Dairy Foods Compared to Dietary Supplements and Bone Health (FL-83)

USDA, Western Human Nutrition Research Center

Status: Completed

Conditions: Osteopenia; Osteoporosis; Bone Loss

Treatments: Dietary Supplement: Intervention II; Other: Intervention I

Study type: Interventional

Funder types: Other U.S. Federal agency; Industry

Identifiers

NCT01394484

WHNRC 201018566-1

Details and patient eligibility

About

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

Full description

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.

Enrollment: 12 patients

Sex: Female

Ages: 50 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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12 participants in 2 patient groups

Arm 1

Experimental group

Description:

Four servings of dairy foods per day for 42 days, followed by washout for 42 days, followed by dietary supplements for 42 days

Treatment:

Dietary Supplement: Intervention II

Other: Intervention I

Arm 2

Experimental group

Description:

Dietary Supplements for 42 days, followed by washout for 42 days, followed by 4 servings of dairy foods for 42 days.

Treatment:

Dietary Supplement: Intervention II

Other: Intervention I