Tocotrienols and Bone Health of Postmenopausal Women

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

78 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-28

Study Completion Date

2022-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Osteoporosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Placebo group

No active dose of tocotrienols

Group Type NO_INTERVENTION

No interventions assigned to this group

Low tocotrienols group

Low dose of tocotrienols

Group Type ACTIVE_COMPARATOR

Low tocotrienols group

Intervention Type DRUG

300 mg tocotrienols daily

High tocotrienols group

High dose of tocotrienol

Group Type ACTIVE_COMPARATOR

High tocotrienols group

Intervention Type DRUG

600 mg tocotrienols daily

Interventions

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Low tocotrienols group

300 mg tocotrienols daily

Intervention Type DRUG

High tocotrienols group

600 mg tocotrienols daily

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes