Tocotrienols and Bone Health of Postmenopausal Women

Osteoporosis Clinical Trial

Official title:

Effect of Tocotrienols on Bone Health: A Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02058420
• Other study ID #: IRB L14-056
• Secondary ID: American River N
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: February 2014
• Est. completion date: December 2022

Study information

• Verified date: February 2023
• Source: Texas Tech University Health Sciences Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: December 2022
• Est. primary completion date: October 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 40 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Osteoporosis

Intervention

Drug:
• Low tocotrienols group
300 mg tocotrienols daily
• High tocotrienols group
600 mg tocotrienols daily

Locations

Country	Name	City	State
United States	Texas Tech University Health Sciences Center	Lubbock	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Texas Tech University Health Sciences Center	Texas Woman's University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Oxidative stress marker	8-hydroxy-2'-deoxyguanosine (8-OHdG) and urinary F2-isoprostanes (also called 8-iso-PGF2a)	baseline, after 6 weeks, after 12 weeks
Other	Liver function test	serum aspartate aminotransferase (ALT) and alanine aminotransferase (AST)	baseline, after 6 weeks, after 12 weeks
Other	Quality of life Survey	SF-36 survey (v2)	baseline, after 6 weeks, after 12 weeks
Other	Serum tocotrienols concentrations		baseline, after 6 weeks, after 12 weeks
Primary	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.	baseline and after 12 weeks
Secondary	Serum bone formation marker	serum N-terminal propeptide of type I collagen, PINP	baseline, after 6 weeks, after 12 weeks