Long-term Nutritional Intervention Study to Determine How Protein Affects Calcium Metabolism
Long-term Impact of Protein on Calcium Kinetics
1 other identifier
interventional
11
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started May 2003
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2003
CompletedFirst Submitted
Initial submission to the registry
May 1, 2008
CompletedFirst Posted
Study publicly available on registry
May 5, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2010
CompletedMarch 31, 2020
March 1, 2020
6.4 years
May 1, 2008
March 30, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Calcium absorption and kinetics
Baseline, day 5 and week 6
Secondary Outcomes (2)
Serum Parathyroid hormone
baseline and weekly
Markers of bone turnover
baseline and weekly
Study Arms (1)
1
EXPERIMENTALLow protein diet
Interventions
Eligibility Criteria
You may qualify if:
- Healthy Asian or Caucasian women between the ages of 20-40 years.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Yale Universitylead
- United States Department of Agriculture (USDA)collaborator
Study Sites (1)
Yale New Haven Hospital Research Unit
New Haven, Connecticut, 06510, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Karl L Insogna, MD
Yale University
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
May 1, 2008
First Posted
May 5, 2008
Study Start
May 1, 2003
Primary Completion
October 1, 2009
Study Completion
April 1, 2010
Last Updated
March 31, 2020
Record last verified: 2020-03