The Effect of Weight Loss and Dietary Protein Intake on Bone - Full Text View

Sponsor:	National Institute on Aging (NIA)
Collaborator:	Rutgers University
Information provided by:	National Institute on Aging (NIA)
ClinicalTrials.gov Identifier:	NCT00473031

Purpose

The purpose of this study is to learn how the amount of protein during moderate weight loss influences bone health.

Condition	Intervention
Weight Loss Bone Density	Behavioral: Caloric restriction, high protein Behavioral: Caloric restriction; normal protein Behavioral: Counseling

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Nutritional Regulation of Bone - Aim 1

Resource links provided by NLM:

MedlinePlus related topics: Diets Weight Control

U.S. FDA Resources

Further study details as provided by National Institute on Aging (NIA):

Primary Outcome Measures:

Changes in Bone density and quality [ Time Frame: one year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Changes in serum and urine bone markers, hormones, and proteins [ Time Frame: one year ] [ Designated as safety issue: No ]

Estimated Enrollment:	48
Study Start Date:	March 2007
Estimated Study Completion Date:	May 2011
Estimated Primary Completion Date:	May 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental High Protein	Behavioral: Caloric restriction, high protein Weight loss with higher protein (35%) intake Behavioral: 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: Active Comparator Normal Protein	Behavioral: Caloric restriction; normal protein Weight loss with recommended level of protein (18%)intake Behavioral: 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.

Detailed 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. Bone loss will be partially explained by changes in fat mass and estrogen levels.

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.

Eligibility

Ages Eligible for Study:	50 Years to 70 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00473031

Locations

United States, New Jersey
Rutgers University	Recruiting
New Brunswick, New Jersey, United States, 08901
Contact: Sue Shapses, PhD, RD 732-932-9403 shapses@aesop.rutgers.edu
Contact: Hasina Ambia-Sobhan 732-932-6656 togore@rci.rutgers.edu
Principal Investigator: Sue A. Shapses, PhD, RD
Sub-Investigator: Stephen Schneider, MD

Sponsors and Collaborators

National Institute on Aging (NIA)

Rutgers University

Investigators

Principal Investigator:

Sue A. Shapses, PhD, RD

Rutgers University, Nutritional Sciences

More Information

Publications:

Shapses SA, Riedt CS. Bone, body weight, and weight reduction: what are the concerns? J Nutr. 2006 Jun;136(6):1453-6. Review.

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. 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. Erratum in: Am J Clin Nutr. 2005 Jan;81(1):199.

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.

Responsible Party:	Rutgers University ( Sue Shapses, PhD, RD )
Study ID Numbers:	AG0079, RO1-AG12161
Study First Received:	May 10, 2007
Last Updated:	December 24, 2009
ClinicalTrials.gov Identifier:	NCT00473031 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Institute on Aging (NIA):

bone mass
calcium absorption
bone quality
fracture risk

Additional relevant MeSH terms:

Body Weight
Signs and Symptoms
Weight Loss
Body Weight Changes

ClinicalTrials.gov processed this record on February 08, 2010