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

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

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

Study Overview

• Status: Completed
• Conditions: Osteoporosis; Bone Loss; Osteopenia
• Intervention / Treatment: Other: Intervention I; Dietary supplement: Intervention II

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.

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Davis, California, United States, 95616
      • Western Human Nutrition Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Other: Intervention I; Four servings of dairy foods (milk and yogurt) per day for 42 days.; Dietary supplement: Intervention II; 1200 mg of supplemental calcium and 400 IU of vitamin D3 for 42 days
Experimental: Arm 2; Dietary Supplements for 42 days, followed by washout for 42 days, followed by 4 servings of dairy foods for 42 days.	Other: Intervention I; Four servings of dairy foods (milk and yogurt) per day for 42 days.; Dietary supplement: Intervention II; 1200 mg of supplemental calcium and 400 IU of vitamin D3 for 42 days

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: USDA, Western Human Nutrition Research Center
• Collaborators: Dairy Management Inc.
• Investigators: Principal Investigator: Marta Van Loan, PhD, WHNRC, ARS, University of California Davis; Study Director: Marjorie Garrod, Ph.D., USDA, ARS, WHNRC

Study record dates

Study Major Dates

• Study Start: December 1, 2010
• Primary Completion (Actual): February 1, 2013
• Study Completion (Actual): February 1, 2013

Study Registration Dates

• First Submitted: July 12, 2011
• First Submitted That Met QC Criteria: July 12, 2011
• First Posted (Estimate): July 14, 2011

Study Record Updates

• Last Update Posted (Estimate): February 26, 2013
• Last Update Submitted That Met QC Criteria: February 25, 2013
• Last Verified: February 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Musculoskeletal Diseases; Bone Diseases; Osteoporosis; Bone Diseases, Metabolic
• Other Study ID Numbers: WHNRC 201018566-1