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Curves 30/30 Study (C-30)

Primary Purpose

Weight Loss

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Curves Calcium
Placebo
Sponsored by
Texas A&M University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Weight Loss

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

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;

Sites / Locations

  • Exercise & Sport Nutrition Laboratory

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Experimental

Experimental

Experimental

Arm Label

Control

No Diet plus Exercise

High Protein Diet plus Exercise

High Carbohydrate Diet plus Exercise

Arm Description

No diet or exercise intervention

No diet, exercise only intervention

High protein diet and exercise intervention

High carbohydrate diet and exercise intervention

Outcomes

Primary Outcome Measures

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)
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)
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)
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)
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)
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)

Secondary Outcome Measures

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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)

Full Information

First Posted
April 9, 2020
Last Updated
April 13, 2020
Sponsor
Texas A&M University
Collaborators
Curves International
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1. Study Identification

Unique Protocol Identification Number
NCT04344821
Brief Title
Curves 30/30 Study
Acronym
C-30
Official Title
Effects of Repeated Short-Term Diets on Weight Loss in Women Participating in the Curves Fitness Program
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
May 18, 2009 (undefined)
Primary Completion Date
May 3, 2012 (Actual)
Study Completion Date
May 3, 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Texas A&M University
Collaborators
Curves International

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Weight Loss

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized, placebo controlled, repeated measures intervention trial
Masking
Investigator
Masking Description
Double (Participant, Investigator)
Allocation
Randomized
Enrollment
57 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
No diet or exercise intervention
Arm Title
No Diet plus Exercise
Arm Type
Experimental
Arm Description
No diet, exercise only intervention
Arm Title
High Protein Diet plus Exercise
Arm Type
Experimental
Arm Description
High protein diet and exercise intervention
Arm Title
High Carbohydrate Diet plus Exercise
Arm Type
Experimental
Arm Description
High carbohydrate diet and exercise intervention
Intervention Type
Dietary Supplement
Intervention Name(s)
Curves Calcium
Intervention Description
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)
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Dextrose Placebo
Primary Outcome Measure Information:
Title
Body Composition: Body Fat
Description
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)
Time Frame
Measured prior to supplementation (Pre), and after 1, 2, 3, 4, 5 and 6 months
Title
Body Composition: Fat Free Mass
Description
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)
Time Frame
Measured prior to supplementation (Pre), and after 1, 2, 3, 4, 5 and 6 months
Title
Body Composition: Bone Mass
Description
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)
Time Frame
Measured prior to supplementation (Pre), and after 1, 2, 3, 4, 5 and 6 months
Title
Body Composition: Fat Mass
Description
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)
Time Frame
Measured prior to supplementation (Pre), and after 1, 2, 3, 4, 5 and 6 months
Title
Body Composition: Lean Mass
Description
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)
Time Frame
Measured prior to supplementation (Pre), and after 1, 2, 3, 4, 5 and 6 months
Title
Body Composition: Body Weight
Description
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)
Time Frame
Measured prior to supplementation (Pre), and after 1, 2, 3, 4, 5 and 6 months
Secondary Outcome Measure Information:
Title
Energy Homeostasis: Resting Energy Expenditure (REE)
Description
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)
Time Frame
Measured prior to supplementation (Pre), and after 1, 2, 3, 4, 5 and 6 months
Title
Energy Homeostasis: Respiratory Exchange Ratio (RER)
Description
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)
Time Frame
Measured prior to supplementation (Pre), and after 1, 2, 3, 4, 5 and 6 months
Title
Muscular Strength: 1 Repetition Maximum (1 RM) Bench Press
Description
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)
Time Frame
Measured prior to supplementation (Pre), and after 3, and 6 months
Title
Muscular Strength: 1 Repetition Maximum (1 RM) Leg Press
Description
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)
Time Frame
Measured prior to supplementation (Pre), and after 3, and 6 months
Title
Muscular Endurance: 80% of 1 Repetition Maximum (1 RM) Bench Press Endurance Test
Description
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)
Time Frame
Measured prior to supplementation (Pre), and after 3, and 6 months
Title
Muscular Endurance: 80% of 1 Repetition Maximum (1 RM) Leg Press Endurance Test
Description
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)
Time Frame
Measured prior to supplementation (Pre), and after 3, and 6 months
Title
Cardiac Variable: Resting Electrocardiogram (ECG)
Description
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)
Time Frame
Measured prior to supplementation (Pre), and after 3, and 6 months
Title
Cardiac Variable: Graded Exercise Test (GXT)
Description
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)
Time Frame
Measured prior to supplementation (Pre), and after 3, and 6 months
Title
Hemodynamic Variable: Resting Heart Rate (RHR)
Description
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)
Time Frame
Measured prior to supplementation (Pre), and after 1, 2, 3, 4, 5 and 6 months
Title
Hemodynamic Variable: Resting Systolic Blood Pressure (SBP)
Description
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)
Time Frame
Measured prior to supplementation (Pre), and after 1, 2, 3, 4, 5 and 6 months
Title
Hemodynamic Variable: Resting Diastolic Blood Pressure (DBP)
Description
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)
Time Frame
Measured prior to supplementation (Pre), and after 1, 2, 3, 4, 5 and 6 months
Title
Anthropometric Measures: Waist Circumference
Description
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)
Time Frame
Measured prior to supplementation (Pre), and after 1, 2, 3, 4, 5 and 6 months
Title
Anthropometric Measures: Hip Circumference
Description
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)
Time Frame
Measured prior to supplementation (Pre), and after 1, 2, 3, 4, 5 and 6 months
Title
Anthropometric Measures: Waist to Hip Ratio
Description
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)
Time Frame
Measured prior to supplementation (Pre), and after 1, 2, 3, 4, 5 and 6 months
Title
Fasting Glucose
Description
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)
Time Frame
Measured prior to supplementation (Pre), and after 1, 2, 3, 4, 5 and 6 months
Title
Lipid Panel: Cholesterol
Description
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)
Time Frame
Measured prior to supplementation (Pre), and after 1, 2, 3, 4, 5 and 6 months
Title
Lipid Panel: HDL Cholesterol
Description
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)
Time Frame
Measured prior to supplementation (Pre), and after 1, 2, 3, 4, 5 and 6 months
Title
Lipid Panel: Cholesterol to HDL Ratio
Description
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)
Time Frame
Measured prior to supplementation (Pre), and after 1, 2, 3, 4, 5 and 6 months
Title
Lipid Panel: LDL Cholesterol
Description
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)
Time Frame
Measured prior to supplementation (Pre), and after 1, 2, 3, 4, 5 and 6 months
Title
Lipid Panel: Triglycerides
Description
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)
Time Frame
Measured prior to supplementation (Pre), and after 1, 2, 3, 4, 5 and 6 months

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Sedentary and overweight female participants between the ages of 18 and 45 participated in this study.
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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;
Facility Information:
Facility Name
Exercise & Sport Nutrition Laboratory
City
College Station
State/Province
Texas
ZIP/Postal Code
77843
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Curves 30/30 Study

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