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

Phase 1

Completed

• Conditions: Osteoporosis
• Interventions: Other: Low protein diet

• Registration Number: NCT00671944
• Lead Sponsor: Yale University

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.

Study Timeline

• Study Start: 2003-05
• Study First Submitted: 2008-05-01
• Study First Submitted QC: 2008-05-01
• Study First Posted: 2008-05-05
• Primary Completion: 2009-10
• Study Completion: 2010-04
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-30
• Last Update Posted: 2020-03-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 11

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Low protein diet	Low protein diet

Primary Outcome Measures

Name	Time	Method
Calcium absorption and kinetics	Baseline, day 5 and week 6

Secondary Outcome Measures

Name	Time	Method
Serum Parathyroid hormone	baseline and weekly
Markers of bone turnover	baseline and weekly

Trial Locations

Locations (1)

Yale New Haven Hospital Research Unit; 🇺🇸 New Haven, Connecticut, United States