Clinical Trials Directory

Trials / Completed

CompletedNCT00472745

The Effect of Weight Loss on Bone in Men

Nutritional Regulation of Bone - Pilot Study

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
44 (actual)
Sponsor
Rutgers University · Academic / Other
Sex
Male
Age
50 Years – 72 Years
Healthy volunteers
Accepted

Summary

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

Detailed description

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALWeight LossWeight 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
BEHAVIORALWeight MaintenanceDiet for weight maintenance for 6 months

Timeline

Start date
2007-03-01
Primary completion
2012-04-01
Completion
2012-04-01
First posted
2007-05-14
Last updated
2023-04-26

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00472745. Inclusion in this directory is not an endorsement.