- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT01027052
Spices Inhibit the Formation and Absorption of Malondialdehyde From Hamburger Meat
Absorption, Metabolism and Antioxidant Effects of Common Herbs
Polyphenols belong to the largest group of secondary metabolites produced by plants, mainly, in response to biotic or abiotic stresses such as infections, wounding, UV irradiation, exposure to ozone, pollutants, and other hostile environmental conditions. It is thought that the molecular basis for the protective action of polyphenols in plants is their antioxidant and free radical scavenging properties. These numerous phenolic compounds are major biologically active components of spices, aromas, essential oils, and traditional medicines. In order to investigate the impact of spice polyphenols on postprandial cytotoxic lipid peroxidation products (MDA) levels in humans, the investigators propose to achieve the following specific aims using a randomized crossover study design:
- To determine the effect of a ground beef patty meal with and without spices on postprandial levels of plasma malondialdehyde (MDA).
- To determine the effect of a ground beef patty meal with and without a spice blend on MDA accumulation in urine.
This study will determine whether spice polyphenols exert a beneficial effect by inhibition of the absorption of MDA. These findings may help to explain the potentially harmful effects of oxidizable fats found in foods and the important benefit of dietary polyphenols in ameliorating this potentially harmful effect.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Male or female, 20-45 years of age
- Non-smokers, or smoke < 1 cigarette per day
- Not exercising heavily (< 4 x 30 minutes aerobic exercise per week)
- Willing to maintain normal activity and eating patterns for the duration of the study
- Willing to avoid meat, fish or poultry for three days on two occasions prior to the test procedure
- Consuming less than two alcoholic drinks per day
- Not taking dietary supplements
- No known allergy to beef, cloves, cinnamon, oregano, turmeric, cumin, rosemary, sage, red pepper, ginger, black pepper, paprika or garlic
Exclusion Criteria:
- Metabolic disorders
- Taking dietary supplements
- Smoking >1 cigarette/day
- Exercising heavily (>4x30 min of aerobic exercise/wk)
- Drinking more than 2 glasses of wine, 2 cocktails or two beers /day.
- Allergic to beef, cloves, cinnamon, oregano, turmeric, cumin, rosemary, sage, red pepper, ginger, black pepper, paprika or garlic
- Known HIV positive
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Autre
- Répartition: Randomisé
- Modèle interventionnel: Affectation croisée
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Comparateur actif: Hamburger meat patty with Spice Blend
Hamburger meat patty containing spice blend will be consumed on 3 separate occasions
|
hamburger meat cooked with spice mixture
|
Comparateur placebo: Hamburger meat patty with salt
Hamburger meat patty containing salt will be consumed on 3 separate occasions
|
hamburger meat cooked with salt
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Change in plasma and urinary MDA after consumption of hamburg with or without spice mixture added
Délai: 2 days
|
Change in plasma and urinary MDA after consumption of 250 g hamburg meat with 11.3 g spice mixture added or without spice
|
2 days
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Zhaoping Li, MD, PhD, David Geffen School of Medicine, UCLA Center for Human Nutrtiion
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
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 (Estimation)
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
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .