Flaxseed Intervention on Metabolic Syndrome (FIMS)
The Effects of Flaxseed Supplement on Cardio-metabolic Risk Factors in Patients With Metabolic Syndrome
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Metabolic syndrome (MetS), a constellation of metabolic abnormalities including central obesity, dyslipidemia, elevated blood pressure and hyperglycemia, is associated with the development of type 2 diabetes and CVD. It has become one of the major public health challenges in China due to rapidly nutrition transition and the nature of obesity epidemic. Treatment of MetS in China is very important for the prevention of the epidemic of its consequences (such as CVD and type 2 diabetes).
Compelling evidence from recent human studies has demonstrated that diet and lifestyle modifications are effective means in MetS management. Flaxseed is a complex food source containing high amounts of alpha-linolenic acid (ALA) - an omega-3 fatty acid - as well as fiber, lignan precursors and other substances that may have an impact on our health. Therefore, the aim of this study is to investigate the effect of flaxseed supplementation on the management of MetS in adult Chinese men and women in a randomized, controlled clinical trial. A total of 200 participants with MetS (defined by NCEP-ATPⅢ criteria) will be randomly assigned to a flaxseed-supplemented diet (30 grams/day) or an isocaloric control diet for 12 weeks. Effects of flaxseed supplementation will be evaluated by measuring metabolic profile (BMI, blood pressure, total cholesterol, triglyceride, LDL-C and HDL-C, fasting glucose and insulin, HbA1C), inflammatory markers (CRP and IL-6), markers of endothelial function (E-selectin, ICAM-1 and VCAM-1), and fatty acid profile.
Studietype
Registrering (Faktiske)
Fase
- Fase 2
- Fase 3
Kontakter og plasseringer
Studiesteder
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-
Shanghai
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Shanghai, Shanghai, Kina, 200031
- Institute for Nutritional Sciences, Chinese Academy of Sciences
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- with metabolic syndrome Metabolic syndrome was defined based upon the updated National Cholesterol Education Program Adult Treatment Panel III criteria for Asian-Americans as presenting at least 3 of the following components: 1) waist circumference ≥ 90 cm for men or ≥ 80 cm for women; 2) triglycerides ≥1.7mmol/l; 3) HDL cholesterol <1.03 for men or <1.30 for women; 4) blood pressure ≥130/85 mmHg, or current use of antihypertentive medications; 5) fasting glucose ≥5.6mmol/l or previously diagnosed type 2 diabetes or on oral antidiabetic agents or insulin. - Being able to comply with the specified feeding conditions
- Being able to eat flaxseeds
- Being between the ages of 35 and 60 years
Exclusion Criteria:
- Pregnancy or lactation
- Use of insulin
- Severe kidney disease
- Cardiovascular diseases, stroke, cancer and psychological disorders
- Flaxseed allergies or frequently eating flaxseeds or sesame (>90 grams/week)
- Drug or alcohol abuse.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: A
healthy lifestyle counseling + 30 grams/day supplement of Flaxseed
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30 grams/day of flaxseed for 12 weeks
Health lifestyle counseling accroding to AHA reccommendation
Andre navn:
|
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Sham-komparator: B
TLC diet
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Health lifestyle counseling accroding to AHA reccommendation
Andre navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Metabolsk syndrom status
Tidsramme: 12 uker
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12 uker
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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Total cholesterol, triglyceride, HDL-C,LDL-c, fasting glucose and insulin, HbA1C, blood pressure, CRP, IL-6, adiponectin, RBP-4, E-selectin, ICAM-1, VCAM-1, and fatty acid profiles of red blood cells.
Tidsramme: 12 weeks
|
12 weeks
|
Samarbeidspartnere og etterforskere
Sponsor
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- KSCX1-YW-02
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