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

Osteoporosis Clinical Trial

Official title:

Long-term Impact of Protein on Calcium Kinetics

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00671944
• Other study ID #: 0304025163
• Status: Completed
• Phase: Phase 1
• Start date: May 2003
• Est. completion date: April 2010

Study information

• Verified date: March 2020
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: April 2010
• Est. primary completion date: October 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Osteoporosis

Intervention

Other:
• Low protein diet
Low protein diet for 6.5 weeks

Locations

Country	Name	City	State
United States	Yale New Haven Hospital Research Unit	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	United States Department of Agriculture (USDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Calcium absorption and kinetics		Baseline, day 5 and week 6
Secondary	Serum Parathyroid hormone		baseline and weekly
Secondary	Markers of bone turnover		baseline and weekly