 
| Energy Homeostasis: Respiratory Exchange Ratio (RER) | Changes in 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 with repeated measures and mean change from baseline with 95% confidence intervals (CI's) | Measured prior to supplementation (Pre), and after 1, 2, 3, 4, 5 and 6 months | 
| Muscular Strength: 1 Repetition Maximum (1 RM) Bench Press | Changes in bench press 1 RM obtained from a bench press test and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's) | Measured prior to supplementation (Pre), and after 3, and 6 months | 
| Muscular Strength: 1 Repetition Maximum (1 RM) Leg Press | Changes in bench press 1 RM obtained from a leg press test and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's) | Measured prior to supplementation (Pre), and after 3, and 6 months | 
| Muscular Endurance: 80% of 1 Repetition Maximum (1 RM) Bench Press Endurance Test | Changes in total repetitions at 80% of 1 RM obtained from a bench press test and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's) | Measured prior to supplementation (Pre), and after 3, and 6 months | 
| Muscular Endurance: 80% of 1 Repetition Maximum (1 RM) Leg Press Endurance Test | Changes in total repetitions at 80% of 1 RM obtained from a leg press test and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's) | Measured prior to supplementation (Pre), and after 3, and 6 months | 
| Cardiac Variable: Resting Electrocardiogram (ECG) | Changes in resting ECG obtained via electrodes and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's) | Measured prior to supplementation (Pre), and after 3, and 6 months | 
| Cardiac Variable: Graded Exercise Test (GXT) | Changes in exercise capacity obtained via a treadmill test and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's) | Measured prior to supplementation (Pre), and after 3, and 6 months | 
| Hemodynamic Variable: Resting Heart Rate (RHR) | Changes in resting heart rae (RHR) obtained via a blood pressure meter and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's) | Measured prior to supplementation (Pre), and after 1, 2, 3, 4, 5 and 6 months | 
| Hemodynamic Variable: Resting Systolic Blood Pressure (SBP) | Changes in resting systolic blood pressure (mmHg) analyzed with related resting hemodynamic outcome measures via General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's) | Measured prior to supplementation (Pre), and after 1, 2, 3, 4, 5 and 6 months | 
| Hemodynamic Variable: Resting Diastolic Blood Pressure (DBP) | Changes in resting diastolic blood pressure (mmHg) analyzed with related resting hemodynamic outcome measures via General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's) | Measured prior to supplementation (Pre), and after 1, 2, 3, 4, 5 and 6 months | 
| Anthropometric Measures: Waist Circumference | Changes in waist circumference obtained via tape measure and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's) | Measured prior to supplementation (Pre), and after 1, 2, 3, 4, 5 and 6 months | 
| Anthropometric Measures: Hip Circumference | Changes in hip circumference obtained via tape measure and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's) | Measured prior to supplementation (Pre), and after 1, 2, 3, 4, 5 and 6 months | 
| Anthropometric Measures: Waist to Hip Ratio | Changes in the ratio of waist to hip (waist/hip circumference) analyzed with related anthropometric outcome measures via General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's) | Measured prior to supplementation (Pre), and after 1, 2, 3, 4, 5 and 6 months | 
| Fasting Glucose | Changes in glucose obtained via venous blood draws and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's) | Measured prior to supplementation (Pre), and after 1, 2, 3, 4, 5 and 6 months | 
| Lipid Panel: Cholesterol | Changes in cholesterol obtained via venous blood draws and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's) | Measured prior to supplementation (Pre), and after 1, 2, 3, 4, 5 and 6 months | 
| Lipid Panel: HDL Cholesterol | Changes in HDL cholesterol obtained via venous blood draws and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's) | Measured prior to supplementation (Pre), and after 1, 2, 3, 4, 5 and 6 months | 
| Lipid Panel: Cholesterol to HDL Ratio | Changes in cholesterol to HDL ratio obtained via venous blood draws and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's) | Measured prior to supplementation (Pre), and after 1, 2, 3, 4, 5 and 6 months | 
| Lipid Panel: LDL Cholesterol | Changes in LDL cholesterol obtained via venous blood draws and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's) | Measured prior to supplementation (Pre), and after 1, 2, 3, 4, 5 and 6 months | 
| Lipid Panel: Triglycerides | Changes in triglycerides obtained via venous blood draws and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's) | Measured prior to supplementation (Pre), and after 1, 2, 3, 4, 5 and 6 months |