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The Effect of Weight Loss and Dietary Protein Intake on Bone

Primary Purpose

Weight Loss, Bone Density

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Caloric restriction, high protein
Caloric restriction; normal protein
Counseling
Sponsored by
Rutgers University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Weight Loss focused on measuring bone mass, calcium absorption, bone quality, fracture risk

Eligibility Criteria

50 Years - 70 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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)

Sites / Locations

  • Rutgers University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

High Protein

Normal Protein

Outcomes

Primary Outcome Measures

Changes in Bone density and quality

Secondary Outcome Measures

Changes in serum and urine bone markers, hormones, and proteins
Nutrient Adequacy & Diet Quality with normal & higher protein intake
healthy eating index score

Full Information

First Posted
May 10, 2007
Last Updated
April 24, 2023
Sponsor
Rutgers University
Collaborators
National Institute on Aging (NIA)
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1. Study Identification

Unique Protocol Identification Number
NCT00473031
Brief Title
The Effect of Weight Loss and Dietary Protein Intake on Bone
Official Title
Nutritional Regulation of Bone - Aim 1
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
March 2007 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
June 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rutgers University
Collaborators
National Institute on Aging (NIA)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Weight Loss, Bone Density
Keywords
bone mass, calcium absorption, bone quality, fracture risk

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
High Protein
Arm Title
2
Arm Type
Active Comparator
Arm Description
Normal Protein
Intervention Type
Behavioral
Intervention Name(s)
Caloric restriction, high protein
Intervention Description
Weight loss with higher protein (35%) intake
Intervention Type
Behavioral
Intervention Name(s)
Caloric restriction; normal protein
Intervention Description
Weight loss with recommended level of protein (18%)intake
Intervention Type
Behavioral
Intervention Name(s)
Counseling
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes in Bone density and quality
Time Frame
one year
Secondary Outcome Measure Information:
Title
Changes in serum and urine bone markers, hormones, and proteins
Time Frame
one year
Title
Nutrient Adequacy & Diet Quality with normal & higher protein intake
Description
healthy eating index score
Time Frame
one year
Other Pre-specified Outcome Measures:
Title
Glomerular Filtration Rate with two levels of protein intake
Description
GFR
Time Frame
one year

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sue A. Shapses, PhD
Organizational Affiliation
Rutgers University, Nutritional Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rutgers University
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
16702302
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.
Results Reference
background
PubMed Identifier
15746990
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.
Results Reference
background
PubMed Identifier
15213038
Citation
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.
Results Reference
background
PubMed Identifier
14742841
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.
Results Reference
background
PubMed Identifier
21611972
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 Jun;26(6):1339-48. doi: 10.1002/jbmr.318.
Results Reference
result
PubMed Identifier
35538903
Citation
Ogilvie AR, Schlussel Y, Sukumar D, Meng L, Shapses SA. Higher protein intake during caloric restriction improves diet quality and attenuates loss of lean body mass. Obesity (Silver Spring). 2022 Jul;30(7):1411-1419. doi: 10.1002/oby.23428. Epub 2022 May 11.
Results Reference
derived
PubMed Identifier
24598154
Citation
Green CO, Badaloo AV, Hsu JW, Taylor-Bryan C, Reid M, Forrester T, Jahoor F. Effects of randomized supplementation of methionine or alanine on cysteine and glutathione production during the early phase of treatment of children with edematous malnutrition. Am J Clin Nutr. 2014 May;99(5):1052-8. doi: 10.3945/ajcn.113.062729. Epub 2014 Mar 5.
Results Reference
derived
PubMed Identifier
23364004
Citation
Shapses SA, Sukumar D, Schneider SH, Schlussel Y, Sherrell RM, Field MP, Ambia-Sobhan H. Vitamin D supplementation and calcium absorption during caloric restriction: a randomized double-blind trial. Am J Clin Nutr. 2013 Mar;97(3):637-45. doi: 10.3945/ajcn.112.044909. Epub 2013 Jan 30.
Results Reference
derived

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The Effect of Weight Loss and Dietary Protein Intake on Bone

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