The Effect of Weight Loss and Dietary Protein Intake on Bone

Not Applicable

Completed

• Conditions: Weight Loss; Bone Density
• Interventions: Behavioral: Caloric restriction, high protein; Behavioral: Caloric restriction; normal protein; Behavioral: Counseling

• Registration Number: NCT00473031
• Lead Sponsor: Rutgers University

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.

Study Timeline

• Study Start: 2007-03
• Study First Submitted: 2007-05-10
• Study First Submitted QC: 2007-05-10
• Study First Posted: 2007-05-14
• Primary Completion: 2010-06
• Study Completion: 2010-06
• Status Verified: 2022-01
• Last Update Submitted: 2023-04-24
• Last Update Posted: 2023-04-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 60

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Caloric restriction, high protein	High Protein
2	Caloric restriction; normal protein	Normal Protein
1	Counseling	High Protein
2	Counseling	Normal Protein

Primary Outcome Measures

Name	Time	Method
Changes in Bone density and quality	one year

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Rutgers University; 🇺🇸 New Brunswick, New Jersey, United States