The Effect of Severe Weight Loss and Protein Intake on Bone

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2016-01-31

Brief Summary

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The purpose of this study is to learn whether the amount of dietary protein can influence bone health during the weight loss after weight loss surgery.

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Detailed Description

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It is unclear whether the amount of protein in the diet during caloric restriction influences bone density. This information is important for determining optimal nutrient requirements during weight loss. This study will examine usual and higher dietary protein intake during severe weight loss following weight loss surgery on bone turnover, mass and quality in women, with the hypothesis that higher protein intake will reduce bone turnover and loss, and/or prevent the changes in bone quality associated with severe weight loss in women ages 18 to 70 years.

Participants will be randomly assigned to one of 2 groups: A) weight loss with recommended level of protein intake, or B) weight loss with higher protein intake. A dietitian will provide instructions for a reduced calorie, well balanced diet throughout the 12-month study using a nutrition-education behavior- modification program. Participants will have the opportunity to speak with the dietitian about their diet by phone, or on-site twice per month. In addition they will be asked to take a daily vitamin/mineral supplement and, 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).

Conditions

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Weight Loss

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

High Dietary Protein

Group Type EXPERIMENTAL

Caloric restriction, high protein

Intervention Type BEHAVIORAL

Weight loss with higher protein (35%) intake

Nutrition Education

Intervention Type BEHAVIORAL

Participants will have the opportunity to speak with the dietitian about their diet by phone, or on-site twice per month

2

Normal Dietary Protein

Group Type ACTIVE_COMPARATOR

Caloric restriction; normal protein

Intervention Type BEHAVIORAL

Weight loss with normal level of protein (18%) intake

Nutrition Education

Intervention Type BEHAVIORAL

Participants will have the opportunity to speak with the dietitian about their diet by phone, or on-site twice per month

Interventions

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Caloric restriction, high protein

Weight loss with higher protein (35%) intake

Intervention Type BEHAVIORAL

Caloric restriction; normal protein

Weight loss with normal level of protein (18%) intake

Intervention Type BEHAVIORAL

Nutrition Education

Participants will have the opportunity to speak with the dietitian about their diet by phone, or on-site twice per month

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Women ages 18 to 70 who are undergoing gastric bypass surgery
* 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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No