Long-term Nutritional Intervention Study to Determine How Protein Affects Calcium Metabolism

This study has been completed.
Sponsor:
Collaborator:
USDA Beltsville Human Nutrition Research Center
Information provided by:
Yale University
ClinicalTrials.gov Identifier:
NCT00671944
First received: May 1, 2008
Last updated: June 30, 2010
Last verified: June 2010
  Purpose

Osteoporosis is a major health problem in men and women in this country and the incidence of this disease is rising. We think that environmental factors such as nutrition may play a role in the increasing prevalence of osteoporosis. In particular, we think that a diet that is too low in protein may be contributing to bone loss. The primary purpose of this study is to compare the long-term impact of a low protein diet on measures of bone and calcium metabolism.


Condition Intervention Phase
Osteoporosis
Other: Low protein diet
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Long-term Impact of Protein on Calcium Kinetics

Resource links provided by NLM:


Further study details as provided by Yale University:

Primary Outcome Measures:
  • Calcium absorption and kinetics [ Time Frame: Baseline, day 5 and week 6 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Serum Parathyroid hormone [ Time Frame: baseline and weekly ] [ Designated as safety issue: No ]
  • Markers of bone turnover [ Time Frame: baseline and weekly ] [ Designated as safety issue: No ]

Enrollment: 11
Study Start Date: May 2003
Study Completion Date: April 2010
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Low protein diet
Other: Low protein diet
Low protein diet for 6.5 weeks

Detailed Description:

The protocol is composed of a 9.5-week study, consisting of a 3-week adjustment period followed by a 6.5-week experimental period. During the adjustment period, subjects consume a well-balanced lead-in diet designed to stabilize baseline Ca homeostasis. In the subsequent experimental period, subjects will consume the experimental diet containing 0.7 g protein/kg, 800-1200 mg phosphorus, 800 mg calcium and 2300 mg sodium. During days -6 to -1 of the adjustment diet, 5-10 and days 40-45 of the experimental period, we will measure Ca absorption and kinetics. Weekly assessments of Ca homeostasis will be done using our standard measures of calcitropic hormones, markers of bone turnover, and urine and serum minerals.

  Eligibility

Ages Eligible for Study:   20 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy Asian or Caucasian women between the ages of 20-40 years.

Exclusion Criteria:

  • Diseases or medical conditions: gastrointestinal diseases, osteoporosis, diabetes, hypertension, liver disease, thyroid disorders, kidney disease, kidney stones, cancer, heart disease, eating disorders, obesity, hypogonadism , amenorrhea, oligomenorrhea, abnormal serum FSH or estradiol levels, birth control medication, or other hormone-altering medications, pregnancy.
  • Lifestyle: smoking, excessive exercise (although moderate exercise is allowed), prescription medications known to influence vitamin D or calcium metabolism or gastric acid, excessive body weight change during the past 6 months, food allergies, unusual eating habits, or medically prescribed diets.
  • Also excluded are prisoners and individuals who are cognitively impaired.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00671944

Locations
United States, Connecticut
Yale New Haven Hospital Research Unit
New Haven, Connecticut, United States, 06510
Sponsors and Collaborators
Yale University
USDA Beltsville Human Nutrition Research Center
Investigators
Principal Investigator: Karl L Insogna, MD Yale University
  More Information

No publications provided

Responsible Party: Karl Insogna, MD, Yale University
ClinicalTrials.gov Identifier: NCT00671944     History of Changes
Other Study ID Numbers: 00-35200-9579
Study First Received: May 1, 2008
Last Updated: June 30, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Yale University:
protein
calcium
parathyroid hormone
bone markers
calcium kinetics
absorption

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

ClinicalTrials.gov processed this record on August 28, 2014