Effects of the Mediterranean Diet on Cardiovascular Risk Profile in Men and Women (ALIMED)
5. Oktober 2011 aktualisiert von: 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.
Studienübersicht
Status
Abgeschlossen
Bedingungen
Detaillierte Beschreibung
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.
Studientyp
Interventionell
Einschreibung (Tatsächlich)
70
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
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Quebec, Kanada, G1V0A6
- Institute of Nutraceuticals and Functional Foods (INAF), Laval University
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Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
25 Jahre bis 50 Jahre (Erwachsene)
Akzeptiert gesunde Freiwillige
Nein
Studienberechtigte Geschlechter
Alle
Beschreibung
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
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Verhütung
- Zuteilung: Nicht randomisiert
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
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Experimental: 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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Experimental: 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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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Cardiometabolic outcomes
Zeitfenster: 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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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
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Nutritional variables
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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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Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Ermittler
- Hauptermittler: Simone Lemieux, Ph.D., Dt.P., Department of food sciences and nutrition / Institute of Nutraceutical and Functional Foods (INAF), Laval University
Publikationen und hilfreiche Links
Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.
Allgemeine Veröffentlichungen
- 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.
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn
1. Oktober 2007
Primärer Abschluss (Tatsächlich)
1. April 2010
Studienabschluss (Tatsächlich)
1. Oktober 2010
Studienanmeldedaten
Zuerst eingereicht
9. Februar 2011
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
9. Februar 2011
Zuerst gepostet (Schätzen)
10. Februar 2011
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
7. Oktober 2011
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
5. Oktober 2011
Zuletzt verifiziert
1. Oktober 2011
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- ALIMED-2007-180 A3 R-2
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