Los tocotrienoles y la salud ósea de las mujeres posmenopáusicas
Efecto de los tocotrienoles en la salud ósea: un estudio piloto
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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 2
- Fase 1
Contactos y Ubicaciones
Ubicaciones de estudio
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Texas
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Lubbock, Texas, Estados Unidos, 79430
- Texas Tech University Health Sciences Center
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Sin intervención: Placebo group
No active dose of tocotrienols |
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Comparador activo: Low tocotrienols group
Low dose of tocotrienols |
300 mg tocotrienols daily |
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Comparador activo: High tocotrienols group
High dose of tocotrienol |
600 mg tocotrienols daily |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Serum Bone Resorption Marker
Periodo de tiempo: baseline and 12 weeks
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The percentage change in urine N-terminal telopeptide from baseline to 12 weeks. |
baseline and 12 weeks
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Serum Bone Formation Marker
Periodo de tiempo: Baseline and 12 weeks
|
The percentage changes in serum bone specific alkaline phosphatase (BALP) from baseline to after 12 weeks. |
Baseline and 12 weeks
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Oxidative Stress Marker
Periodo de tiempo: Baseline and 12 weeks
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8-hydroxy-2'-deoxyguanosine (8-OHdG) and urinary F2-isoprostanes (also called 8-iso-PGF2α) |
Baseline and 12 weeks
|
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Liver Function Test
Periodo de tiempo: Baseline and after 12 weeks
|
serum aspartate aminotransferase (ALT) and alanine aminotransferase (AST) |
Baseline and after 12 weeks
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Quality of Life Survey
Periodo de tiempo: Baseline and 12 weeks
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SF-36 survey (v2) to assess the quality of life. |
Baseline and 12 weeks
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Serum Tocotrienols Concentrations
Periodo de tiempo: Baseline and after 12 weeks
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Serum tocotrienols concentrations in plasma. |
Baseline and after 12 weeks
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Chwan-Li (Leslie) Shen, PhD, Texas Tech University Health Sciences Center School of Medicine
Publicaciones y enlaces útiles
Publicaciones Generales
- 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.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimado)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- IRB L14-056
- American River Nutrition (Otro identificador: ARN)
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