The Effect of Weight Loss on Bone in Men

Study Overview
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Brief Summary
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The purpose of this study is to determine the effect of weight loss on bone health in men.

Detailed Description
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This pilot study of the effect of weight loss on bone health in men is being undertaken in conjunction with studies of the effect of weight loss on bone health in women for comparison purposes. See NCT00473031, NCT00472680, and NCT00472654. This information is important for determining optimal nutrient requirements during weight loss. Participants will be recruited for both weight loss and weight maintenance. All participants will be asked to take a daily vitamin/mineral supplement and, depending on their usual food intake, they may be asked to take a calcium tablet to meet the recommended intake throughout the study period. Weight loss participants will attend regular counseling sessions (about 45 minutes each) with a dietitian for approximately 6 months; they will be asked to attend 6 sessions but will be given the opportunity to attend 13 sessions. Body composition will be measured by a dual-energy x-ray absorptiometry (DXA) machine, ultrasound, and peripheral quantitative computer tomography (pQCT) before and after 6 months of weight loss. Bone, mineral, protein and lipid markers, and hormones that influence bones will also be measured.

Official Title
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Nutritional Regulation of Bone - Pilot Study

Conditions
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Weight Loss, BMD

Intervention / Treatment
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* Behavioral: Weight Loss
* Behavioral: Weight Maintenance


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Obese or overweight Must live in the geographic vicinity of Rutgers University Exclusion Criteria: Currently on any medication known to influence calcium or bone metabolism, including HRT, or with evidence of diseases known to influence calcium metabolism (i.e. metabolic bone disease, hyperparathyroidism, untreated thyroid disease, significant immune, hepatic, or renal disease, significant cardiac disease [i.e., heart attack or stroke in the past 6 months., abnormal EKG], active malignancy or cancer therapy within the past year) History of kidney stones Weight gain or weight loss (5% of body wt) within 3 months prior to recruitment Participation in other investigational studies during the 12-month study period Usually have a very high or low intake of calcium (more than 1500 or less than 500 mg per day)

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 72 Years

Sexes Eligible for Study
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Male

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: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: WL<br>weight loss (WL) with nutrition/behavior modification counseling | Behavioral: Weight Loss<br>* Weight loss participants will consume a reduced calorie diet based on their individual caloric needs to lose 1.5-2 lbs/week, and will attend regular counseling sessions (for about 45 minutes each) with a dietitian for 6 months<br>|
| Active Comparator: WM<br>Weight Maintenance (WM) | Behavioral: Weight Maintenance<br>* Diet for weight maintenance for 6 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in bone density and quality |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bone mass, calcium absorption, bone quality, fracture risk, arthritis, osteoporosis