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

Primary Purpose

Osteoporosis, Bone Loss, Osteopenia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Intervention I
Intervention II
Sponsored by
USDA, Western Human Nutrition Research Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Osteoporosis

Eligibility Criteria

50 Years - 65 Years (Adult, Older Adult)FemaleAccepts 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

Sites / Locations

  • Western Human Nutrition Research Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Arm 1

Arm 2

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
July 12, 2011
Last Updated
February 25, 2013
Sponsor
USDA, Western Human Nutrition Research Center
Collaborators
Dairy Management Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01394484
Brief Title
Dairy Foods Compared to Dietary Supplements and Bone Health
Acronym
FL-83
Official Title
Milk and Yogurt vs. Calcium and Vitamin D Supplements for Bone Health of Women
Study Type
Interventional

2. Study Status

Record Verification Date
February 2013
Overall Recruitment Status
Completed
Study Start Date
December 2010 (undefined)
Primary Completion Date
February 2013 (Actual)
Study Completion Date
February 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
USDA, Western Human Nutrition Research Center
Collaborators
Dairy Management Inc.

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis, Bone Loss, Osteopenia

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1
Arm Type
Experimental
Arm Description
Four servings of dairy foods per day for 42 days, followed by washout for 42 days, followed by dietary supplements for 42 days
Arm Title
Arm 2
Arm Type
Experimental
Arm Description
Dietary Supplements for 42 days, followed by washout for 42 days, followed by 4 servings of dairy foods for 42 days.
Intervention Type
Other
Intervention Name(s)
Intervention I
Intervention Description
Four servings of dairy foods (milk and yogurt) per day for 42 days.
Intervention Type
Dietary Supplement
Intervention Name(s)
Intervention II
Intervention Description
1200 mg of supplemental calcium and 400 IU of vitamin D3 for 42 days
Primary Outcome Measure Information:
Title
Ratio of 41Ca/40Ca excreted in urine
Description
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.
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marta Van Loan, PhD
Organizational Affiliation
WHNRC, ARS, University of California Davis
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Marjorie Garrod, Ph.D.
Organizational Affiliation
USDA, ARS, WHNRC
Official's Role
Study Director
Facility Information:
Facility Name
Western Human Nutrition Research Center
City
Davis
State/Province
California
ZIP/Postal Code
95616
Country
United States

12. IPD Sharing Statement

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Dairy Foods Compared to Dietary Supplements and Bone Health

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