NCT00473031

The Effect of Weight Loss and Dietary Protein Intake on Bone

Nutritional Regulation of Bone - Aim 1

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Rutgers University · Academic / Other
• Sex: Female
• Age: 50 Years – 70 Years
• Healthy volunteers: Accepted

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.

Conditions

• Weight Loss
• Bone Density

Interventions

Type	Name	Description
BEHAVIORAL	Caloric restriction, high protein	Weight loss with higher protein (35%) intake
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.

Timeline

• Start date: 2007-03-01
• Primary completion: 2010-06-01
• Completion: 2010-06-01
• First posted: 2007-05-14
• Last updated: 2023-04-26

Locations

1 site across 1 country: United States