Effects of the Mediterranean Diet on Cardiovascular Risk Profile in Men and Women (ALIMED)
5. oktober 2011 oppdatert av: Simone Lemieux, Laval University
Gender Differences in Response to the Mediterranean Diet
The purpose of this study is to document differences between men and women in changes in metabolic variables associated with cardiovascular risk in response to a 4 weeks isocaloric controlled nutritional intervention based on the Mediterranean diet in which all foods and drinks are provided to subjects.
The investigators hypothesize that the decrease in LDL-cholesterol will be more important in men than in women.
Studieoversikt
Status
Fullført
Forhold
Detaljert beskrivelse
Nutritional interventions promoting the adoption of the traditional Mediterranean diet (MedDiet) are known to have significant and beneficial effects on cardiovascular disease (CVD) risk profile.
On the other hand, recent evidence suggests that women respond differently to diet than men.
No study has yet compared men and women metabolic response to the MedDiet in a controlled metabolic context in which all foods and drinks consumed are provided to the participant prepared by the research team.
Therefore, we do not know whether being fed a MedDiet in controlled conditions would have similar health benefits in men and women.
The purpose of this study is to document differences between men and women in changes in metabolic variables associated with cardiovascular risk in response to a 4 weeks isocaloric controlled nutritional intervention based on the MedDiet in which all foods and drinks are provided to subjects.
We hypothesize that the decrease in LDL-cholesterol will be more important in men than in women.
In this parallel controlled trial, both men and women are assigned to the same 4 weeks experimental diet formulated to be concordant with characteristics of the traditional MedDiet.
Data will be collected before and after the controlled nutritional intervention based on the MedDiet.
Studietype
Intervensjonell
Registrering (Faktiske)
70
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Quebec, Canada, G1V0A6
- Institute of Nutraceuticals and Functional Foods (INAF), Laval University
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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
25 år til 50 år (Voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- Men and premenopausal women from de Quebec City metropolitan area.
- Slightly elevated LDL-cholesterol concentrations (3.4-4.9 mM) or total cholesterol to HDL-C ratio ≥ 5.0
- At least one of the four following factors of the metabolic syndrome: 1) waist circumference > 94 cm in men and > 80 cm in women; 2) TG > 1.7 mmol/L; 3) fasting glycemia between 6.1 and 6.9 mmol/L and 4) blood pressure concentrations ≥ 130 / 85 mm Hg.
- Age: between 25 to 50 years
- Stable body weight (+/- 2.5 kg) for at least 3 months before the beginning of the study
- In women, a regular menstrual cycle for the last 3 months
Exclusion Criteria:
- Subjects with endocrine disorders, cardiovascular events, type 1 or 2 diabetes and those using medication that could affect dependent variables measured (namely lipid-lowering, hypoglycemic, insulin sensitizers and anti hypertensive medication)
- Smokers
- Subjects with history of alcoholism
- Subjects with food allergies or food aversion that could impede compliance to the Mediterranean diet
- Pregnant women and those using systemic hormonal contraceptives
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: Ikke-randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: Men and Mediterranean diet
Men who are assigned to a 4 weeks experimental diet formulated to be concordant with characteristics of the traditional Mediterranean diet.
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Men are assigned to a 4 weeks isocaloric controlled nutritional intervention based on the Mediterranean diet (MedDiet) in which all foods and drinks are provided.
The respective percentages of kcal derived from lipids, carbohydrates, protein and alcohol are respectively of 32%, 48%, 15% and 5%.
Habitual energy intake of each participant is established by averaging energy requirements estimated by a validated food-frequency questionnaire (FFQ) and energy needs as determined by the Harris-Benedict formula.
Body weight is measured on weekdays and total energy provided is revised if necessary for minimizing body weight fluctuations.
This intervention period is preceded by a 4 weeks uncontrolled run-in period based on the Canada's Food Guide.
Women are assigned to the same intervention than men in order to compare men and women metabolic response to the MedDiet.
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Eksperimentell: Women and Mediterranean diet
Women who are assigned to a 4 weeks experimental diet formulated to be concordant with characteristics of the traditional Mediterranean diet.
|
Men are assigned to a 4 weeks isocaloric controlled nutritional intervention based on the Mediterranean diet (MedDiet) in which all foods and drinks are provided.
The respective percentages of kcal derived from lipids, carbohydrates, protein and alcohol are respectively of 32%, 48%, 15% and 5%.
Habitual energy intake of each participant is established by averaging energy requirements estimated by a validated food-frequency questionnaire (FFQ) and energy needs as determined by the Harris-Benedict formula.
