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Tokotrienoler og beinhelse hos postmenopausale kvinner

29. september 2026 oppdatert av: Texas Tech University Health Sciences Center

Effekt av tokotrienoler på beinhelse: En pilotstudie

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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Faktiske)

89

Fase

  • Fase 2
  • Fase 1

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • Texas
      • Lubbock, Texas, Forente stater, 79430
        • Texas Tech University Health Sciences Center

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

40 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

Hunn

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Forebygging
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Dobbelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Ingen inngripen: Placebo group

No active dose of tocotrienols
Aktiv komparator: Low tocotrienols group

Low dose of tocotrienols
Legemiddel: Low tocotrienols group

300 mg tocotrienols daily
Aktiv komparator: High tocotrienols group

High dose of tocotrienol
Legemiddel: High tocotrienols group

600 mg tocotrienols daily

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Serum Bone Resorption Marker
Tidsramme: baseline and 12 weeks

The percentage change in urine N-terminal telopeptide from baseline to 12 weeks.
baseline and 12 weeks

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Serum Bone Formation Marker
Tidsramme: Baseline and 12 weeks

The percentage changes in serum bone specific alkaline phosphatase (BALP) from baseline to after 12 weeks.
Baseline and 12 weeks

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Oxidative Stress Marker
Tidsramme: 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
Tidsramme: Baseline and after 12 weeks

serum aspartate aminotransferase (ALT) and alanine aminotransferase (AST)
Baseline and after 12 weeks
Quality of Life Survey
Tidsramme: Baseline and 12 weeks

SF-36 survey (v2) to assess the quality of life.
Baseline and 12 weeks
Serum Tocotrienols Concentrations
Tidsramme: Baseline and after 12 weeks

Serum tocotrienols concentrations in plasma.
Baseline and after 12 weeks

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Texas Tech University Health Sciences Center

Samarbeidspartnere

Texas Woman's University

Etterforskere

  • Hovedetterforsker: Chwan-Li (Leslie) Shen, PhD, Texas Tech University Health Sciences Center School of Medicine

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. februar 2014

Primær fullføring (Faktiske)

1. oktober 2022

Studiet fullført (Faktiske)

1. desember 2022

Datoer for studieregistrering

Først innsendt

1. februar 2014

Først innsendt som oppfylte QC-kriteriene

6. februar 2014

Først lagt ut (Antatt)

10. februar 2014

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

30. september 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

29. september 2026

Sist bekreftet

1. september 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • IRB L14-056
  • American River Nutrition (Annen identifikator: ARN)

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