Calcium Supplementation for a Healthy Weight-Lite (CaSHeW Lite)

Study Overview
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Brief Summary
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The purpose of the study is to find out if taking calcium and vitamin D supplements, while following a low-calorie diet, can help people lose weight.

Detailed Description
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Recent studies suggest that calcium may be important for weight loss, but other studies have not had the same results. The purpose of the study is to find out if taking calcium and vitamin D supplements, while following a low-calorie diet, can help people lose weight. We will use special orange juice with less calories than regular orange juice. Half of the subjects in this study will drink the study juice (reduced-calorie orange juice) containing extra calcium and vitamin D. The other subjects will drink reduced-calorie orange juice without any extra calcium or vitamin D in it. Comparisons: We will compare subjects who follow the diet and take calcium and vitamin D supplements to those who only follow the diet.

Official Title
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Calcium Supplementation for a Healthy Weight- LITE

Conditions
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Obesity, Overweight

Intervention / Treatment
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* Dietary Supplement: Reduced energy (lite) OJ fortified with Calcium and Vitamin D
* Behavioral: Nutrition Counseling
* Dietary Supplement: Reduced energy (lite) OJ without Calcium and Vitamin D


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men or women, between 18 and 65 years of age, who are capable of providing informed consent. BMI of 25 to 35 kg/m2. Non-smoker (for at least 6 months). In good health, as determined by the principal investigator based on medical history and physical examination. Clinical laboratory evaluations (including Biochemistry, Hematology, Endocrinology) within the reference range for the test laboratory, unless deemed not clinically significant by the Investigator. Because of the calorie-restricted diet and radiation exposure from the CT scan, females will be non-pregnant, non-lactating, and either post-menopausal for at least 1 year, surgically sterile for at least 3 months, or be willing to use an approved method of contraception (which may include use of abstinence; intrauterine device; female condom with spermicide; diaphragm with spermicide; cervical cap with spermicide; oral or transdermal hormonal contraceptives; a condom with spermicide by the sexual partner; or a sterile sexual partner) from 35 days prior to study entry (i.e., Day -1) until 30 days following Study Completion. For all females, the pregnancy test result must be negative at the screening visit and at visits when a CT scan will be done. Ability to comprehend and willingness to sign the Informed Consent Form for this study. Ability to comply with study restrictions regarding diet and exercise. Stable weight (+ 5%) for at least 3 months prior to study entry. Exclusion Criteria: Diabetes mellitus. History or clinical manifestations of significant metabolic, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, urological, neurological, or psychiatric disorders which in the opinion of the investigator would be expected to interfere with the study or increase risk to the subject. Participation in any other investigational diet study within 90 days prior to study entry. History of a medical or psychological condition or social circumstances that would impair the subject's ability to participate reliably in the study. Use within the last six months of medications that can result in significant weight gain or weight loss, including antipsychotics, selective serotonin reuptake inhibitors, anti-epileptic drugs, appetite-suppressants such as phentermine and sibutramine, and the lipase-inhibitor orlistat. (see Appendix 1 for detailed list) Active eating disorder. History of alcoholism or substance abuse within 5 years prior to study entry. Recommendation by a physician to avoid calcium supplements because of a history of kidney stones or other medical condition. History of hyperparathyroidism or sarcoidosis. Osteoporosis or other medical condition for which a physician has recommended taking a multivitamin or calcium supplementation. High calcium intake (more than 2 servings of dairy products per day or taking calcium supplements > 3x/wk ) for 1 month prior to study start date and for duration of study. (If participant is taking calcium supplement > 3x/wk or more than 2 servings of dairy products per day, they are eligible to participate if they agree to stop for 1 month prior to study start date and for the duration of the study. Participants will similarly be asked to stop multivitamins as the majority of these supplements contain calcium.) General medical conditions that are well-controlled will not be a basis for exclusion in the study. Subjects with uncontrolled conditions that are not adequately controlled or that might pose an unacceptable risk for participation, as clinically determined by the investigators, will be excluded.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lite OJ with Ca and VitD<br>240ml of reduced energy (lite) OJ beverage fortified with 350mg Ca and 100U VitD, 3 times per day. | Dietary Supplement: Reduced energy (lite) OJ fortified with Calcium and Vitamin D<br>* Three 240ml servings of lite OJ fortified with 350mg Ca and 100U VitD per day.<br>* Other names: Minute Maid Light Orange Juice;Behavioral: Nutrition Counseling<br>* Individual and group nutritional counseling by a registered dietician.<br>|
| Active Comparator: Lite OJ without Ca and VitD<br>240ml of reduced energy (lite) OJ beverage, 3 times per day. | Behavioral: Nutrition Counseling<br>* Individual and group nutritional counseling by a registered dietician.<br>Dietary Supplement: Reduced energy (lite) OJ without Calcium and Vitamin D<br>* Three 240ml servings of lite OJ without 350mg Ca and 100U VitD per day.<br>* Other names: Minute Maid Light Orange Juice;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in body weight |  | Baseline and at 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in visceral adipose tissue mass |  | Baseline and at 16 weeks | 
| Change in subcutaneous adipose tissue mass |  | Baseline and at 16 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Calcium, Vitamin D, Weight Loss, Overweight, Obesity, Lite Orange Juice