Berries, Inflammation, and Gut Microbiome

NCT04100200 | Active Not Recruiting

• 1 other identifier: IRB2018-121
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objectives are to characterize changes in indices of systemic and gut inflammation, assess host- and microbial-derived metabolite pools, and describe and link functional metagenomics and metatranscriptomic alterations in the gut microbiome with metabolite and inflammatory outcomes after acute (24hr) and chronic (4 week) intake of anthocyanins and ellagitannins from strawberry and red raspberries compared to a control diet (negative control), FOS (positive control, non-polyphenol, carbohydrate-based fermentable fiber/pre-biotic), or combination diet (berry composite + FOS) in human participants with low-grade inflammation.

Conditions

Healthy; Overweight or Obesity

Keywords

Strawberry; Raspberry; Metabolic responses; Gut microbiome; Inflammatory markers

Outcome Measures

Primary Outcomes (3)

• Changes in plasma biomarkers and measures of inflammation concentration: Nrf2/ NF-κB -response between 4 treatments

  Plasma biomarkers and measures of inflammation: Nrf2/ NF-κB activation in monocytes will be analyzed.

  Baseline to 4 weeks

• Changes in plasma biomarkers and measures of inflammation concentration-response between 4 treatments

  Inflammatory cytokines (Interleukin-6 (IL-6), High Sensitivity C-Reactive Protein (hs-CRP), Tumor Necrosis Factor-α (TNF-α)) will be measured.

  Baseline to 4 weeks

• Changes in plasma biomarkers and measures of inflammation concentration (GLP-2)-response between 4 treatments

  Analysis of GLP-2 will be done in plasma samples before and after chronic exposure to the study foods.

  Baseline to 4 weeks

Secondary Outcomes (2)

• Changes in gut inflammatory markers between 4 treatments.

  Baseline to 4 weeks

• Changes in Bile acids between 4 treatments.

  Baseline to 4 weeks

Other Outcomes (1)

• Characterize metabolite profiles (phenolic acids and urolithin derivatives) in urine and plasma.

  Baseline to 4 weeks

Study Arms (4)

Mixed Berries

ACTIVE COMPARATOR

Strawberry and red raspberry composite served as a frozen drink

Dietary Supplement: Mixed berries

FOS

ACTIVE COMPARATOR

Non-polyphenol, carbohydrate-based fermentable fiber/pre-biotic served as a frozen drink

Dietary Supplement: FOS

Combination

ACTIVE COMPARATOR

Mixed berry composite + FOS served as a frozen drink

Dietary Supplement: Combination

Control

PLACEBO COMPARATOR

Placebo similar in color to mixed berry supplement without any polyphenols served as a frozen drink

Dietary Supplement: Control

Interventions

Combination DIETARY_SUPPLEMENT

Mixed berry composite + FOS

Combination

Mixed berries DIETARY_SUPPLEMENT

Strawberry and red raspberry

Mixed Berries

FOS DIETARY_SUPPLEMENT

Fructo-oligosaccharide

FOS

Control DIETARY_SUPPLEMENT

Placebo similar in color to mixed berry supplement without any polyphenols

Control

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• C-Reactive Protein (hs-CRP) \> 1.0 and ≤ 10 ng/L
• BMI ≥ 25 kg/m2
• Aged 20-60 years
• Able to provide informed consent and comply with study procedures
• Willing to maintain stable body weight and follow his/her habitual diet and physical activity patterns throughout the trial.
• Judged by the Investigator to be in general good health on the basis of medical history and screening laboratory tests.
• People with no documented disease condition that would interfere with the study endpoints (ie., CVD, diabetes, hypertension, major organ diseases) or taking medication or dietary supplements that may interfere with study endpoints

You may not qualify if:

• Current smoker or marijuana user
• No history or presence of atherosclerosis/cardiovascular disease, inflammatory disease, diabetes mellitus, or other systemic diseases, psychological or psychiatric disorders that may interfere with study outcomes.
• Taking any medications and/or supplements that would interfere with outcomes of the study (i.e., lipid-lowering medications, anti-inflammatory drugs, etc)
• Take part in prebiotics, probiotics or drugs active on gastrointestinal motility or a laxative of any class within 1 month
• Unstable use of any medication/supplement, this could include marijuana used as -needed for medical reasons
• Have a history of cancer, except for non-melanoma skin cancer in past 5 years
• Addicted to drugs and/or alcohol (\>4 drinks/day)
• Have been exposed to any non-registered drug product within last 30 days.
• Working overnight (e.g. 3rd shift of overnight workers)
• Excessive exercisers or trained athletes
• Have allergies/intolerances to any of the study products.
• Extreme dietary habits (ie. vegetarian/vegan)
• Excessive coffee/tea drinker (\>4 cups/day)
• Actively losing weight/ trying to lose weight (unstable body weight fluctuations of \> 5 kg in 3 months)
• Donated blood within last 3 months

Sponsors & Collaborators

• Clinical Nutrition Research Center, Illinois Institute of Technology: lead
• USDA Beltsville Human Nutrition Research Center: collaborator

Study Sites (1)

Clinical Nutrition Research Center

Chicago, Illinois, 60616, United States

Location

MeSH Terms

Conditions

Overweight; Obesity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Amandeep Sandhu, Ph.D

  Institue for Food Safety and Health/Illinois Insititute of Technology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2019
• First Posted: September 24, 2019
• Study Start: October 7, 2019
• Primary Completion: March 31, 2023
• Study Completion (Estimated): October 1, 2026
• Last Updated: March 25, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)