The Effect of Weight Loss on Bone in Men - Full Text View

Sponsor:	Rutgers University
Collaborator:	National Institute on Aging (NIA)
Information provided by (Responsible Party):	Sue Shapses, Rutgers University
ClinicalTrials.gov Identifier:	NCT00472745

Purpose

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

Condition	Intervention
Weight Loss Bone	Behavioral: Weight Loss Behavioral: Weight Maintenance

Study Type:	Interventional
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

Resource links provided by NLM:

MedlinePlus related topics: Bone Density Weight Control

U.S. FDA Resources

Further study details as provided by Rutgers University:

Primary Outcome Measures:

Changes in bone density and quality [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	32
Study Start Date:	March 2007
Estimated Study Completion Date:	August 2012
Estimated Primary Completion Date:	April 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: WL 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

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.

Eligibility

Ages Eligible for Study:	50 Years to 70 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

Criteria

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00472745

Locations

United States, New Jersey
Rutgers University
New Brunswick, New Jersey, United States, 08901

Sponsors and Collaborators

Rutgers University

National Institute on Aging (NIA)

Investigators

Principal Investigator:

Sue Shapses, PhD, RD

Rutgers University, Nutritional Sciences

More Information

Publications:

Shapses SA, Riedt CS. Bone, body weight, and weight reduction: what are the concerns? J Nutr. 2006 Jun;136(6):1453-6. Review.

Riedt CS, Cifuentes M, Stahl T, Chowdhury HA, Schlussel Y, Shapses SA. Overweight postmenopausal women lose bone with moderate weight reduction and 1 g/day calcium intake. J Bone Miner Res. 2005 Mar;20(3):455-63. Epub 2004 Nov 29.

Cifuentes M, Riedt CS, Brolin RE, Field MP, Sherrell RM, Shapses SA. Weight loss and calcium intake influence calcium absorption in overweight postmenopausal women. Am J Clin Nutr. 2004 Jul;80(1):123-30. Erratum in: Am J Clin Nutr. 2005 Jan;81(1):199.

Goode LR, Brolin RE, Chowdhury HA, Shapses SA. Bone and gastric bypass surgery: effects of dietary calcium and vitamin D. Obes Res. 2004 Jan;12(1):40-7.

Responsible Party:	Sue Shapses, Professor, Rutgers University
ClinicalTrials.gov Identifier:	NCT00472745 History of Changes
Other Study ID Numbers:	AG0084, 5R01AG012161, RO1-AG12161
Study First Received:	May 10, 2007
Last Updated:	December 25, 2011
Health Authority:	United States: Federal Government

Keywords provided by Rutgers University:

bone mass
calcium absorption
bone quality

fracture risk
arthritis
osteoporosis

Additional relevant MeSH terms:

Body Weight
Weight Loss
Signs and Symptoms
Body Weight Changes

ClinicalTrials.gov processed this record on February 12, 2012