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Impacts of Aronia on Inflammation and the Gut Microbiome

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ClinicalTrials.gov Identifier: NCT04128839
Recruitment Status : Completed
First Posted : October 16, 2019
Last Update Posted : October 18, 2019
Sponsor:
Information provided by (Responsible Party):
Montana State University

Brief Summary:
The overall goal of this project is to determine the inflammation lowering impact of anthocyanin-rich Aronia berries. Inflammation is an underlying mechanism driving the development of several diseases. While an elevation in immune signals in the systemic circulation is commonly attributed to adipose tissue, inflammation is not present in all obese individuals. Adipose tissue must become inflamed, and the inflammation trigger may come from other sources. Microorganisms (microbiome), host tissues, and immune cells residing in the gastrointestinal tract (GIT) are a key source of pro-inflammatory signals that may cause the host organism to become inflamed. Anthocyanins are bioactive compounds with established anti-inflammatory and microbiome altering properties. We hypothesize that the GIT microbiome is a key determinant of host inflammation than can be manipulated by anthocyanins-rich berries to lower inflammation. We assembled a cohort of Low-INF and High-INF individuals and characterize their GIT microbiome and performed anthropometric measurements, basal measures of metabolism and metabolic health, and triglyceridemic, metabolomic, and inflammation responses to a high-fat meal challenge. Following this clinical trial, germ-free mice will be humanized with fecal microbial transplants from humans with distinct inflammation phenotypes to determine the impact of Aronia supplementation on the gut microbiome, metabolism, and inflammation.

Condition or disease
Metabolic Syndrome Inflammation Hypertriglyceridemia Obesity

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Study Type : Observational
Actual Enrollment : 40 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Determining the Gut Microbiota-dependent Impacts of Anthocyanin-rich Aronia Berries on Obese Individuals of Distinct Inflammatory Phenotypes
Actual Study Start Date : February 11, 2016
Actual Primary Completion Date : July 2, 2018
Actual Study Completion Date : July 2, 2018



Primary Outcome Measures :
  1. Inflammation state [ Time Frame: 1 day ]
    Serum levels of a six cytokine panel: interleukin (IL)-1B, IL-6, IL-17, IL-23, tumor necrosis factor-alpha (TNF-a), granulocyte macrophage-colony stimulating factor (GM-CSF)

  2. C-reactive protein [ Time Frame: 1 day ]
    C-reactive protein (mg/l)

  3. Gut microbiome [ Time Frame: 1 day ]
    Taxonomic composition of the gut microbiome measured from 16s rRNA sequencing of stool samples

  4. Gut Metabolome [ Time Frame: 1 day ]
    Stool sample metabolome

  5. Postprandial TG Response to a High-fat Meal Challenge [ Time Frame: 1 day ]
    TG concentrations before, 1, 2, 3, and 4 hours following consumption of a meal containing 50 g of fat (toast with butter)

  6. Postprandial Inflammation Response to a High-fat Meal Challenge [ Time Frame: 1 day ]
    Cytokine panel (IL-1B, IL-6, IL-17, IL-23, TNF-a, and GM-CSF) before, 1, 2, 3, and 4 hours following consumption of a meal containing 50 g of fat (toast with butter)

  7. Postprandial Metabolomic Response to a High-fat Meal Challenge [ Time Frame: 1 day ]
    Serum metabolome before, 1, 2, 3, and 4 hours following consumption of a meal containing 50 g of fat (toast with butter)

  8. Glycemic control [ Time Frame: 1 day ]
    Hemoglobin A1c (% glycosylation)

  9. Fasting glucose [ Time Frame: 1 day ]
    Fasting serum glucose (mM)

  10. Fasting insulin [ Time Frame: 1 day ]
    Fasting serum insulin (pmol/l)

  11. Lipid panel [ Time Frame: 1 day ]
    Fasting serum TG, LDL, HDL, and total cholesterol

  12. Fasting metabolites [ Time Frame: 1 day ]
    Serum metabolome measured after an overnight fast

  13. Cardiorespiratory Fitness [ Time Frame: 1 day ]
    Maximal aerobic capacity (ml of O2 per kg of body mass per min)

  14. Self-reported physical activity [ Time Frame: 1 day ]
    Self report of the number of days each week in which aerobic, strength, and stretching type exercises are performed

  15. Blood pressure [ Time Frame: 1 day ]
    Resting systolic and diastolic blood pressure (mmHg)

  16. Body composition [ Time Frame: 1 day ]
    Body composition (% fat, %lean)

  17. Height [ Time Frame: 1 day ]
    Height (m)

  18. Weight [ Time Frame: 1 day ]
    Weight (kg)

  19. Waist circumference [ Time Frame: 1 day ]
    Waist circumference (cm)

  20. Visceral adipose tissue [ Time Frame: 1 day ]
    Volume of visceral adipose tissue (l)


Biospecimen Retention:   Samples With DNA
Serum and fecal specimens (gut microbiome DNA)


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Individuals residing in the Bozeman, MT area
Criteria

Inclusion Criteria:

  • BMI 28-35 kg/m^2

Exclusion Criteria:

  • Antibiotics up to 90 days prior to enrollment
  • Anti-inflammatory medications
  • Allergy or intolerance to wheat or dairy
  • Hormone-based birth control (with exception of intrauterine device)
  • Pregnant
  • Heart disease
  • Other health conditions or concerns that may interfere with study participation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04128839


Sponsors and Collaborators
Montana State University
Investigators
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Principal Investigator: Mary P Miles, PhD Montana State University

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Responsible Party: Montana State University
ClinicalTrials.gov Identifier: NCT04128839    
Other Study ID Numbers: USDA-NIFA 2017-67018-26367
First Posted: October 16, 2019    Key Record Dates
Last Update Posted: October 18, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Montana State University:
gut microbiome
metabolome
postprandial hypertriglyceridemia
low-grade inflammation
visceral adipose tissue
Additional relevant MeSH terms:
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Metabolic Syndrome
Hypertriglyceridemia
Inflammation
Pathologic Processes
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders