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

This study has been completed.
Sponsor:
Collaborator:
Dairy Management Inc.
Information provided by (Responsible Party):
USDA, Western Human Nutrition Research Center
ClinicalTrials.gov Identifier:
NCT01394484
First received: July 12, 2011
Last updated: February 25, 2013
Last verified: February 2013
  Purpose

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


Condition Intervention
Osteoporosis
Bone Loss
Osteopenia
Other: Intervention I
Dietary Supplement: Intervention II

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Milk and Yogurt vs. Calcium and Vitamin D Supplements for Bone Health of Women

Resource links provided by NLM:


Further study details as provided by USDA, Western Human Nutrition Research Center:

Primary Outcome Measures:
  • Ratio of 41Ca/40Ca excreted in urine [ 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 ] [ Designated as safety issue: No ]
    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.


Enrollment: 12
Study Start Date: December 2010
Study Completion Date: February 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   50 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01394484

Locations
United States, California
Western Human Nutrition Research Center
Davis, California, United States, 95616
Sponsors and Collaborators
USDA, Western Human Nutrition Research Center
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
  More Information

No publications provided

Responsible Party: USDA, Western Human Nutrition Research Center
ClinicalTrials.gov Identifier: NCT01394484     History of Changes
Other Study ID Numbers: WHNRC 201018566-1
Study First Received: July 12, 2011
Last Updated: February 25, 2013
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Bone Diseases, Metabolic
Osteoporosis
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on July 28, 2014