Tocotrienols and Bone Health of Postmenopausal Women
Status:
Active, not recruiting
Trial end date:
2022-12-01
Target enrollment:
Participant gender:
Summary
Osteoporosis (severe bone loss) is a bone disease with bone fragility and an increased chance
for bone fractures. Women are 4 times more likely to have osteoporosis than men because there
is no estrogen protection after menopause and women in general have lighter and thinner
bones. Recent studies have indicated tocotrienols (one kind of vitamin E) supplement may be
good for the bone health in postmenopausal women. However, no study has ever been done the
role of tocotrienols in bone health in postmenopausal women. Our long-term goal is to develop
a new strategy featuring a dietary supplement (i.e., tocotrienols) for slowing down bone loss
in postmenopausal women. The purpose of the study is to examine the effect of 12-week
tocotrienols on bone measurements in postmenopausal women. Investigators plan to recruit
postmenopausal women using flyers, non-solicited e-mail system, campus announcement, local
radio, newspapers, and TV scripts. We plan to enroll approximately 200 women to obtain 78
qualified women at the start of the study. After screening, qualified participants will be
matched by body weight and age, and then randomly assigned to no tocotrienols, low
tocotrienols, or high tocotrienols group. The outcome measures will be assessed at baseline,
after 6, and after 12 weeks. Bone-related measurements will be recorded using blood and urine
samples. Investigators will monitor safety of subjects after 6 and after 12 weeks. Food
intake, physical activity, and quality of life will be assessed at baseline and 12 weeks. All
data will be analyzed statistically.