Clinical trial NCT03878667: Effects of Calcium Supplementation on Women in the Curves for Women Program
Official title: Effects of Calcium Supplementation on Body Composition, Metabolism and Exercise Capacity in Post-Menopausal Women Participating in the Curves for Women Fitness and Weight Loss Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diet Modification
Keywords: Calcium Supplementation
Exercise Intervention
Lead sponsor: Texas A&M University
Sponsor class: OTHER
First posted: 2019-03-18
Enrollment: 240
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study is to examine the effects of dietary calcium supplementation on weight loss, bone density, and markers of health and fitness in women participating in the Curves exercise and diet program.

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 Lab 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/diet program. The purpose of this study is to examine the effect of dietary calcium supplementation on weight loss, bone density, and markers of health and fitness in women participating in the Curves exercise and diet program.

Eligibility criteria: Inclusion Criteria:

* Participant is female;
* Participant is post-menopausal;
* Participant is between the ages of 45 and 65;
* Participant is sedentary, overweight (BMI \> 27) and post-menopausal;

Exclusion Criteria:

* Participant has any metabolic disorder 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.g., 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), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
measure: Body Composition: Fat Free Mass
timeFrame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
measure: Body Composition: Bone Mass
timeFrame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
measure: Body Composition: Fat Mass
timeFrame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
measure: Body Composition: Lean Mass
timeFrame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
measure: Body Composition: Body Weight
timeFrame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
measure: Energy Homeostasis: Resting Energy Expenditure (REE)
timeFrame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
measure: Energy Homeostasis: Respiratory Exchange Ratio (RER)
timeFrame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Secondary outcomes:
measure: Muscular Strength: 1 Repetition Maximum (1RM) Bench Press
timeFrame: Measured prior to supplementation (Pre), after 10 weeks and 14 weeks
measure: Muscular Strength: 1 Repetition Maximum (1RM) Leg Press
timeFrame: Measured prior to supplementation (Pre), after 10 weeks and 14 weeks
measure: Muscular Endurance: 80% of 1 Repetition Maximum (1RM) Bench Press Endurance Test
timeFrame: Measured prior to supplementation (Pre), after 10 weeks and 14 weeks
measure: Muscular Endurance: 80% of 1 Repetition Maximum (1RM) Leg Press Endurance Test
timeFrame: Measured prior to supplementation (Pre), after 10 weeks and 14 weeks
measure: Body Composition: Body Water
timeFrame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
measure: Lipid Panel: Cholesterol
timeFrame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
measure: Lipid Panel: HDL Cholesterol
timeFrame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
measure: Lipid Panel: LDL Cholesterol
timeFrame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
measure: Lipid Panel: Triglycerides
timeFrame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
measure: Comprehensive Metabolic Panel - CMP: Glucose
timeFrame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
measure: Comprehensive Metabolic Panel - CMP: Calcium
timeFrame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
measure: Comprehensive Metabolic Panel - CMP: Albumin
timeFrame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
measure: Comprehensive Metabolic Panel - CMP: Total Protein
timeFrame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
measure: Comprehensive Metabolic Panel - CMP: Sodium
timeFrame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
measure: Comprehensive Metabolic Panel - CMP: Potassium
timeFrame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
measure: Comprehensive Metabolic Panel - CMP: Carbon Dioxide (CO2)
timeFrame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
measure: Comprehensive Metabolic Panel - CMP: Chloride
timeFrame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
measure: Comprehensive Metabolic Panel - CMP: Blood Urea Nitrogen (BUN)
timeFrame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
measure: Comprehensive Metabolic Panel - CMP: Creatinine
timeFrame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
measure: Comprehensive Metabolic Panel - CMP: Alkaline Phosphatase (ALP)
timeFrame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
measure: Comprehensive Metabolic Panel - CMP: Amino Transferase (ALT)
timeFrame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
measure: Comprehensive Metabolic Panel - CMP: Amino Transferase (AST)
timeFrame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
measure: Comprehensive Metabolic Panel - CMP: Bilirubin
timeFrame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
measure: Complete Blood Count - CBC: White Blood Cell (WBC) Count
timeFrame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
