Tokotrienoly a zdraví kostí u žen po menopauze
Vliv tokotrienolů na zdraví kostí: Pilotní studie
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.
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
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.
Typ studie
Zápis (Aktuální)
Fáze
- Fáze 2
- Fáze 1
Kontakty a umístění
Studijní místa
-
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Texas
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Lubbock, Texas, Spojené státy, 79430
- Texas Tech University Health Sciences Center
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Prevence
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Dvojnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Žádný zásah: Placebo group
No active dose of tocotrienols |
|
|
Aktivní komparátor: Low tocotrienols group
Low dose of tocotrienols |
300 mg tocotrienols daily |
|
Aktivní komparátor: High tocotrienols group
High dose of tocotrienol |
600 mg tocotrienols daily |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Serum Bone Resorption Marker
Časové okno: baseline and 12 weeks
|
The percentage change in urine N-terminal telopeptide from baseline to 12 weeks. |
baseline and 12 weeks
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Serum Bone Formation Marker
Časové okno: Baseline and 12 weeks
|
The percentage changes in serum bone specific alkaline phosphatase (BALP) from baseline to after 12 weeks. |
Baseline and 12 weeks
|
Další výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Oxidative Stress Marker
Časové okno: 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
Časové okno: Baseline and after 12 weeks
|
serum aspartate aminotransferase (ALT) and alanine aminotransferase (AST) |
Baseline and after 12 weeks
|
|
Quality of Life Survey
Časové okno: Baseline and 12 weeks
|
SF-36 survey (v2) to assess the quality of life. |
Baseline and 12 weeks
|
|
Serum Tocotrienols Concentrations
Časové okno: Baseline and after 12 weeks
|
Serum tocotrienols concentrations in plasma. |
Baseline and after 12 weeks
|
Spolupracovníci a vyšetřovatelé
Spolupracovníci
Vyšetřovatelé
- Vrchní vyšetřovatel: Chwan-Li (Leslie) Shen, PhD, Texas Tech University Health Sciences Center School of Medicine
Publikace a užitečné odkazy
Obecné publikace
- 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.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhadovaný)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- IRB L14-056
- American River Nutrition (Jiný identifikátor: ARN)
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