The Effect of Weight Loss on Bone in Men

Rutgers The State University of New Jersey logo

Rutgers The State University of New Jersey

Status

Completed

Conditions

Weight Loss
BMD

Treatments

Behavioral: Weight Loss
Behavioral: Weight Maintenance

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT00472745
5R01AG012161 (U.S. NIH Grant/Contract)
AG0084

Details and patient eligibility

About

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

Full 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.

Enrollment

44 patients

Sex

Male

Ages

50 to 72 years old

Volunteers

Accepts Healthy Volunteers

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)

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

44 participants in 2 patient groups

WL
Experimental group
Description:
weight loss (WL) with nutrition/behavior modification counseling
Treatment:
Behavioral: Weight Loss
WM
Active Comparator group
Description:
Weight Maintenance (WM)
Treatment:
Behavioral: Weight Maintenance

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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