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Completed

NCT Number: NCT01394484

Dairy Foods Compared to Dietary Supplements and Bone Health

Does the consumption of dairy foods reduce the rate of bone loss in older women more than calcium and vitamin D supplements.

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Key information

Age range

50 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Western Human Nutrition Research Center

Davis, California, 95616, United States

About this study

Research indicates that bone health is dependent on multiple nutrients, not just calcium and vitamin D, leading to the conclusion that calcium from sources that include other bone enhancing nutrients may be more effective in maintaining bone integrity than calcium and vitamin D supplements. Several studies have examined the effects of calcium intake from dairy foods on different indicators of bone health. Reducing the rate of bone loss in postmenopausal women can reduce the risk of osteoporosis related fractures. Therefore we propose to study the effectiveness of 4 servings of milk and yogurt per day for 42 days compared to calcium and vitamin D supplements for 42 days to reduce calcium loss from the skeleton in post menopausal women. Postmenopausal women, approximately 50-65 years of age, will be studied. Each volunteer will receive both interventions in a cross-over design, in random order, separated by a 42 day washout period.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Minimum 24 months since last menses
  • No hormone therapy in the past 12 months
  • Weight stable for the past 3 months
  • Bone density T score -1.7 to 0.0
  • No more than two dairy servings per day
  • No history of inflammatory disorders
  • No history of non-traumatic bone fracture
  • No supplement use or willing to discontinue
  • No lactose intolerance
  • Willing to consume milk and yogurt

Exclusion criteria

  • Less than 24 months since last menses
  • Use of hormone therapy in past yr
  • > 5 pound weight change in past 3 months
  • Osteoporosis
  • Regular >2 servings/d of dairy
  • Auto-immune/inflammatory disorders
  • History of non-traumatic bone fracture
  • Unwilling to discontinue supplements
  • Lactose intolerance
  • Unwilling to eat yogurt or drink milk

Treatment and study plan

Intervention I

Other

Four servings of dairy foods (milk and yogurt) per day for 42 days.

Intervention II

Dietary Supplement

1200 mg of supplemental calcium and 400 IU of vitamin D3 for 42 days

Primary outcomes

  1. Ratio of 41Ca/40Ca excreted in urine

    Time frame: Days 0, 90, 120, 150, 180, 187, 194, 201, 208, 215, 222, 229, 236, 243, 250, 257, 264,271, 278, 285, 292, 299, and 306 of the study

    Subjects will be asked to collect 24 hour urine samples to establish each individual's kinetic profile of Ca excretion and to measure the effectiveness of the interventions.

Sponsors and collaborators

Lead sponsor

USDA, Western Human Nutrition Research Center

Fed

Collaborators

  • Dairy Management Inc.

Registry information

Official study title

Milk and Yogurt vs. Calcium and Vitamin D Supplements for Bone Health of Women

Acronym: FL-83

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Jul 14, 2011
Registry last updated
Feb 26, 2013

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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