Tocotrienols and Bone Health of Postmenopausal Women
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Osteoporosis |
| Therapuetic Areas: | Rheumatology |
| Healthy: | No |
| Age Range: | 40 - Any |
| Updated: | 1/10/2019 |
| Start Date: | February 2014 |
| End Date: | December 2019 |
Effect of Tocotrienols on Bone Health: A Pilot Study
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.
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.
Inclusion criteria
1. Postmenopausal women with no menses for 1-10 years.
2. Bone mass with bone mineral density (BMD) T-score between 0.5 and -2.5 at the spine
and/or hip.
3. Normal laboratory evaluation, thyroid function: TSH > 0.3 and < 5.0 mU/L; hepatic
function: bilirubin ≤ 2.0 mg/dl; SGOT (also called AST)/SGPT (also called ALT) < 3x
upper limit of normal; renal function: serum creatinine ≤ 2.0 mg/dl; BUN less than 1.5
times upper limit of normal; serum calcium, phosphorus, and alkaline phosphatase:
within normal ranges. HbA1c < 7.0%.
4. Serum 25-OH vitamin D >= 20 ng/mL.
5. Age 40 and older
Exclusion criteria
1. History of, or evidence for, metabolic bone disease including recent fractures (other
than low BMD).
2. Having received medication (calcitonin, raloxifene, or systemic glucocorticoids)
within 3 months before the start of the study.
3. Having bisphosphonate within 12 months before the start of the study.
4. Having hormone/hormone-like replacement therapy within 3 months before the initiation
of the study.
5. History of cancer except for treated superficial basal or squamous cell carcinoma of
the skin.
6. History or evidence of endocrine disease or malabsorption syndrome that would be a
contraindication to the investigation of tocotrienols' absorption.
7. Uncontrolled diabetes mellitus defined by an HbA1c of ≥ 7% in the last 3 months.
8. History of statin or other drug for cholesterol-control within 3 months before the
start of the study.
9. Alcohol intake greater than "moderate" (one drink per day) or use of nonsteroidal
anti-inflammatory drugs on a regular basis.
10. Cognitive impairment, depression or other medical/eating disorders, likely to move
during the trial, lack of transportation, distance from the study site, or unavailable
at sample collection times.
11. Smoking > 10 cigarettes/day.
12. Unwilling to accept randomization.
We found this trial at
1
site
Lubbock, Texas 79430
Principal Investigator: Chwan-Li (Leslie) Shen, PhD
Phone: 806-743-2815
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