Weight Loss Clinical Trial
Official title:
Nutritional Regulation of Bone - Aim 1
Verified date | January 2022 |
Source | Rutgers, The State University of New Jersey |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to learn how the amount of protein during moderate weight loss influences bone health. We will also examine how two levels of protein intake affects diet quality.
Status | Completed |
Enrollment | 60 |
Est. completion date | June 2010 |
Est. primary completion date | June 2010 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 50 Years to 70 Years |
Eligibility | Inclusion Criteria: - Postmenopausal women who are more than 2 years since last menses - 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) |
Country | Name | City | State |
---|---|---|---|
United States | Rutgers University | New Brunswick | New Jersey |
Lead Sponsor | Collaborator |
---|---|
Rutgers University | National Institute on Aging (NIA) |
United States,
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
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
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 J — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Glomerular Filtration Rate with two levels of protein intake | GFR | one year | |
Primary | Changes in Bone density and quality | one year | ||
Secondary | Changes in serum and urine bone markers, hormones, and proteins | one year | ||
Secondary | Nutrient Adequacy & Diet Quality with normal & higher protein intake | healthy eating index score | one year |
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