Overweight or ObesityNCT04100200
Berries, Inflammation, and Gut Microbiome
A study testing Mixed berries, FOS and Combination in people with Overweight or Obesity and Healthy, run by Clinical Nutrition Research Center, Illinois Institute of Technology at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight or Obesity, Healthy
- What is being tested?
- Mixed berries, FOS and Combination
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 105 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Oct 2019to 1 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 18Show fewer
- 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
- Participated in a clinical trial within 1 month
- Female who is pregnant, planning to be pregnant, breastfeeding
- Any condition the Investigator believes would interfere with his or her ability to provide informed consent or comply with the study protocol, or which might confound
Trial locations and contacts
1 site in 1 country.
United States1 site
Clinical Nutrition Research Center
Chicago, Illinois, 60616
About this study
Official title: Polyphenols and Human Gut Microbiome Interactions: Role of in Ameliorating Inflammation
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.
Read the detailed description
The proposed study will be conducted in humans according to Good Clinical Practice (GCP) guidelines. All subjects will review and sign an Informed Consent Form approved by the Illinois Institute of Technology's Institutional Review Boards (IRB) prior to screening.
This is a single-center, randomized, single-blinded, 4-arm, placebo-controlled clinical trial. It features an acute single exposure 24-h protocol and a chronic 4-week daily intake protocol to evaluate the effects of anthocyanins and ellagitannins from strawberry and red raspberry intake compared to a control diet, FOS, or FOS and berries combined on gut inflammation, in adults with chronic low-grade inflammation.
A planned sample size of 88 will be enrolled in the study. This study will require one initial screening visit, a pre-study visit, and 5 study visits. This study will take 5 weeks per subject to complete.
The initial screening visit will provide subject with their site-specific, IRB-approved informed consent document prior to the start of any study-related procedures. Subject eligibility will be determined through a high sensitivity C-Reactive Protein (hs-CRP) marker value, anthropometric measurements, vital signs, fasting blood glucose test (finger prick), and completion of a survey related to general eating, health, mood and exercise habits.
Eligible subjects will follow a limited polyphenolic diet throughout the duration of their participation, although stricter guidelines will be imposed during the 3 days prior to a study visit that involved blood/urine/fecal collection. Shopping lists and meal plans will be provided to subjects, along with counseling by the investigator's study investigators, to help subjects adhere to the limited polyphenolic diet. The trial will initiate with a 3-day food diary to assess background (pre-study) dietary intake followed by counseling to follow a diet relatively low in (poly)phenolic rich-beverages/foods, which will be maintained for the duration of the experiment. After an initial 7-day wash-in period on the limited polyphenolic diet, subjects will be randomized to 1 of 4 treatment sequences in the form of a drink: a mixed berries diet (raspberries and strawberries), a FOS diet (non-polyphenol, carbohydrate-based fermentable fiber/pre-biotic), a combination diet (mixed berries + FOS), or a control diet (negative control). Subjects will receive the same treatment for the duration of the study. Treatment codes will be maintained by the principal investigator.
Each visit will last ~2 hours and subjects will be required to remain at the Clinical Nutrition Research Center for the duration of the visit. Fasting blood samples will be collected at the 0 and 24h time points via a butterfly needle placed by a certified phlebotomist.
- Conditions
- Overweight or Obesity, Healthy
- Being tested
- Mixed berries, FOS, Control, Combination
- Keywords
- Strawberry, Raspberry, Metabolic responses, Gut microbiome, Inflammatory markers
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mixed berriesDietary supplement
Strawberry and red raspberry
FOSDietary supplement
Fructo-oligosaccharide
ControlDietary supplement
Placebo similar in color to mixed berry supplement without any polyphenols
CombinationDietary supplement
Mixed berry composite + FOS
| Study group | Role | What they receive |
|---|---|---|
| Mixed Berries | Active comparator | Strawberry and red raspberry composite served as a frozen drink Receives: Dietary Supplement: Mixed berries |
| FOS | Active comparator | Non-polyphenol, carbohydrate-based fermentable fiber/pre-biotic served as a frozen drink Receives: Dietary Supplement: FOS |
| Combination | Active comparator | Mixed berry composite + FOS served as a frozen drink Receives: Dietary Supplement: Combination |
| Control | Placebo comparator | Placebo similar in color to mixed berry supplement without any polyphenols served as a frozen drink Receives: Dietary Supplement: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
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.
Measured: Baseline to 4 weeks
Secondary outcomes (2)
Changes in gut inflammatory markers between 4 treatments.
The concentration of calprotectin, zonulin, and IgA in fecal samples will be determined by enzyme-linked immunosorbent assay (ELISA) before and after chronic exposure to study foods.
Measured: Baseline to 4 weeks
Changes in Bile acids between 4 treatments.
Bile acids in plasma and fecal samples will be determined using UHPLC-QQQ-MS.
