The Effect of Weight Loss on Bone in Men
The purpose of this study is to determine the effect of weight loss on bone health in men.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Nutritional Regulation of Bone - Pilot Study|
- Changes in bone density and quality [ Time Frame: 6 months ] [ Designated as safety issue: No ]
|Study Start Date:||March 2007|
|Study Completion Date:||April 2012|
|Primary Completion Date:||April 2012 (Final data collection date for primary outcome measure)|
weight loss (WL) with nutrition/behavior modification counseling
Behavioral: Weight Loss
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
Active Comparator: WM
Weight Maintenance (WM)
Behavioral: Weight Maintenance
Diet for weight maintenance for 6 months
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.
|United States, New Jersey|
|New Brunswick, New Jersey, United States, 08901|
|Principal Investigator:||Sue Shapses, PhD, RD||Rutgers University, Nutritional Sciences|