The Influence of Daily Intake of Whole Grain Barley or Oats on Biomarkers of Cardiovascular Disease
13 oktober 2011 uppdaterad av: 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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Förväntat)
69
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Maryland
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Beltsville, Maryland, Förenta staterna, 20705
- USDA Beltsville Human Nutrition Research Center
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
25 år till 70 år (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Trippel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: 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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Aktiv komparator: 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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Övrig: 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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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Meal Tolerance Assessment
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Genotype testing
Tidsram: 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
Tidsram: 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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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Samarbetspartners
Utredare
- Huvudutredare: Janet A Novotny, PhD, USDA Beltsville Human Nutrition Research Center
Publikationer och användbara länkar
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Användbara länkar
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 maj 2011
Primärt slutförande (Faktisk)
1 augusti 2011
Avslutad studie (Faktisk)
1 augusti 2011
Studieregistreringsdatum
Först inskickad
8 februari 2011
Först inskickad som uppfyllde QC-kriterierna
9 februari 2011
Första postat (Uppskatta)
10 februari 2011
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
14 oktober 2011
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
13 oktober 2011
Senast verifierad
1 oktober 2011
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- HS34
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
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