A Dietary Strategy to maximize Bone Mass in United States Naval Academy Midshipmen
Abstract
The study evaluates the efficacy and safety of two different types of dietary interventions to promote gain in bone mass at several skeletal sites and changes in hormonal or bone marker levels indicative of bone accretion in young Naval Academy Midshipmen. The dietary interventions optimize different nutritional factors, not just calcium intake, and enable us to examine the effect of maximizing all the nutrients essential for both bone matrix formation and bone mineralization under conditions of usual dietary intake at the Naval Academy. The supplementation trial was initiated in March 2000 in 161 Midshipmen from the classes of 2002 and 2003 who under went all required baseline-screening procedures. After sampling the supplements, these 161 Midshipmen agreed to participate for the two-year duration. The Midshipmen were randomized according to BMI and gender to one of four different dietary groups, each of which consume a unique combination of calcium supplement or placebo, and either a fortified protein bar or its placebo. The supplements are to be consumed every day for the study duration. After six months of taking the supplements, 78 Midshipmen remain in the study and 25 of the remaining participants are women. Six-month blood, urine and dietary records are currently being collected. Many of the baseline parameters have been analyzed and some will be analyzed with the six -month collections. Despite the very high rate of attrition, the four group sizes remain similar with 18 to 20 subjects per group. We have also persuaded 25 subjects, who dropped out because they no longer wanted to take the supplements, to continue in the study as sentinels. By providing bone, blood and dietary information, they will allow us to compare the supplemented and placebo groups to those consuming the usual Naval Academy diet.
Document Details
- Document Type
- Technical Report
- Publication Date
- Oct 01, 2000
- Accession Number
- ADA396179
Entities
People
- Mona S. Calvo
Organizations
- Food and Drug Administration