Impact of Aronia Berry Consumption on Inflammation, Metabolites, and the Gut Microbiome
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ClinicalTrials.gov Identifier: NCT05255718 |
Recruitment Status :
Completed
First Posted : February 24, 2022
Last Update Posted : March 13, 2024
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The goal of this project is to elucidate interactions between the gut microbiome, anti-inflammatory/anti-oxidant food metabolomic signatures, and human inflammation phenotypes. Inflammation plays both direct and indirect roles in the development of type 2 diabetes (T2D), atherogenic cardiovascular diseases, and other causes of morbidity and mortality. Aronia melanocarpa (Aronia berries) are rich in bioactive polyphenolic compounds, which have been shown to lower inflammation and favorably impact metabolism. However, there is tremendous inter-individual variability in the bioavailability of polyphenolics and production of bioactive phenolic metabolites in the colon that depends, at least in part, on digestive metabolism by the gut microbiota. Little is known about the complex interactions among the gut microbiome, anti-inflammatory food metabolomic signatures, and human inflammation phenotypes. This study will utilize a systems-level approach to disentangle these complex interactions. The specific study objectives are as follows:
- to determine the impact of Aronia supplementation on inflammation, metabolic health, and gut microbiome composition
- to determine the static and dynamic metabolomic signature of Aronia based on an Aronia supplementation period and responses to a high-fat meal challenge
Condition or disease | Intervention/treatment | Phase |
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Inflammation Metabolic Disorder Hypertriglyceridemia | Dietary Supplement: Aronia juice Other: Placebo | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 13 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | Double-blind, parallel, control trial with participant randomization to control versus intervention groups. |
Masking: | Double (Participant, Investigator) |
Masking Description: | Use of placebo juice matched in flavor, color, and macronutrient content to interventional Aronia juice. Assignment of participants to placebo versus intervention treatments performed by independent researcher and masked until completion of study. |
Primary Purpose: | Prevention |
Official Title: | Antioxidant-rich Aronia Supplementation Impacts Human Metabolism and Immune Response as Well as Gut Microbiome Metabolism |
Actual Study Start Date : | April 27, 2019 |
Actual Primary Completion Date : | August 18, 2019 |
Actual Study Completion Date : | August 18, 2019 |
Arm | Intervention/treatment |
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Placebo Comparator: Control
The placebo supplement will have no polyphenol content and will consist of 100 mL of the following mixture: black cherry Koolaid, blue and red food coloring, sucrose and sorbitol. This placebo will match the sugar content of the chokeberry juice. Dose of 100 mL is consumed once daily for duration of 28-30 day supplementation period.
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Other: Placebo
Once daily dose of 100 mL of placebo juice containing no polyphenols and matched to experimental Aronia juice in color, taste, and macronutrient content |
Experimental: Aronia
100 mL of Aronia juice. Dose of 100 mL is consumed once daily for duration of 28-30 day supplementation period.