Measured: Baseline to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2019
- Study start7 Oct 2019
- Primary completion31 Mar 2023
- Study completion1 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight or ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinical Nutrition Research Center, Illinois Institute of Technology
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- USDA Beltsville Human Nutrition Research Center
- Responsible party
- Sponsor
- Investigators
- Amandeep Sandhu, Ph.D, Principal investigator, Institue for Food Safety and Health/Illinois Insititute of Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04100200
- Sponsor's protocol ID
- IRB2018-121
- Status last verified
- Mar 2026
- First submitted
- 18 Sep 2019
- Last updated
- 25 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Polyphenols and Human Gut Microbiome Interactions: Role of in Ameliorating Inflammation
- ClinicalTrials.gov ID
- NCT04100200
- Acronym / sponsor ID
- IRB2018-121
- Conditions
- Overweight or Obesity, Healthy
- Keywords
- Strawberry, Raspberry, Metabolic responses, Gut microbiome, Inflammatory markers
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Clinical Nutrition Research Center, Illinois Institute of TechnologyIndustry (pharma, biotech, devices)
- Collaborators
- USDA Beltsville Human Nutrition Research Center
- Study start
- 7 Oct 2019 (actual)
- Primary completion
- 31 Mar 2023 (actual)
- Study completion
- 1 Oct 2026 (estimated)
- First posted
- 24 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The proposed study will be conducted in humans according to Good Clinical Practice (GCP) guidelines. All subjects will review and sign an Informed Consent Form approved by the Illinois Institute of Technology's Institutional Review Boards (IRB) prior to screening.
This is a single-center, randomized, single-blinded, 4-arm, placebo-controlled clinical trial. It features an acute single exposure 24-h protocol and a chronic 4-week daily intake protocol to evaluate the effects of anthocyanins and ellagitannins from strawberry and red raspberry intake compared to a control diet, FOS, or FOS and berries combined on gut inflammation, in adults with chronic low-grade inflammation.
A planned sample size of 88 will be enrolled in the study. This study will require one initial screening visit, a pre-study visit, and 5 study visits. This study will take 5 weeks per subject to complete.
The initial screening visit will provide subject with their site-specific, IRB-approved informed consent document prior to the start of any study-related procedures. Subject eligibility will be determined through a high sensitivity C-Reactive Protein (hs-CRP) marker value, anthropometric measurements, vital signs, fasting blood glucose test (finger prick), and completion of a survey related to general eating, health, mood and exercise habits.
Eligible subjects will follow a limited polyphenolic diet throughout the duration of their participation, although stricter guidelines will be imposed during the 3 days prior to a study visit that involved blood/urine/fecal collection. Shopping lists and meal plans will be provided to subjects, along with counseling by the investigator's study investigators, to help subjects adhere to the limited polyphenolic diet. The trial will initiate with a 3-day food diary to assess background (pre-study) dietary intake followed by counseling to follow a diet relatively low in (poly)phenolic rich-beverages/foods, which will be maintained for the duration of the experiment. After an initial 7-day wash-in period on the limited polyphenolic diet, subjects will be randomized to 1 of 4 treatment sequences in the form of a drink: a mixed berries diet (raspberries and strawberries), a FOS diet (non-polyphenol, carbohydrate-based fermentable fiber/pre-biotic), a combination diet (mixed berries + FOS), or a control diet (negative control). Subjects will receive the same treatment for the duration of the study. Treatment codes will be maintained by the principal investigator.
Each visit will last ~2 hours and subjects will be required to remain at the Clinical Nutrition Research Center for the duration of the visit. Fasting blood samples will be collected at the 0 and 24h time points via a butterfly needle placed by a certified phlebotomist.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Mixed Berries | Active comparator | Dietary Supplement: Mixed berriesStrawberry and red raspberry composite served as a frozen drink |
| FOS | Active comparator | Dietary Supplement: FOSNon-polyphenol, carbohydrate-based fermentable fiber/pre-biotic served as a frozen drink |
| Combination | Active comparator | Dietary Supplement: CombinationMixed berry composite + FOS served as a frozen drink |
| Control | Placebo comparator | Dietary Supplement: ControlPlacebo similar in color to mixed berry supplement without any polyphenols served as a frozen drink |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mixed berriesStrawberry and red raspberry | Dietary supplement | Mixed Berries |
| FOSFructo-oligosaccharide | Dietary supplement | FOS |
| ControlPlacebo similar in color to mixed berry supplement without any polyphenols | Dietary supplement | Control |
| CombinationMixed berry composite + FOS | Dietary supplement | Combination |
Primary outcome
Changes in plasma biomarkers and measures of inflammation concentration: Nrf2/ NF-κB -response between 4 treatments
Time frame: Baseline to 4 weeks
Plasma biomarkers and measures of inflammation: Nrf2/ NF-κB activation in monocytes will be analyzed.
Changes in plasma biomarkers and measures of inflammation concentration-response between 4 treatments
Time frame: Baseline to 4 weeks
Inflammatory cytokines (Interleukin-6 (IL-6), High Sensitivity C-Reactive Protein (hs-CRP), Tumor Necrosis Factor-α (TNF-α)) will be measured.
Changes in plasma biomarkers and measures of inflammation concentration (GLP-2)-response between 4 treatments
Time frame: Baseline to 4 weeks
Analysis of GLP-2 will be done in plasma samples before and after chronic exposure to the study foods.
2 secondary outcomes
Changes in gut inflammatory markers between 4 treatments.
Time frame: Baseline to 4 weeks
Changes in Bile acids between 4 treatments.
Time frame: Baseline to 4 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amandeep Sandhu, Ph.D principal investigator
Institue for Food Safety and Health/Illinois Insititute of Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mixed berries, FOS and Combination in people with Overweight or Obesity and Healthy, run by Clinical Nutrition Research Center, Illinois Institute of Technology at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 25 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in plasma biomarkers and measures of inflammation concentration: Nrf2/ NF-κB -response between 4 treatments (time frame: Baseline to 4 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2026.