폐경기 여성의 토코트리에놀과 뼈 건강
뼈 건강에 대한 토코트리에놀의 효과: 파일럿 연구
Osteoporosis (severe bone loss) is a bone disease with bone fragility and an increased chance for bone fractures. 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. We examined the effects of 12-week tocotrienols supplemenation on bone measurements in postmenopausal women. We plan to enroll approximately 200 women to recruit 78 qualified women into 3 groups: no tocotrienols, low tocotrienols, or high tocotrienols group. The outcome measures will be assessed at baseline, after 6 weeks, and after 12 weeks. Bone-related measurements will be recorded using blood and urine samples. Investigators will monitor the 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.
연구 개요
상세 설명
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, aiming to recruit 78 qualified women at the study's outset. After screening, qualified participants will be matched by body weight and age, and then randomly assigned to the no tocotrienols, low tocotrienols, or high tocotrienols group. The outcome measures will be assessed at baseline, after 6 weeks, and after 12 weeks. Bone-related measurements will be recorded using blood and urine samples. Investigators will monitor the 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.
연구 유형
등록 (실제)
단계
- 2 단계
- 1단계
연락처 및 위치
연구 장소
-
-
Texas
-
Lubbock, Texas, 미국, 79430
- Texas Tech University Health Sciences Center
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
간섭 없음: Placebo group
No active dose of tocotrienols |
|
|
활성 비교기: Low tocotrienols group
Low dose of tocotrienols |
300 mg tocotrienols daily |
|
활성 비교기: High tocotrienols group
High dose of tocotrienol |
600 mg tocotrienols daily |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Serum Bone Resorption Marker
기간: baseline and 12 weeks
|
The percentage change in urine N-terminal telopeptide from baseline to 12 weeks. |
baseline and 12 weeks
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Serum Bone Formation Marker
기간: Baseline and 12 weeks
|
The percentage changes in serum bone specific alkaline phosphatase (BALP) from baseline to after 12 weeks. |
Baseline and 12 weeks
|
기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Oxidative Stress Marker
기간: Baseline and 12 weeks
|
8-hydroxy-2'-deoxyguanosine (8-OHdG) and urinary F2-isoprostanes (also called 8-iso-PGF2α) |
Baseline and 12 weeks
|
|
Liver Function Test
기간: Baseline and after 12 weeks
|
serum aspartate aminotransferase (ALT) and alanine aminotransferase (AST) |
Baseline and after 12 weeks
|
|
Quality of Life Survey
기간: Baseline and 12 weeks
|
SF-36 survey (v2) to assess the quality of life. |
Baseline and 12 weeks
|
|
Serum Tocotrienols Concentrations
기간: Baseline and after 12 weeks
|
Serum tocotrienols concentrations in plasma. |
Baseline and after 12 weeks
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Chwan-Li (Leslie) Shen, PhD, Texas Tech University Health Sciences Center School of Medicine
간행물 및 유용한 링크
일반 간행물
- Shen CL, Mo H, Dunn DM, Watkins BA. Tocotrienol Supplementation Led to Higher Serum Levels of Lysophospholipids but Lower Acylcarnitines in Postmenopausal Women: A Randomized Double-Blinded Placebo-Controlled Clinical Trial. Front Nutr. 2021 Dec 24;8:766711. doi: 10.3389/fnut.2021.766711. eCollection 2021.
- 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.
- 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.
- 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.
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정된)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .