The Effect of Weight Loss on Bone in Men
Primary Purpose
Weight Loss, BMD
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Weight Loss
Weight Maintenance
Sponsored by
About this trial
This is an interventional treatment trial for Weight Loss focused on measuring bone mass, calcium absorption, bone quality, fracture risk, arthritis, osteoporosis
Eligibility 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)
Sites / Locations
- Rutgers University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
WL
WM
Arm Description
weight loss (WL) with nutrition/behavior modification counseling
Weight Maintenance (WM)
Outcomes
Primary Outcome Measures
Changes in bone density and quality
Secondary Outcome Measures
Full Information
NCT ID
NCT00472745
First Posted
May 10, 2007
Last Updated
April 24, 2023
Sponsor
Rutgers University
Collaborators
National Institute on Aging (NIA)
1. Study Identification
Unique Protocol Identification Number
NCT00472745
Brief Title
The Effect of Weight Loss on Bone in Men
Official Title
Nutritional Regulation of Bone - Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
March 2007 (undefined)
Primary Completion Date
April 2012 (Actual)
Study Completion Date
April 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rutgers University
Collaborators
National Institute on Aging (NIA)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Weight Loss, BMD
Keywords
bone mass, calcium absorption, bone quality, fracture risk, arthritis, osteoporosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
44 (Actual)
8. Arms, Groups, and Interventions
Arm Title
WL
Arm Type
Experimental
Arm Description
weight loss (WL) with nutrition/behavior modification counseling
Arm Title
WM
Arm Type
Active Comparator
Arm Description
Weight Maintenance (WM)
Intervention Type
Behavioral
Intervention Name(s)
Weight Loss
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
Weight Maintenance
Intervention Description
Diet for weight maintenance for 6 months
Primary Outcome Measure Information:
Title
Changes in bone density and quality
Time Frame
6 months
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
72 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sue Shapses, PhD, RD
Organizational Affiliation
Rutgers University, Nutritional Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rutgers University
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
16702302
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.
Results Reference
background
PubMed Identifier
15746990
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.
Results Reference
background
PubMed Identifier
15213038
Citation
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.
Results Reference
background
PubMed Identifier
14742841
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.
Results Reference
background
PubMed Identifier
25733651
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.
Results Reference
background
PubMed Identifier
35538903
Citation
Ogilvie AR, Schlussel Y, Sukumar D, Meng L, Shapses SA. Higher protein intake during caloric restriction improves diet quality and attenuates loss of lean body mass. Obesity (Silver Spring). 2022 Jul;30(7):1411-1419. doi: 10.1002/oby.23428. Epub 2022 May 11.
Results Reference
derived
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The Effect of Weight Loss on Bone in Men
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