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Tocotrienols and Bone Health of Postmenopausal Women

Primary Purpose

Osteoporosis

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Low tocotrienols group

High tocotrienols group

About this trial

This is an interventional prevention trial for Osteoporosis focused on measuring bone health

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion criteria

Postmenopausal women with no menses for 1-10 years.
Bone mass with bone mineral density (BMD) T-score between 0.5 and -2.5 at the spine and/or hip.
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%.
Serum 25-OH vitamin D >= 20 ng/mL.
Age 40 and older

Exclusion criteria

History of, or evidence for, metabolic bone disease including recent fractures (other than low BMD).
Having received medication (calcitonin, raloxifene, or systemic glucocorticoids) within 3 months before the start of the study.
Having bisphosphonate within 12 months before the start of the study.
Having hormone/hormone-like replacement therapy within 3 months before the initiation of the study.
History of cancer except for treated superficial basal or squamous cell carcinoma of the skin.
History or evidence of endocrine disease or malabsorption syndrome that would be a contraindication to the investigation of tocotrienols' absorption.
Uncontrolled diabetes mellitus defined by an HbA1c of ≥ 7% in the last 3 months.
History of statin or other drug for cholesterol-control within 3 months before the start of the study.
Alcohol intake greater than "moderate" (one drink per day) or use of nonsteroidal anti-inflammatory drugs on a regular basis.
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.
Smoking > 10 cigarettes/day.
Unwilling to accept randomization.

Sites / Locations

Texas Tech University Health Sciences Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Active Comparator

Arm Label

Placebo group

Low tocotrienols group

High tocotrienols group

Arm Description

No active dose of tocotrienols

Low dose of tocotrienols

High dose of tocotrienol

Outcomes

Primary Outcome Measures

Serum bone resorption marker

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

Serum bone formation marker

serum N-terminal propeptide of type I collagen, PINP

Full Information

NCT ID

NCT02058420

First Posted

February 1, 2014

Last Updated

February 17, 2023

Sponsor

Texas Tech University Health Sciences Center

Collaborators

Texas Woman's University

1. Study Identification

Unique Protocol Identification Number

NCT02058420

Brief Title

Tocotrienols and Bone Health of Postmenopausal Women

Official Title

Effect of Tocotrienols on Bone Health: A Pilot Study

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Completed

Study Start Date

February 2014 (Actual)

Primary Completion Date

October 2022 (Actual)

Study Completion Date

December 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Texas Tech University Health Sciences Center

Collaborators

Texas Woman's University

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Osteoporosis

Keywords

bone health

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

78 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo group

Arm Type

No Intervention

Arm Description

No active dose of tocotrienols

Arm Title

Low tocotrienols group

Arm Type

Active Comparator

Arm Description

Low dose of tocotrienols

Arm Title

High tocotrienols group

Arm Type

Active Comparator

Arm Description

High dose of tocotrienol

Intervention Type

Drug

Intervention Name(s)

Low tocotrienols group

Intervention Description

300 mg tocotrienols daily

Intervention Type

Drug

Intervention Name(s)

High tocotrienols group

Intervention Description

600 mg tocotrienols daily

Primary Outcome Measure Information:

Title

Serum bone resorption marker

Description

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.

Time Frame

baseline and after 12 weeks

Secondary Outcome Measure Information:

Title

Serum bone formation marker

Description

serum N-terminal propeptide of type I collagen, PINP

Time Frame

baseline, after 6 weeks, after 12 weeks

Other Pre-specified Outcome Measures:

Title

Oxidative stress marker

Description

8-hydroxy-2'-deoxyguanosine (8-OHdG) and urinary F2-isoprostanes (also called 8-iso-PGF2α)

Time Frame

baseline, after 6 weeks, after 12 weeks

Title

Liver function test

Description

serum aspartate aminotransferase (ALT) and alanine aminotransferase (AST)

Time Frame

baseline, after 6 weeks, after 12 weeks

Title

Quality of life Survey

Description

SF-36 survey (v2)

Time Frame

baseline, after 6 weeks, after 12 weeks

Title

Serum tocotrienols concentrations

Time Frame

baseline, after 6 weeks, after 12 weeks

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion criteria Postmenopausal women with no menses for 1-10 years. Bone mass with bone mineral density (BMD) T-score between 0.5 and -2.5 at the spine and/or hip. 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%. Serum 25-OH vitamin D >= 20 ng/mL. Age 40 and older Exclusion criteria History of, or evidence for, metabolic bone disease including recent fractures (other than low BMD). Having received medication (calcitonin, raloxifene, or systemic glucocorticoids) within 3 months before the start of the study. Having bisphosphonate within 12 months before the start of the study. Having hormone/hormone-like replacement therapy within 3 months before the initiation of the study. History of cancer except for treated superficial basal or squamous cell carcinoma of the skin. History or evidence of endocrine disease or malabsorption syndrome that would be a contraindication to the investigation of tocotrienols' absorption. Uncontrolled diabetes mellitus defined by an HbA1c of ≥ 7% in the last 3 months. History of statin or other drug for cholesterol-control within 3 months before the start of the study. Alcohol intake greater than "moderate" (one drink per day) or use of nonsteroidal anti-inflammatory drugs on a regular basis. 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. Smoking > 10 cigarettes/day. Unwilling to accept randomization.

Facility Information:

Facility Name

Texas Tech University Health Sciences Center

City

Lubbock

State/Province

Texas

ZIP/Postal Code

79430

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

29954374

Citation

Shen CL, Wang S, Yang S, Tomison MD, Abbasi M, Hao L, Scott S, Khan MS, Romero AW, Felton CK, Mo H. A 12-week evaluation of annatto tocotrienol supplementation for postmenopausal women: safety, quality of life, body composition, physical activity, and nutrient intake. BMC Complement Altern Med. 2018 Jun 28;18(1):198. doi: 10.1186/s12906-018-2263-0.

Results Reference

derived

PubMed Identifier

29330573

Citation

Shen CL, Yang S, Tomison MD, Romero AW, Felton CK, Mo H. Tocotrienol supplementation suppressed bone resorption and oxidative stress in postmenopausal osteopenic women: a 12-week randomized double-blinded placebo-controlled trial. Osteoporos Int. 2018 Apr;29(4):881-891. doi: 10.1007/s00198-017-4356-x. Epub 2018 Jan 12.

Results Reference

derived

PubMed Identifier

28011809

Citation

Shen CL, Mo H, Yang S, Wang S, Felton CK, Tomison MD, Soelaiman IN. Safety and efficacy of tocotrienol supplementation for bone health in postmenopausal women: protocol for a dose-response double-blinded placebo-controlled randomised trial. BMJ Open. 2016 Dec 23;6(12):e012572. doi: 10.1136/bmjopen-2016-012572.

Results Reference

derived

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Tocotrienols and Bone Health of Postmenopausal Women

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