Impacts of Aronia on Inflammation and the Gut Microbiome

NCT04128839 | Completed

• 1 other identifier: USDA-NIFA 2017-67018-26367
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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 individuals, characterized 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.

Conditions

Metabolic Syndrome; Inflammation; Hypertriglyceridemia; Obesity

Keywords

gut microbiome; metabolome; postprandial hypertriglyceridemia; low-grade inflammation; visceral adipose tissue

Outcome Measures

Primary Outcomes (18)

• Inflammation state

  Serum levels of a eight cytokine panel: interleukin (IL)-1B, IL-6, IL-10, IL-17, IL-23, tumor necrosis factor-alpha (TNF-a), granulocyte macrophage-colony stimulating factor (GM-CSF), interferon gamma (IFNy)

  1 day

• Gut microbiome

  Taxonomic composition of the gut microbiome measured from 16s rRNA sequencing of stool samples

  1 day

• Gut Metabolome

  Stool sample metabolome

  1 day

• Postprandial TG Response to a High-fat Meal Challenge

  TG concentrations before, 1, 2, 4, and 6 hours following consumption of a meal containing 50 g of fat (toast with butter)

  1 day

• Postprandial Inflammation Response to a High-fat Meal Challenge

  Cytokine panel (IL-1B, IL-6, IL-10, IL-17, IL-23, TNF-a, GM-CSF, and IFNy) before, 1, 2, 4, and 6 hours following consumption of a meal containing 50 g of fat (toast with butter)

  1 day

• Postprandial Metabolomic Response to a High-fat Meal Challenge

  Serum metabolome before, 1, 2, 4, and 6 hours following consumption of a meal containing 50 g of fat (toast with butter)

  1 day

• Glycemic control

  Hemoglobin A1c (% glycosylation)

  1 day

• Fasting glucose

  Fasting serum glucose (mM)

  1 day

• Fasting insulin

  Fasting serum insulin (pmol/l)

  1 day

• Lipid panel

  Fasting serum TG, LDL, HDL, and total cholesterol

  1 day

• Fasting metabolites

  Serum metabolome measured after an overnight fast

  1 day

• Self-reported physical activity

  Self report of the number of days each week in which aerobic, strength, and stretching type exercises are performed

  1 day

• Blood pressure

  Resting systolic and diastolic blood pressure (mmHg)

  1 day

• Body composition

  Body composition (% fat, %lean)

  1 day

• Height

  Height (m)

  1 day

• Weight

  Weight (kg)

  1 day

• Waist circumference

  Waist circumference (cm)

  1 day

• Visceral adipose tissue

  Volume of visceral adipose tissue (l)

  1 day

Study Arms (2)

Aronia juice (ARO)

EXPERIMENTAL

A juice blend of three different cultivars was used: Viking, MacKenzie and Autumn Magic. Raw juice was heat pasteurized before provided to participants. Participants consumed 100 mL of juice per day for duration of intervention period (28-30 days)

Dietary Supplement: Aronia berry juice

Placebo juice (PLA)

SHAM COMPARATOR

The placebo juice was flavor, color, and carbohydrate-matched to experimental Aronia juice. PLA consisted of 28.8 g black cherry Koolaid mix (no sugar added), 128.5 g sorbitol, 74.5 g glucose, 77.9 g fructose, 4 oz lemon juice, 16 drops of blue food coloring, and enough water to create 1 L of solution. Participants consumed 100 mL of juice per day for duration of intervention period (28-30 days)

Other: Sham comparator

Interventions

Aronia berry juice DIETARY_SUPPLEMENT

A juice blend of three different cultivars was used: Viking, MacKenzie and Autumn Magic. Raw juice was heat pasteurized before provided to participants. Participants consumed 100 mL of juice per day.

Aronia juice (ARO)

Sham comparator OTHER

The placebo was flavor, color, and carbohydrate-matched to aronia juice. The placebo consisted of 28.8 g black cherry Koolaid mix (no sugar added), 128.5 g sorbitol, 74.5 g glucose, 77.9 g fructose, 4 oz lemon juice, 16 drops of blue food coloring, and enough water to create 1 L of solution. Participants consumed 100 mL of juice per day.

Placebo juice (PLA)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• BMI 28-35 kg/m\^2

You may not qualify if:

• 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

Sponsors & Collaborators

• Montana State University: lead

Study Sites (1)

Montana State University

Bozeman, Montana, 59717, United States

Location

Related Publications (1)

• Wilson SM, Maes AP, Yeoman CJ, Walk ST, Miles MP. Determinants of the postprandial triglyceride response to a high-fat meal in healthy overweight and obese adults. Lipids Health Dis. 2021 Sep 20;20(1):107. doi: 10.1186/s12944-021-01543-4.

  PMID: 34544430 DERIVED

MeSH Terms

Conditions

Metabolic Syndrome; Inflammation; Hypertriglyceridemia; Obesity

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms

Study Officials

• Mary P Miles, PhD

  Montana State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Placebo (PLA) was flavor, color, and carbohydrate matched to intervention treatment of Aronia juice. PLA consisted of 28.8 g black cherry Koolaid mix (no sugar added), 128.5 g sorbitol, 74.5 g glucose, 77.9 g fructose, 4 oz lemon juice, 16 drops of blue food coloring, and enough water to create 1 L of solution. Participants consumed 100 mL/ day.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2019
• First Posted: October 16, 2019
• Study Start: April 27, 2019
• Primary Completion: September 30, 2019
• Study Completion: December 27, 2021
• Last Updated: January 16, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)