Dairy Foods Compared to Dietary Supplements and Bone Health

USDA, Western Human Nutrition Research Center12 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Osteoporosis Bone Loss Osteopenia

Interventions

Intervention IOTHER

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

Intervention IIDIETARY_SUPPLEMENT

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

Eligibility

Sex: FEMALEMin age: 50 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Western Human Nutrition Research Center

Davis, California, United States

Outcomes

Primary Outcomes

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.

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

Data from ClinicalTrials.gov

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