Impact of Aronia Berry Consumption on Inflammation, Metabolites, and the Gut Microbiome

NCT05255718 | Completed

• 2 other identifiers: NIFA 2017-67018-26367MC010819
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

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:

1. 1.to determine the impact of Aronia supplementation on inflammation, metabolic health, and gut microbiome composition
2. 2.to determine the static and dynamic metabolomic signature of Aronia based on an Aronia supplementation period and responses to a high-fat meal challenge

Conditions

Inflammation; Metabolic Disorder; Hypertriglyceridemia

Keywords

gut microbiome; metabolome; postprandial hypertriglyceridemia

Outcome Measures

Primary Outcomes (9)

• 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

  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

  4 weeks

• 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

  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

  4 weeks

• Postprandial Serum Metabolomic Response to a High-fat Meal

  Serum metabolome analysis before and 1, 2, 4, and 6 hours after consuming meal containing 50 g fat

  4 weeks

• Postprandial Serum Metabolite (untargeted) Response to High-fat Meal

  Changes in concentrations of metabolites measured with untargeted liquid chromatography mass spectrometry (LCMS) metabolomic analysis after consuming a meal containing 50 g of fat

  4 weeks

• Fasting serum metabolites (untargeted)

  Serum metabolome measured after an overnight fast

  4 weeks

• Gut microbiome composition

  Relative abundance (operational taxonomic units/10,000 reads) of microbial taxa measured from fecal samples

  4 weeks

• Fasting Serum Triglycerides

  Concentration of triglycerides in the serum after an overnight fast

  4 weeks

• Peak Serum Triglyceride Response to High-fat Meal

  Greatest change in triglyceride concentration after consuming a meal containing 50 g of fat

  4 weeks

• Postprandial Serum Triglyceride Response to High-Fat Meal

  Area under the curve for triglyceride concentration after consuming a meal containing 50 g of fat

  4 weeks

Secondary Outcomes (7)

• Blood pressure

  4 weeks

• Weight

  4 weeks

• Height

  4 weeks

• Body composition

  4 weeks

• Waist circumference

  4 weeks

Study Arms (2)

Control

PLACEBO COMPARATOR

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.

Other: Placebo

Aronia

EXPERIMENTAL

100 mL of Aronia juice. Dose of 100 mL is consumed once daily for duration of 28-30 day supplementation period.

Dietary Supplement: Aronia juice

Interventions

Aronia juice DIETARY_SUPPLEMENT

Once daily dose of 100 mL of aronia juice

Aronia

Placebo OTHER

Once daily dose of 100 mL of placebo juice containing no polyphenols and matched to experimental Aronia juice in color, taste, and macronutrient content

Control

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \- 18-60 years

You may not qualify if:

• 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

Sponsors & Collaborators

• Montana State University: lead

Study Sites (1)

Nutrition Research Laboratory

Bozeman, Montana, 59717, United States

Location

MeSH Terms

Conditions

Inflammation; Metabolic Diseases; Hypertriglyceridemia

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders

Study Officials

• Mary P Miles

  Montana State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Double-blind, parallel, control trial with participant randomization to control versus intervention groups.

Study Record Dates

• First Submitted: February 1, 2022
• First Posted: February 24, 2022
• Study Start: April 27, 2019
• Primary Completion: August 18, 2019
• Study Completion: August 18, 2019
• Last Updated: March 13, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)