Dairy Foods Compared to Dietary Supplements and Bone Health

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

Detailed Description
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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.

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

Conditions
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Osteoporosis, Bone Loss, Osteopenia

Intervention / Treatment
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* Other: Intervention I
* Dietary Supplement: Intervention II


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br>Four servings of dairy foods per day for 42 days, followed by washout for 42 days, followed by dietary supplements for 42 days | Other: Intervention I<br>* Four servings of dairy foods (milk and yogurt) per day for 42 days.<br>Dietary Supplement: Intervention II<br>* 1200 mg of supplemental calcium and 400 IU of vitamin D3 for 42 days<br>|
| Experimental: Arm 2<br>Dietary Supplements for 42 days, followed by washout for 42 days, followed by 4 servings of dairy foods for 42 days. | Other: Intervention I<br>* Four servings of dairy foods (milk and yogurt) per day for 42 days.<br>Dietary Supplement: Intervention II<br>* 1200 mg of supplemental calcium and 400 IU of vitamin D3 for 42 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ratio of 41Ca/40Ca excreted in urine | 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. | 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 |