The Effect of Weight Loss and Dietary Protein Intake on Bone

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Sue Shapses, Rutgers University
ClinicalTrials.gov Identifier:
NCT00473031
First received: May 10, 2007
Last updated: July 2, 2012
Last verified: July 2012
  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: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Nutritional Regulation of Bone - Aim 1

Resource links provided by NLM:


Further study details as provided by Rutgers University:

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 ]

Enrollment: 48
Study Start Date: March 2007
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
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.
Active Comparator: 2
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, New Jersey
Rutgers University
New Brunswick, New Jersey, United States, 08901
Sponsors and Collaborators
Rutgers University
Investigators
Principal Investigator: Sue A. Shapses, PhD Rutgers University, Nutritional Sciences
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Sue Shapses, Professor, Rutgers University
ClinicalTrials.gov Identifier: NCT00473031     History of Changes
Other Study ID Numbers: AG0079, R01AG012161
Study First Received: May 10, 2007
Last Updated: July 2, 2012
Health Authority: United States: Federal Government

Keywords provided by Rutgers University:
bone mass
calcium absorption
bone quality
fracture risk

Additional relevant MeSH terms:
Weight Loss
Body Weight Changes
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on August 28, 2014