The Effect of Weight Loss and Dietary Protein Intake on Bone
NCT ID: NCT00473031
Last Updated: 2023-04-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
60 participants
INTERVENTIONAL
2007-03-31
2010-06-30
Brief Summary
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Detailed Description
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Participants will be randomly assigned to one of 2 groups: A) weight loss with recommended level of protein intake, and B) weight loss with higher protein intake. All participants will attend regular counseling sessions (about 50 minutes per session) with a dietitian for approximately 1 year, and will be asked to take a daily vitamin/mineral supplement. Also, depending on their usual food intake, they may be asked to take a calcium tablet to meet the recommended intake throughout the study period. Bone, mineral, protein and lipid markers, and hormones that influence bones will be measured. These measurements will provide information about body composition (fat, muscle mass, and bone mineral density). Participants will be asked to attend 8 diet counseling sessions, with the opportunity to attend a total of approximately 28 diet counseling sessions during the year.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1
High Protein
Caloric restriction, high protein
Weight loss with higher protein (35%) intake
Counseling
Participants will be asked to attend eight 50-minute diet counseling sessions, with the opportunity to attend a total of approximately 28 diet counseling sessions, during the year.
2
Normal Protein
Caloric restriction; normal protein
Weight loss with recommended level of protein (18%)intake
Counseling
Participants will be asked to attend eight 50-minute diet counseling sessions, with the opportunity to attend a total of approximately 28 diet counseling sessions, during the year.
Interventions
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Caloric restriction, high protein
Weight loss with higher protein (35%) intake
Caloric restriction; normal protein
Weight loss with recommended level of protein (18%)intake
Counseling
Participants will be asked to attend eight 50-minute diet counseling sessions, with the opportunity to attend a total of approximately 28 diet counseling sessions, during the year.
Eligibility Criteria
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Inclusion Criteria
* Obese or overweight
* Must live in the geographic vicinity of Rutgers University
Exclusion Criteria
* 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)
50 Years
70 Years
FEMALE
Yes
Sponsors
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National Institute on Aging (NIA)
NIH
Rutgers University
OTHER
Responsible Party
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Sue A. Shapses, Ph.D., RD
Professor
Principal Investigators
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Sue A. Shapses, PhD
Role: PRINCIPAL_INVESTIGATOR
Rutgers University, Nutritional Sciences
Locations
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Rutgers University
New Brunswick, New Jersey, United States
Countries
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References
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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.
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.
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.
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.
Sukumar D, Ambia-Sobhan H, Zurfluh R, Schlussel Y, Stahl TJ, Gordon CL, Shapses SA. Areal and volumetric bone mineral density and geometry at two levels of protein intake during caloric restriction: a randomized, controlled trial. J Bone Miner Res. 2011 Jun;26(6):1339-48. doi: 10.1002/jbmr.318.
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.
Green CO, Badaloo AV, Hsu JW, Taylor-Bryan C, Reid M, Forrester T, Jahoor F. Effects of randomized supplementation of methionine or alanine on cysteine and glutathione production during the early phase of treatment of children with edematous malnutrition. Am J Clin Nutr. 2014 May;99(5):1052-8. doi: 10.3945/ajcn.113.062729. Epub 2014 Mar 5.
Shapses SA, Sukumar D, Schneider SH, Schlussel Y, Sherrell RM, Field MP, Ambia-Sobhan H. Vitamin D supplementation and calcium absorption during caloric restriction: a randomized double-blind trial. Am J Clin Nutr. 2013 Mar;97(3):637-45. doi: 10.3945/ajcn.112.044909. Epub 2013 Jan 30.
Other Identifiers
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FP00011588
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
AG0079
Identifier Type: -
Identifier Source: org_study_id
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