measure: Complete Blood Count - CBC: White Blood Cell Differential
timeFrame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
measure: Complete Blood Count - CBC: Red Blood Cell (RBC) Count
timeFrame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
measure: Complete Blood Count - CBC: Red Cell Distribution Width (RDW)
timeFrame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
measure: Complete Blood Count - CBC: Hemoglobin
timeFrame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
measure: Complete Blood Count - CBC: Hematocrit
timeFrame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
measure: Complete Blood Count - CBC: Platelet Count
timeFrame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
measure: Complete Blood Count - CBC: Mean Platelet Volume (MPV)
timeFrame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
measure: Complete Blood Count - CBC: Neutrophils
timeFrame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
measure: Complete Blood Count - CBC: Lymphocytes
timeFrame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
measure: Complete Blood Count - CBC: Basophils
timeFrame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
measure: Complete Blood Count - CBC: Eosinophils
timeFrame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
measure: Complete Blood Count - CBC: Monocytes
timeFrame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
measure: Complete Blood Count - CBC: Mean Corpuscular Volume (MCV)
timeFrame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
measure: Complete Blood Count - CBC: Mean Corpuscular Hemoglobin (MCH)
timeFrame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
measure: Complete Blood Count - CBC: Mean Corpuscular Hemoglobin Concentration (MCHC)
timeFrame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
measure: Hormones: Insulin
timeFrame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
measure: Hormones: Leptin
timeFrame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
measure: Hemodynamic Variable: Resting Heart Rate (HR)
timeFrame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
measure: Hemodynamic Variable: Resting Systolic Blood Pressure (SBP)
timeFrame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
measure: Hemodynamic Variable: Resting Diastolic Blood Pressure (DBP)
timeFrame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
measure: Anthropometric Measures: Waist Circumference
timeFrame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
measure: Anthropometric Measures: Hip Circumference
timeFrame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
measure: Anthropometric Measures: Waist to Hip Ratio
timeFrame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
measure: Anthropometric Measures: Body Mass Index
timeFrame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
measure: Cardiac Variable: Resting Electrocardiogram (ECG)
timeFrame: Measured prior to supplementation (Pre), after 10 weeks and 14 weeks
measure: Exercise Capacity: Graded Exercise Test (GXT)
timeFrame: Measured prior to supplementation (Pre), after 10 weeks and 14 weeks
measure: Subjective Rating of Quality of Life
timeFrame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
measure: Subjective Rating of Appetite
timeFrame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
measure: Subjective Rating of Hunger
timeFrame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
measure: Subjective Rating of Satisfaction from Food
timeFrame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
measure: Subjective Rating of Feelings of Fullness
timeFrame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
measure: Subjective Rating of Amount of Energy
timeFrame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
measure: Subjective Rating of Overall Quality of Diet
timeFrame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
measure: Dietary Energy Intake - Total Caloric Intake
timeFrame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
measure: Dietary Energy Intake - Carbohydrate
timeFrame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
measure: Dietary Energy Intake - Fat
timeFrame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
measure: Dietary Energy Intake - Protein
timeFrame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
measure: Perceptions of Side Effects - Dizziness
timeFrame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
measure: Perceptions of Side Effects - Headache
timeFrame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
measure: Perceptions of Side Effects - Tachycardia
timeFrame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
measure: Perceptions of Side Effects - Palpitations
timeFrame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
measure: Perceptions of Side Effects - Dyspnea
timeFrame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
measure: Perceptions of Side Effects - Nervousness
timeFrame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
measure: Perceptions of Side Effects - Blurred Vision
timeFrame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
measure: Perceptions of Side Effects - Other Side Effects
timeFrame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Texas A&M University
name: Richard B Kreider, PhD
role: PRINCIPAL_INVESTIGATOR
References: