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Mixed Berries for Obesity

N/A
Waitlist Available
Led By Amandeep Sandhu, Ph.D
Research Sponsored by Clinical Nutrition Research Center, Illinois Institute of Technology
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 4 weeks
Awards & highlights

Study Summary

This trial is testing the effects of anthocyanins and ellagitannins from strawberries and red raspberries on indices of systemic and gut inflammation, as well as host- and microbial-derived metabolite pools.

Who is the study for?
This trial is for adults aged 20-60 with a BMI ≥ 25 kg/m2 and low-grade inflammation (hs-CRP > 1.0 and ≤ 10 ng/L). Participants should be in good health, not have major diseases like CVD or diabetes, and must not take medications or supplements that affect the study. They can't be smokers, heavy drinkers, extreme athletes, pregnant women, or have unstable diets.Check my eligibility
What is being tested?
The study tests how mixed berries (strawberry and red raspberries), FOS (a fiber/pre-biotic), alone or combined affect gut inflammation and microbiome after one day and four weeks compared to a control diet. It looks at changes in metabolites and inflammatory markers linked to gut microbial activity.See study design
What are the potential side effects?
Potential side effects are not explicitly listed but may include digestive discomfort due to dietary changes. Allergies could occur if participants react to berry components.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 4 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 4 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Changes in plasma biomarkers and measures of inflammation concentration (GLP-2)-response between 4 treatments
Changes in plasma biomarkers and measures of inflammation concentration-response between 4 treatments
Body Weight Changes
Secondary outcome measures
Bile Acids
Changes in gut inflammatory markers between 4 treatments.
Other outcome measures
Urine

Trial Design

4Treatment groups
Active Control
Placebo Group
Group I: Mixed BerriesActive Control1 Intervention
Strawberry and red raspberry composite served as a frozen drink
Group II: FOSActive Control1 Intervention
Non-polyphenol, carbohydrate-based fermentable fiber/pre-biotic served as a frozen drink
Group III: CombinationActive Control1 Intervention
Mixed berry composite + FOS served as a frozen drink
Group IV: ControlPlacebo Group1 Intervention
Placebo similar in color to mixed berry supplement without any polyphenols served as a frozen drink

Find a Location

Who is running the clinical trial?

Clinical Nutrition Research Center, Illinois Institute of TechnologyLead Sponsor
53 Previous Clinical Trials
2,815 Total Patients Enrolled
USDA Beltsville Human Nutrition Research CenterFED
54 Previous Clinical Trials
5,176 Total Patients Enrolled
5 Trials studying Obesity
506 Patients Enrolled for Obesity
Amandeep Sandhu, Ph.DPrincipal InvestigatorInstitue for Food Safety and Health/Illinois Insititute of Technology

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who else is applying?

What state do they live in?
Illinois
How old are they?
18 - 65
What site did they apply to?
Clinical Nutrition Research Center
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Berries, Inflammation, and Gut Microbiome
2019. "Berries, Inflammation, and Gut Microbiome". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04100200.
All > Microbiome
~19 spots leftby Apr 2025
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