Effects of the Mediterranean Diet on Cardiovascular Risk Profile in Men and Women (ALIMED)
5 października 2011 zaktualizowane przez: 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.
Przegląd badań
Status
Zakończony
Warunki
Szczegółowy opis
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.
Typ studiów
Interwencyjne
Zapisy (Rzeczywisty)
70
Faza
- Nie dotyczy
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Lokalizacje studiów
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Quebec, Kanada, G1V0A6
- Institute of Nutraceuticals and Functional Foods (INAF), Laval University
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Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
25 lat do 50 lat (Dorosły)
Akceptuje zdrowych ochotników
Nie
Płeć kwalifikująca się do nauki
Wszystko
Opis
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
Plan studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Zapobieganie
- Przydział: Nielosowe
- Model interwencyjny: Przydział równoległy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
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Eksperymentalny: 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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Eksperymentalny: 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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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
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Cardiometabolic outcomes
Ramy czasowe: 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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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
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Nutritional variables
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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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Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Sponsor
Śledczy
- Główny śledczy: Simone Lemieux, Ph.D., Dt.P., Department of food sciences and nutrition / Institute of Nutraceutical and Functional Foods (INAF), Laval University
Publikacje i pomocne linki
Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.
Publikacje ogólne
- 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.
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów
1 października 2007
Zakończenie podstawowe (Rzeczywisty)
1 kwietnia 2010
Ukończenie studiów (Rzeczywisty)
1 października 2010
Daty rejestracji na studia
Pierwszy przesłany
9 lutego 2011
Pierwszy przesłany, który spełnia kryteria kontroli jakości
9 lutego 2011
Pierwszy wysłany (Oszacować)
10 lutego 2011
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Oszacować)
7 października 2011
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
5 października 2011
Ostatnia weryfikacja
1 października 2011
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- ALIMED-2007-180 A3 R-2
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .