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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00473031
Other study ID # AG0079
Secondary ID R01AG012161FP000
Status Completed
Phase N/A
First received
Last updated
Start date March 2007
Est. completion date June 2010

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 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.


Description:

It is unclear whether protein intake during dieting influences bone density. This information is important for determining optimal nutrient requirements during weight loss. This study will compare the effects of weight loss with a lower-carbohydrate, high-protein (HP) diet to a high-carbohydrate, moderate protein (HC) diet on bone mass and quality in postmenopausal women (ages 50-70 years) with the hypothesis that bone turnover and loss of bone will be reduced on the HP compared to the HC weight loss diet. In a secondary aim, we will examine bone markers, hormones and the impact of protein intake on diet quality. 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.


Recruitment information / eligibility

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)

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
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.

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

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

Outcome

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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