Clinical trial NCT02058420: Tocotrienols and Bone Health of Postmenopausal Women
Official title: Effect of Tocotrienols on Bone Health: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Osteoporosis
Keywords: bone health
Lead sponsor: Texas Tech University Health Sciences Center
Sponsor class: OTHER
Collaborators: name: Texas Woman's University
First posted: 2014-02-10
Enrollment: 78
Sex: FEMALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Serum bone resorption marker
timeFrame: baseline and after 12 weeks
Secondary outcomes:
measure: Serum bone formation marker
timeFrame: baseline, after 6 weeks, after 12 weeks
Other outcomes:
measure: Oxidative stress marker
timeFrame: baseline, after 6 weeks, after 12 weeks
measure: Liver function test
timeFrame: baseline, after 6 weeks, after 12 weeks
measure: Quality of life Survey
timeFrame: baseline, after 6 weeks, after 12 weeks
measure: Serum tocotrienols concentrations
timeFrame: baseline, after 6 weeks, after 12 weeks
Locations:
city: Lubbock
country: United States
facility: Texas Tech University Health Sciences Center
state: Texas
Study officials:
References:
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.
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.
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.