The Effect of Weight Loss and Dietary Protein Intake on Bone



Status:Completed
Conditions:Obesity Weight Loss, Orthopedic
Therapuetic Areas:Endocrinology, Orthopedics / Podiatry
Healthy:No
Age Range:50 - 70
Updated:3/14/2019
Start Date:March 2007
End Date:June 2010

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Nutritional Regulation of Bone - Aim 1

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.

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.

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)
We found this trial at
1
site
New Brunswick, New Jersey 08901
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New Brunswick, NJ
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