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The Effect of Weight Loss and Dietary Protein Intake on Bone

This study is currently recruiting participants.
Verified by National Institute on Aging (NIA), August 2008

Sponsors and Collaborators: National Institute on Aging (NIA)
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

MedlinePlus related topics:   Weight Control   

ChemIDplus related topics:   Calcium gluconate   

U.S. FDA Resources

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

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

Investigators
Principal Investigator:     Sue A. Shapses, PhD, RD     Rutgers University, Nutritional Sciences    
  More Information


Publications:

Responsible Party:   Rutgers University ( Sue Shapses, PhD, RD )
Study ID Numbers:   AG0079, RO1-AG12161
First Received:   May 10, 2007
Last Updated:   August 25, 2008
ClinicalTrials.gov Identifier:   NCT00473031
Health Authority:   United States: Federal Government

Keywords provided by National Institute on Aging (NIA):
bone mass  
calcium absorption  
bone quality  
fracture risk  

Study placed in the following topic categories:
Body Weight
Signs and Symptoms
Weight Loss
Fractures, Bone
Body Weight Changes

ClinicalTrials.gov processed this record on October 10, 2008




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