Body weight is measured on weekdays and total energy provided is revised if necessary for minimizing body weight fluctuations.
This intervention period is preceded by a 4 weeks uncontrolled run-in period based on the Canada's Food Guide.
Women are assigned to the same intervention than men in order to compare men and women metabolic response to the MedDiet.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Cardiometabolic outcomes
Tidsramme: At baseline (at the beginning of the intervention) and at the end of the intervention period (4 weeks).
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Total cholesterol, LDL-cholesterol, HDL-cholesterol, triglycerides, apolipoprotein (apo) B, apo A-1 and apo A-2 plasma concentrations, systolic and diastolic blood pressure, glucose and insulin concentrations during a 180-min oral glucose tolerance test, insulin sensitivity, CRP and Interleukine-6 levels, oxidized-LDL, E-selectin, ICAM-1 and VCAM-1.
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At baseline (at the beginning of the intervention) and at the end of the intervention period (4 weeks).
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Nutritional variables
Tidsramme: At baseline (at the beginning of the intervention), at the end of the intervention period (4 weeks) and at 6-months post-intervention (28 weeks).
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Dietary intakes
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At baseline (at the beginning of the intervention), at the end of the intervention period (4 weeks) and at 6-months post-intervention (28 weeks).
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Eating behaviors
Tidsramme: At baseline (at the beginning of the intervention) and at the end of the intervention period (4 weeks)
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Restraint, disinhibition, and susceptibility to hunger
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At baseline (at the beginning of the intervention) and at the end of the intervention period (4 weeks)
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Appetite ratings
Tidsramme: At baseline (at the beginning of the intervention) and at the end of the intervention period (4 weeks)
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Desire to eat, hunger, fullness, and prospective food consumption
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At baseline (at the beginning of the intervention) and at the end of the intervention period (4 weeks)
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physical activity habits
Tidsramme: At baseline (at the beginning of the intervention) and at the end of the intervention period (4 weeks)
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Weekly questionnaire about physical activities, a validated 3-day physical activity record (two weekdays and one weekend day)
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At baseline (at the beginning of the intervention) and at the end of the intervention period (4 weeks)
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Anthropometric measurements
Tidsramme: At baseline (at the beginning of the intervention), at the end of the intervention period (4 weeks) and at 6-months post-intervention (28 weeks)
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Height, weight, body mass index, waist and hip circumferences,
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At baseline (at the beginning of the intervention), at the end of the intervention period (4 weeks) and at 6-months post-intervention (28 weeks)
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Simone Lemieux, Ph.D., Dt.P., Department of food sciences and nutrition / Institute of Nutraceutical and Functional Foods (INAF), Laval University
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
- Bedard A, Lamarche B, Corneau L, Dodin S, Lemieux S. Sex differences in the impact of the Mediterranean diet on systemic inflammation. Nutr J. 2015 May 12;14:46. doi: 10.1186/s12937-015-0035-y.
- Bedard A, Corneau L, Lamarche B, Dodin S, Lemieux S. Sex-related differences in the effects of the mediterranean diet on glucose and insulin homeostasis. J Nutr Metab. 2014;2014:424130. doi: 10.1155/2014/424130. Epub 2014 Oct 9.
- Bedard A, Tchernof A, Lamarche B, Corneau L, Dodin S, Lemieux S. Effects of the traditional Mediterranean diet on adiponectin and leptin concentrations in men and premenopausal women: do sex differences exist? Eur J Clin Nutr. 2014 May;68(5):561-6. doi: 10.1038/ejcn.2014.27. Epub 2014 Mar 5.
- Bedard A, Dodin S, Corneau L, Lemieux S. Impact of the traditional Mediterranean diet on the Framingham risk score and the metabolic syndrome according to sex. Metab Syndr Relat Disord. 2014 Mar;12(2):95-101. doi: 10.1089/met.2012.0076. Epub 2014 Jan 17.
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
1. oktober 2007
Primær fullføring (Faktiske)
1. april 2010
Studiet fullført (Faktiske)
1. oktober 2010
Datoer for studieregistrering
Først innsendt
9. februar 2011
Først innsendt som oppfylte QC-kriteriene
9. februar 2011
Først lagt ut (Anslag)
10. februar 2011
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
7. oktober 2011
Siste oppdatering sendt inn som oppfylte QC-kriteriene
5. oktober 2011
Sist bekreftet
1. oktober 2011
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- ALIMED-2007-180 A3 R-2
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