Back to resultsLong-term Nutritional Intervention Study to Determine How Protein Affects Calcium Metabolism
Primary Purpose
Osteoporosis
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Low protein diet
Sponsored by
About this trial
This is an interventional treatment trial for Osteoporosis focused on measuring protein, calcium, parathyroid hormone, bone markers, calcium kinetics, absorption
Eligibility 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.
Sites / Locations
- Yale New Haven Hospital Research Unit
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
Low protein diet
Outcomes
Primary Outcome Measures
Calcium absorption and kinetics
Secondary Outcome Measures
Serum Parathyroid hormone
Markers of bone turnover
Full Information
NCT ID
NCT00671944
First Posted
May 1, 2008
Last Updated
March 30, 2020
Sponsor
Yale University
Collaborators
United States Department of Agriculture (USDA)
1. Study Identification
Unique Protocol Identification Number
NCT00671944
Brief Title
Long-term Nutritional Intervention Study to Determine How Protein Affects Calcium Metabolism
Official Title
Long-term Impact of Protein on Calcium Kinetics
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
May 2003 (undefined)
Primary Completion Date
October 2009 (Actual)
Study Completion Date
April 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Yale University
Collaborators
United States Department of Agriculture (USDA)
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis
Keywords
protein, calcium, parathyroid hormone, bone markers, calcium kinetics, absorption
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
11 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Low protein diet
Intervention Type
Other
Intervention Name(s)
Low protein diet
Intervention Description
Low protein diet for 6.5 weeks
Primary Outcome Measure Information:
Title
Calcium absorption and kinetics
Time Frame
Baseline, day 5 and week 6
Secondary Outcome Measure Information:
Title
Serum Parathyroid hormone
Time Frame
baseline and weekly
Title
Markers of bone turnover
Time Frame
baseline and weekly
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karl L Insogna, MD
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yale New Haven Hospital Research Unit
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Long-term Nutritional Intervention Study to Determine How Protein Affects Calcium Metabolism
We'll reach out to this number within 24 hrs