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NCT00472745 Clinical Trial

The Effect of Weight Loss on Bone in Men

Weight Loss Clinical Trial

Official title:
Nutritional Regulation of Bone - Pilot Study

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00472745
Other study ID # AG0084
Secondary ID 5R01AG012161
Status Completed
Phase N/A
First received
Last updated
Start date March 2007
Est. completion date April 2012

Study information
Verified date January 2022
Source Rutgers, The State University of New Jersey
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 44
Est. completion date April 2012
Est. primary completion date April 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 50 Years to 72 Years
Eligibility 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)

Study Design

Related Conditions & MeSH terms

Intervention

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
• Weight Maintenance
Diet for weight maintenance for 6 months

Locations
Country Name City State
United States Rutgers University New Brunswick New Jersey

Sponsors (2)
Lead Sponsor Collaborator
Rutgers University National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. doi: 10.1093/ajcn/80.1.123. Erratum In: Am J Clin Nutr. 2005 Jan;81(1):199. — View Citation

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. doi: 10.1038/oby.2004.7. — View Citation

Pop LC, Sukumar D, Tomaino K, Schlussel Y, Schneider SH, Gordon CL, Wang X, Shapses SA. Moderate weight loss in obese and overweight men preserves bone quality. Am J Clin Nutr. 2015 Mar;101(3):659-67. doi: 10.3945/ajcn.114.088534. Epub 2015 Jan 7. — View Citation

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. doi: 10.1359/JBMR.041132. Epub 2004 Nov 29. — View Citation

Shapses SA, Riedt CS. Bone, body weight, and weight reduction: what are the concerns? J Nutr. 2006 Jun;136(6):1453-6. doi: 10.1093/jn/136.6.1453. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Changes in bone density and quality 6 months
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