Tocotrienols and Bone Health of Postmenopausal Women

Phase 1

Completed

• Conditions: Osteoporosis
• Interventions: Drug: Low tocotrienols group; Drug: High tocotrienols group

• Registration Number: NCT02058420
• Lead Sponsor: Texas Tech University Health Sciences Center

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-02
• Study First Submitted: 2014-02-01
• Study First Submitted QC: 2014-02-06
• Study First Posted: 2014-02-10
• Primary Completion: 2022-10
• Study Completion: 2022-12
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-17
• Last Update Posted: 2023-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 78

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low tocotrienols group	Low tocotrienols group	Low dose of tocotrienols
High tocotrienols group	High tocotrienols group	High dose of tocotrienol

Primary Outcome Measures

Name	Time	Method
Serum bone resorption marker	baseline and after 12 weeks	serum C-terminal cross-linked telopeptide of type I collagen, CTX Change from baseline CTX at 12 weeks. Investigators will also assess change from baseline CTX at 6 weeks.

Secondary Outcome Measures

Name	Time	Method
Serum bone formation marker	baseline, after 6 weeks, after 12 weeks	serum N-terminal propeptide of type I collagen, PINP

Trial Locations

Locations (1)

Texas Tech University Health Sciences Center; 🇺🇸 Lubbock, Texas, United States