- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT04275843
The Effects of Western Diet Patterns on Plasma Inflammatory and Cardio Metabolic Health Signatures in Middle-aged Adults
The Western diet pattern or standard American diet is a modern dietary pattern that is characterized by high intakes of meat, pre-packaged foods, fried foods, high-fat dairy products, eggs, refined grains etc. When considering the role of saturated fat, it may be prudent to advise limiting all foods that contain saturated fats, including unprocessed/minimally processed meat, eggs, whole dairy in addition to processed, pre-packaged foods; however, this reductionist approach fails to take into account the food matrix and overall diet in which these nutrients are consumed.
Epidemiological evidence suggests that increased modern, pre-packaged food consumption is a major risk factor for metabolic disease by promoting inflammation. Based on these data, the investigators hypothesize that the pro-atherogenic effect of the Western diet is caused by the pro-inflammatory effects of consuming large amounts of modern ultra-processed foods, and that consumption of a similar amount of fat from minimally processed beef, poultry, dairy, eggs, as part of an unprocessed diet will positively impact inflammatory markers and lipoprotein profiles of study participants when compared to a diet rich in modern ultra-processed foods.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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North Carolina
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Durham, North Carolina, États-Unis, 27701
- Duke University School of Medicine
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-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Age ≥35 and ≤60 years;
- BMI ≥25 and ≤35 kg/m2;
- Weight stable in last 3 months (Loss or gain <4%);
- Consistent physical activity levels;
- Hemoglobin A1C (HbA1C) ≤6.4%;
- Fasting insulin; <15 µU/mL;
- Fasting plasma glucose concentration <126 mg/dl;
- Willingness to eat the food provided in this study;
- Subjects must be able to speak and understand English to participate in this study
- Own a smartphone or other mobile device capable of downloading the Garmin Connect app.
Exclusion Criteria:
- Diagnoses of active malignancy, congestive heart failure, diabetes mellitus, chronic obstructive pulmonary disease, thyroid disease or other metabolic disorders that influence metabolism;
- Evidence of impaired kidney function (Estimated glomerular filtration rate [eGFR] <44 mL/min;
- Regular use of medication that interferes with the measurement of study outcomes as determined by the study team (e.g., NSAIDs, corticosteroids);
- Consuming >14 drinks per week of >4 drinks per night twice/week for male; >7 drinks per week or >3 drinks per night twice/week for female;
- Use of cigarettes (or other tobacco products) or use of any other (recreational) drug in last 3 months;
- Engaged in high-level competitive exercise (e.g., marathons, triathlons, cycling, weight-lifting competitions etc.)
- Self-reported sleep duration <5 hours per night;
- Any inflammatory diseases (e.g. asthma, autoimmune diseases, coeliac disease, glomerulonephritis, hepatitis, inflammatory bowel disease, arthritis);
- Use of antibiotics in last 30 days;
- Pregnant or lactating women;
- Eating disorders (e.g., anorexia nervosa, bulimia nervosa, binge eating disorders etc.)
- Psychological disorders (e.g., clinical depression, bipolar disorders etc.);
- Strict dietary patterns (e.g., vegan, carnivore, kosher, low-carb etc.);
- History of stomach or bowel resection (other than appendectomy), gastric bypass or other bariatric weight loss procedure effecting absorption;
- Persons who are not able to grant voluntary informed consent;
- Persons who are unable or unwilling to follow the study protocol or who, for any reason, the research team considers not an appropriate candidate for this study, including non-compliance with screening appointments or study visits.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Science basique
- Répartition: Randomisé
- Modèle interventionnel: Affectation croisée
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Comparateur actif: Traditional Diet
Unprocessed/minimally processed whole foods.
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Consuming an traditional whole foods based diet for 4 weeks.
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|
Comparateur actif: Modern Diet
Multi-ingredient, ultra-processed formulations of the traditional diet.
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Consuming an processed formulation of the traditional diet for 4 weeks.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in plasma interleukin-6 levels
Délai: Baseline, up to 4 weeks.
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Plasma interleukin-6 levels will be measured before and after each diet
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Baseline, up to 4 weeks.
|
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Change in plasma c-reactive protein levels
Délai: Baseline, up to 4 weeks.
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Plasma c-reactive protein levels levels will be measured before and after each diet
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Baseline, up to 4 weeks.
|
|
Change in plasma acylcarnitine profiles
Délai: Baseline, up to 4 weeks.
|
Plasma acylcarnitines profiles levels will be measured before and after each diet
|
Baseline, up to 4 weeks.
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in gut microbiota communities
Délai: Baseline, up to 4 weeks.
|
Bifidobacterium, Faecalibacterium prausnitzii, Anerostipes, Roseburia
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Baseline, up to 4 weeks.
|
|
Energy expenditure
Délai: up to 4 weeks.
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Measured by the doubly labeled water method during the last week of each diet
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up to 4 weeks.
|
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Change in Neuroinflammation
Délai: Baseline, up to 4 weeks.
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Neurofilament light (NfL), glial fibrillary acidic protein (GFAP), Aß42 and p-tau will be measured before and after each diet
|
Baseline, up to 4 weeks.
|
Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Directeur d'études: Stephan van Vliet, PhD, Duke University
- Chercheur principal: Kim Huffman, MD, PhD, Duke University
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- Pro00103827
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
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