The Influence of Daily Intake of Whole Grain Barley or Oats on Biomarkers of Cardiovascular Disease
13 octobre 2011 mis à jour par: United States Department of Agriculture (USDA)
The objectives of this study are the following: 1) to determine the effect of daily consumption of whole grain barley for six week on risk factors of cardiovascular disease compared to a diet low in whole grains, and 2) to compare the effects of daily consumption of whole grain barley to those of whole grain oats for six weeks to determine if the response to these two grains is different.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Anticipé)
69
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Maryland
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Beltsville, Maryland, États-Unis, 20705
- USDA Beltsville Human Nutrition Research Center
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
25 ans à 70 ans (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
Inclusion Criteria:
- Men and women between the ages of 25-70 years
- Body mass index (BMI) ≥ 19 and ≤ 38
- Willingness and ability to make scheduled appointments at clinical site as required by study protocol
Exclusion Criteria:
- Do not regularly consume breakfast or dislike cereal for breakfast
- Known (self-reported) allergy or adverse reaction to grains (e.g., wheat, gluten, barley)
- Presence of kidney disease, liver disease, gout, untreated or unstable hypothyroidism, untreated or unstable hyperthyroidism, certain cancers, gastrointestinal disease, pancreatic disease, other metabolic diseases, or malabsorption syndromes
- Type 2 diabetes requiring the use of oral antidiabetic agents or insulin
- Fasting triglycerides > 300 mg/dL
- Fasting glucose > 126 mg/dL
- Use of cholesterol lowering medication
- Blood pressure > 180/100 or hypertension treated with calcium channel blockers, direct acting vasodilators, or beta blockers
- History of bariatric or certain other surgeries related to weight control
- History of major surgery within 3 months of enrollment
- Smokers or other tobacco users (during 6 months prior to the start of the study)
- Antibiotic use during the intervention or for 3 months prior to the intervention period
- History of eating disorders or other dietary patterns which are not consistent with the dietary intervention (e.g., vegetarians, very low fat diets, high protein diets)
- Volunteers who have lost 10% of body weight within the last 6 months
- Unable or unwilling to give informed consent or communicate with study staff
- Self-report of alcohol or substance abuse within the past 12 months and/or current acute treatment or rehabilitation program for these problems (long-term participation in Alcoholics Anonymous is not an exclusion)
- Other medical, psychiatric, or behavioral factors that in the judgment of the Principal Investigator may interfere with study participation or the ability to follow the intervention protocol
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Tripler
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Expérimental: Whole Grain Barley Diet
A controlled diet containing at least 4 daily servings of whole grain barley.
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Subjects will be randomly assigned to one of three treatments: 1) a control diet containing 0.7 daily servings of whole grain, 2) a diet containing at least 4 daily servings of whole grain barley or 3) a diet containing at least 4 servings of whole grain oats.
After 6 weeks, risk factors of cardiovascular disease will be assessed after a 12 hr fast.
During the seventh week, risk factors of cardiovascular disease will be assessed in the postprandial state.
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Comparateur actif: Whole Grain Oats Diet
A diet containing at least 4 servings of whole grain oats.
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Subjects will be randomly assigned to one of three treatments: 1) a control diet containing 0.7 daily servings of whole grain, 2) a diet containing at least 4 daily servings of whole grain barley or 3) a diet containing at least 4 servings of whole grain oats.
After 6 weeks, risk factors of cardiovascular disease will be assessed after a 12 hr fast.
During the seventh week, risk factors of cardiovascular disease will be assessed in the postprandial state.
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Autre: Low Whole Grain Diet
A control diet containing 0.7 daily servings of whole grain.
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Subjects will be randomly assigned to one of three treatments: 1) a control diet containing 0.7 daily servings of whole grain, 2) a diet containing at least 4 daily servings of whole grain barley or 3) a diet containing at least 4 servings of whole grain oats.
After 6 weeks, risk factors of cardiovascular disease will be assessed after a 12 hr fast.
During the seventh week, risk factors of cardiovascular disease will be assessed in the postprandial state.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Meal Tolerance Assessment
Délai: 7 hours
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Subjects will provide a baseline blood sample at 15 minutes and 5 minutes prior to consuming a test meal.
Subjects will then consume a high fat breakfast of foods such as eggs, buttered English muffins, and donuts.
Blood samples will be collected 30, 60, 90, 120, 150, 180, 210, 240, 270, 300, 360, and 420 min following ingestion of the test meal.
Measurements will be made for serum triglyceride area under the curve, serum cholesterol, insulin, glucose, and plasma apo B48.
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7 hours
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Biomarkers of cardiovascular risk
Délai: After a 12 hour fast
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Fibrinogen, factor VII, blood pressure, total cholesterol, HDL-cholesterol, LDL-cholesterol, triglycerides, Lp(a), and lipoprotein size.
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After a 12 hour fast
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Biomarkers of oxidative stress
Délai: After 6 weeks of feeding
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Nitrites and nitrates, malondialdehyde, lipid hydroperoxides, ox-LDL, resistance of LDL to Cu2+-induced oxidation, FRAP, glutathione, glutathione-S-transferase, super oxide dismutase, PON-1, betaine, homocysteine, total thiols, urinary isoprostanes.
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After 6 weeks of feeding
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Biomarkers of inflammation
Délai: After 6 weeks of controlled feeding
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C-reactive protein (CRP), IL-6, IL-8, IL-10, IL-18, TNFα, matrix metalloproteinases (MMP-2, MMP-9), e-Selectin, ICAM, VCAM
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After 6 weeks of controlled feeding
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Biomarkers of glucoregulatory control
Délai: After 6 weeks of feeding
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Glycated apolipoprotein B, hemoglobin A1c, fructosamine, insulin, glucose, leptin, adiponectin
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After 6 weeks of feeding
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Genotype testing
Délai: After 6 weeks of controlled feeding
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Blood will be used to test for genetic traits that may influence nutrient metabolism and also traits reflecting the mechanisms that may be influenced by the intervention.
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After 6 weeks of controlled feeding
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Microarray and targeted gene expression testing
Délai: After 6 weeks of controlled feeding
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Blood samples will be used to test how the intervention affects gene expression.
Global gene expression will be performed for a complete survey of the RNA response to the intervention.
Targeted gene expression will be performed to confirm the findings of the global gene expression analysis.
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After 6 weeks of controlled feeding
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Collaborateurs
Les enquêteurs
- Chercheur principal: Janet A Novotny, PhD, USDA Beltsville Human Nutrition Research Center
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 mai 2011
Achèvement primaire (Réel)
1 août 2011
Achèvement de l'étude (Réel)
1 août 2011
Dates d'inscription aux études
Première soumission
8 février 2011
Première soumission répondant aux critères de contrôle qualité
9 février 2011
Première publication (Estimation)
10 février 2011
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
14 octobre 2011
Dernière mise à jour soumise répondant aux critères de contrôle qualité
13 octobre 2011
Dernière vérification
1 octobre 2011
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- HS34
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