We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01394484
Recruitment Status : Completed
First Posted : July 14, 2011
Last Update Posted : February 26, 2013
Sponsor:
Collaborator:
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment
Osteoporosis Bone Loss Osteopenia 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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Milk and Yogurt vs. Calcium and Vitamin D Supplements for Bone Health of Women
Study Start Date : December 2010
Primary Completion Date : February 2013
Study Completion Date : February 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

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


Outcome Measures

Primary Outcome Measures :
  1. 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 ]
    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.


Eligibility Criteria

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   50 Years to 65 Years   (Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: USDA, Western Human Nutrition Research Center
ClinicalTrials.gov Identifier: NCT01394484     History of Changes
Other Study ID Numbers: WHNRC 201018566-1
First Posted: July 14, 2011    Key Record Dates
Last Update Posted: February 26, 2013
Last Verified: February 2013

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