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Completed

NCT Number: NCT00473031

The Effect of Weight Loss and Dietary Protein Intake on Bone

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.

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Key information

Age range

50 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Rutgers University

New Brunswick, New Jersey, 08901, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Caloric restriction, high protein

Behavioral

Weight loss with higher protein (35%) intake

Caloric restriction; normal protein

Behavioral

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

Counseling

Behavioral

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 outcomes

  1. Changes in Bone density and quality

    Time frame: one year

Secondary outcomes

  1. Changes in serum and urine bone markers, hormones, and proteins

    Time frame: one year

  2. Nutrient Adequacy & Diet Quality with normal & higher protein intake

    Time frame: one year

    healthy eating index score

Other outcomes

  1. Glomerular Filtration Rate with two levels of protein intake

    Time frame: one year

    GFR

Sponsors and collaborators

Lead sponsor

Rutgers University

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Official study title

Nutritional Regulation of Bone - Aim 1

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
May 14, 2007
Registry last updated
May 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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