Dairy Foods Compared to Dietary Supplements and Bone Health

NCT ID: NCT01394484

Last Updated: 2013-02-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-12-31
• Study Completion Date: 2013-02-28

Brief Summary

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

Detailed 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.

Conditions

Osteoporosis; Bone Loss; Osteopenia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Arm 1

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

Group Type: EXPERIMENTAL

Intervention I

Intervention Type: OTHER

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

Intervention II

Intervention Type: DIETARY_SUPPLEMENT

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

Arm 2

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

Group Type: EXPERIMENTAL

Intervention I

Intervention Type: OTHER

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

Intervention II

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

Intervention I

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

Intervention Type: OTHER

Intervention II

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

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Dairy Management Inc.

INDUSTRY

Sponsor Role: collaborator

USDA, Western Human Nutrition Research Center

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marta Van Loan, PhD

Role: PRINCIPAL_INVESTIGATOR

WHNRC, ARS, University of California Davis

Marjorie Garrod, Ph.D.

Role: STUDY_DIRECTOR

USDA, ARS, WHNRC

Locations

Western Human Nutrition Research Center

Davis, California, United States

Countries

United States

Other Identifiers

WHNRC 201018566-1

Identifier Type: -

Identifier Source: org_study_id