Clinical trial NCT04344821: Curves 30/30 Study
Official title: Effects of Repeated Short-Term Diets on Weight Loss in Women Participating in the Curves Fitness Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Weight Loss
Lead sponsor: Texas A&M University
Sponsor class: OTHER
Collaborators: name: Curves International
First posted: 2020-04-14
Enrollment: 57
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, placebo controlled, repeated measures intervention trial
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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;

Primary outcomes:
measure: Body Composition: Body Fat
timeFrame: Measured prior to supplementation (Pre), and after 1, 2, 3, 4, 5 and 6 months
measure: Body Composition: Fat Free Mass
timeFrame: Measured prior to supplementation (Pre), and after 1, 2, 3, 4, 5 and 6 months
measure: Body Composition: Bone Mass
timeFrame: Measured prior to supplementation (Pre), and after 1, 2, 3, 4, 5 and 6 months
measure: Body Composition: Fat Mass
timeFrame: Measured prior to supplementation (Pre), and after 1, 2, 3, 4, 5 and 6 months
measure: Body Composition: Lean Mass
timeFrame: Measured prior to supplementation (Pre), and after 1, 2, 3, 4, 5 and 6 months
measure: Body Composition: Body Weight
timeFrame: Measured prior to supplementation (Pre), and after 1, 2, 3, 4, 5 and 6 months
Secondary outcomes:
measure: Energy Homeostasis: Resting Energy Expenditure (REE)
timeFrame: Measured prior to supplementation (Pre), and after 1, 2, 3, 4, 5 and 6 months
measure: Energy Homeostasis: Respiratory Exchange Ratio (RER)
timeFrame: Measured prior to supplementation (Pre), and after 1, 2, 3, 4, 5 and 6 months
measure: Muscular Strength: 1 Repetition Maximum (1 RM) Bench Press
timeFrame: Measured prior to supplementation (Pre), and after 3, and 6 months
measure: Muscular Strength: 1 Repetition Maximum (1 RM) Leg Press
timeFrame: Measured prior to supplementation (Pre), and after 3, and 6 months
measure: Muscular Endurance: 80% of 1 Repetition Maximum (1 RM) Bench Press Endurance Test
timeFrame: Measured prior to supplementation (Pre), and after 3, and 6 months
measure: Muscular Endurance: 80% of 1 Repetition Maximum (1 RM) Leg Press Endurance Test
timeFrame: Measured prior to supplementation (Pre), and after 3, and 6 months
measure: Cardiac Variable: Resting Electrocardiogram (ECG)
timeFrame: Measured prior to supplementation (Pre), and after 3, and 6 months
measure: Cardiac Variable: Graded Exercise Test (GXT)
timeFrame: Measured prior to supplementation (Pre), and after 3, and 6 months
measure: Hemodynamic Variable: Resting Heart Rate (RHR)
timeFrame: Measured prior to supplementation (Pre), and after 1, 2, 3, 4, 5 and 6 months
measure: Hemodynamic Variable: Resting Systolic Blood Pressure (SBP)
timeFrame: Measured prior to supplementation (Pre), and after 1, 2, 3, 4, 5 and 6 months
measure: Hemodynamic Variable: Resting Diastolic Blood Pressure (DBP)
timeFrame: Measured prior to supplementation (Pre), and after 1, 2, 3, 4, 5 and 6 months
measure: Anthropometric Measures: Waist Circumference
timeFrame: Measured prior to supplementation (Pre), and after 1, 2, 3, 4, 5 and 6 months
measure: Anthropometric Measures: Hip Circumference
timeFrame: Measured prior to supplementation (Pre), and after 1, 2, 3, 4, 5 and 6 months
measure: Anthropometric Measures: Waist to Hip Ratio
timeFrame: Measured prior to supplementation (Pre), and after 1, 2, 3, 4, 5 and 6 months
measure: Fasting Glucose
timeFrame: Measured prior to supplementation (Pre), and after 1, 2, 3, 4, 5 and 6 months
measure: Lipid Panel: Cholesterol
timeFrame: Measured prior to supplementation (Pre), and after 1, 2, 3, 4, 5 and 6 months
measure: Lipid Panel: HDL Cholesterol
timeFrame: Measured prior to supplementation (Pre), and after 1, 2, 3, 4, 5 and 6 months
measure: Lipid Panel: Cholesterol to HDL Ratio
timeFrame: Measured prior to supplementation (Pre), and after 1, 2, 3, 4, 5 and 6 months
measure: Lipid Panel: LDL Cholesterol
timeFrame: Measured prior to supplementation (Pre), and after 1, 2, 3, 4, 5 and 6 months
measure: Lipid Panel: Triglycerides
timeFrame: Measured prior to supplementation (Pre), and after 1, 2, 3, 4, 5 and 6 months
Other outcomes:
Locations:
city: College Station
country: United States
facility: Exercise & Sport Nutrition Laboratory
state: Texas
Study officials:
References: