Curves 30/30 Study

NCT04344821 | Completed DMC

• 1 other identifier: IRB2008-0480
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

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.

Conditions

Weight Loss

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (20)

• Energy Homeostasis: Resting Energy Expenditure (REE)

  Measured prior to supplementation (Pre), and after 1, 2, 3, 4, 5 and 6 months

• Energy Homeostasis: Respiratory Exchange Ratio (RER)

  Measured prior to supplementation (Pre), and after 1, 2, 3, 4, 5 and 6 months

• Muscular Strength: 1 Repetition Maximum (1 RM) Bench Press

  Measured prior to supplementation (Pre), and after 3, and 6 months

• Muscular Strength: 1 Repetition Maximum (1 RM) Leg Press

  Measured prior to supplementation (Pre), and after 3, and 6 months

• Muscular Endurance: 80% of 1 Repetition Maximum (1 RM) Bench Press Endurance Test

  Measured prior to supplementation (Pre), and after 3, and 6 months

Study Arms (4)

Control

PLACEBO COMPARATOR

No diet or exercise intervention

Dietary Supplement: Curves Calcium; Dietary Supplement: Placebo

No Diet plus Exercise

EXPERIMENTAL

No diet, exercise only intervention

Dietary Supplement: Curves Calcium; Dietary Supplement: Placebo

High Protein Diet plus Exercise

EXPERIMENTAL

High protein diet and exercise intervention

Dietary Supplement: Curves Calcium; Dietary Supplement: Placebo

High Carbohydrate Diet plus Exercise

EXPERIMENTAL

High carbohydrate diet and exercise intervention

Dietary Supplement: Curves Calcium; Dietary Supplement: Placebo

Interventions

Curves Calcium DIETARY_SUPPLEMENT

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)

Control; High Carbohydrate Diet plus Exercise; High Protein Diet plus Exercise; No Diet plus Exercise

Placebo DIETARY_SUPPLEMENT

Dextrose Placebo

Control; High Carbohydrate Diet plus Exercise; High Protein Diet plus Exercise; No Diet plus Exercise

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Sedentary and overweight female participants between the ages of 18 and 45 participated in this study.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Texas A&M University: lead
• Curves International: collaborator

Study Sites (1)

Exercise & Sport Nutrition Laboratory

College Station, Texas, 77843, United States

Location

MeSH Terms

Conditions

Weight Loss

Condition Hierarchy (Ancestors)

Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Double (Participant, Investigator)
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Executive Director, Human Clinical Research Facility

Model Details: Randomized, placebo controlled, repeated measures intervention trial

Study Record Dates

• First Submitted: April 9, 2020
• First Posted: April 14, 2020
• Study Start: May 18, 2009
• Primary Completion: May 3, 2012
• Study Completion: May 3, 2012
• Last Updated: April 15, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)