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Dietary Supplement: Aronia juice
Once daily dose of 100 mL of aronia juice |
- Postprandial Serum Inflammatory Cytokine (tumor necrosis factor-alpha, interleukin-(IL)1beta, IL-6, IL-10, IL-17, IL-23, interferon-gamma, and granulocyte macrophage-colony stimulating factor; all in pg/ml) Response to High-fat Meal [ Time Frame: 4 weeks ]Area under the curve for inflammatory cytokine (tumor necrosis factor-alpha, interleukin-(IL)1beta, IL-6, IL-10, IL-17, IL-23, interferon-gamma, and granulocyte macrophage-colony stimulating factor; all in pg/ml) concentrations after consuming a meal containing 50 g of fat
- Peak Serum Cytokine (tumor necrosis factor-alpha, interleukin-(IL)1beta, IL-6, IL-10, IL-17, IL-23, interferon-gamma, and granulocyte macrophage-colony stimulating factor; all in pg/ml) Response to High-fat Meal [ Time Frame: 4 weeks ]Greatest change in inflammatory cytokine (tumor necrosis factor-alpha, interleukin-(IL)1beta, IL-6, IL-10, IL-17, IL-23, interferon-gamma, and granulocyte macrophage-colony stimulating factor; all in pg/ml) concentration after consuming a meal containing 50 g of fat
- Postprandial Serum Metabolomic Response to a High-fat Meal [ Time Frame: 4 weeks ]Serum metabolome analysis before and 1, 2, 4, and 6 hours after consuming meal containing 50 g fat
- Postprandial Serum Metabolite (untargeted) Response to High-fat Meal [ Time Frame: 4 weeks ]Changes in concentrations of metabolites measured with untargeted liquid chromatography mass spectrometry (LCMS) metabolomic analysis after consuming a meal containing 50 g of fat
- Fasting serum metabolites (untargeted) [ Time Frame: 4 weeks ]Serum metabolome measured after an overnight fast
- Gut microbiome composition [ Time Frame: 4 weeks ]Relative abundance (operational taxonomic units/10,000 reads) of microbial taxa measured from fecal samples
- Fasting Serum Triglycerides [ Time Frame: 4 weeks ]Concentration of triglycerides in the serum after an overnight fast
- Peak Serum Triglyceride Response to High-fat Meal [ Time Frame: 4 weeks ]Greatest change in triglyceride concentration after consuming a meal containing 50 g of fat
- Postprandial Serum Triglyceride Response to High-Fat Meal [ Time Frame: 4 weeks ]Area under the curve for triglyceride concentration after consuming a meal containing 50 g of fat
- Blood pressure [ Time Frame: 4 weeks ]Resting systolic and diastolic blood pressure (mmHg)
- Weight [ Time Frame: 4 weeks ]Weight (kg)
- Height [ Time Frame: 4 weeks ]Height (m)
- Body composition [ Time Frame: 4 weeks ]Body composition (% fat, % lean)
- Waist circumference [ Time Frame: 4 weeks ]Waist circumference (cm_)
- Visceral adipose tissue [ Time Frame: 4 weeks ]Volume of visceral adipose tissue (L)
- Habitual Diet [ Time Frame: 4 weeks ]Habitual dietary intake from past month report through a food frequency questionnaire for food, beverage, and supplement intake
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Ages Eligible for Study: | 18 Years to 60 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- 18-60 years
Exclusion Criteria:
- Individuals who are pregnant or have other health conditions that might make it difficult to participate in the study, including heart disease, diabetes, and hypertension
- Individuals who are unwilling or unable to complete multiple venipuncture collections.
- Individuals who have food allergies or sensitivities to berry fruits
- Individuals unwilling or unable to avoid foods on provided food list for the duration of the supplementation period.
- Individuals who have food allergies or dietary restrictions to any of the foods being used, including wheat, dairy, or Aronia berries (chokeberries)
- Individuals taking blood pressure, lipid-lowering, or anti-inflammatory medications
- Individuals who have taken antibiotics in previous 90 days
- Individuals who have food allergy or intolerance to red food dye
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): NCT05255718
United States, Montana | |
Nutrition Research Laboratory | |
Bozeman, Montana, United States, 59717 |
Principal Investigator: | Mary P Miles | Montana State University |
Responsible Party: | Montana State University |
ClinicalTrials.gov Identifier: | NCT05255718 |
Other Study ID Numbers: |
NIFA 2017-67018-26367 MC010819 ( Other Identifier: Institutional Review Board ) |
First Posted: | February 24, 2022 Key Record Dates |
Last Update Posted: | March 13, 2024 |
Last Verified: | March 2024 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
gut microbiome metabolome postprandial hypertriglyceridemia |
Hypertriglyceridemia Metabolic Diseases Inflammation Pathologic Processes |
Hyperlipidemias Dyslipidemias Lipid Metabolism Disorders |