Berries for Inflammation

Overseen By Indika Edirisinghe, Ph.D

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Clinical Nutrition Research Center, Illinois Institute of Technology

Must not be taking: Lipid-lowering, Anti-inflammatory, Probiotics, others

Disqualifiers: Smoking, Cardiovascular disease, Diabetes, Cancer, others

Compensation: Varies

Number of Visits: 7

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how certain compounds in strawberries and red raspberries might affect inflammation in the body and gut. Researchers compare the effects of a berry drink, a fiber drink, a combination of both (referred to as "Combination"), and a placebo drink. They aim to determine if these drinks can alter inflammation and gut health in individuals with low-grade inflammation. The study seeks participants who are in good health, have a body mass index (BMI) of 25 or higher, and maintain stable lifestyle habits, such as consistent diet and exercise routines. As an unphased trial, this study offers a unique opportunity to contribute to the scientific understanding of natural compounds and their potential health benefits.

Will I have to stop taking my current medications?

The trial requires that you do not take any medications or supplements that could interfere with the study outcomes, such as lipid-lowering medications or anti-inflammatory drugs. If you are on such medications, you may need to stop taking them to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that eating berries is generally safe and may offer health benefits, such as reducing inflammation and stress in the body. Studies highlight their antioxidant properties, which help protect the body from damage caused by free radicals—unstable molecules that can lead to inflammation.

For FOS (fructooligosaccharides), research indicates it is generally considered safe. FOS, a type of fiber, supports gut health by nourishing beneficial bacteria. However, some people might experience mild side effects like gas or stomach discomfort.

Existing studies have not identified any specific safety concerns with the combination of mixed berries and FOS. Both have a history of being well-tolerated. Overall, current research considers both treatments safe. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the treatments involving mixed berries and a combination of berries with FOS because they offer a natural approach to managing inflammation. Unlike standard anti-inflammatory drugs, which often rely on synthetic compounds, these treatments use natural polyphenols found in strawberries and red raspberries. The combination treatment also includes FOS, a prebiotic fiber that may enhance gut health, potentially offering a dual benefit. This natural intervention could provide a gentler, more holistic alternative to current options, appealing to those seeking plant-based remedies.

What evidence suggests that this trial's treatments could be effective for inflammation?

This trial will compare the effects of different treatments on inflammation. Participants may receive a mixed berries treatment, including strawberries and red raspberries, known for natural compounds that reduce inflammation by blocking certain pathways. Another group will receive FOS (fructooligosaccharides), a type of prebiotic fiber. Studies have found that FOS can increase beneficial gut bacteria like Bifidobacterium, which is linked to reducing inflammation. Additionally, some participants will receive a combination of mixed berries and FOS, which might enhance anti-inflammatory effects. Some studies suggest that probiotics and berry extracts together can boost these benefits. A control group will receive a placebo similar in color to the mixed berry supplement but without any polyphenols. ^{1 2 6 7 8}

Who Is on the Research Team?

Amandeep Sandhu, Ph.D

Principal Investigator

Institue for Food Safety and Health/Illinois Insititute of Technology

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

You are judged to be in general good health.

C-Reactive Protein (hs-CRP) > 1.0 and ≤ 10 ng/L

Aged 20-60 years

Exclusion Criteria

Taking any medications and/or supplements that would interfere with outcomes of the study (i.e., lipid-lowering medications, anti-inflammatory drugs, etc)

Have been exposed to any non-registered drug product within last 30 days

You currently smoke cigarettes or use marijuana.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (in-person)

Pre-study

Participants complete a 3-day food diary and receive counseling to follow a limited polyphenolic diet

1 week

1 visit (in-person)

Treatment

Participants are randomized to one of four treatment sequences and consume the assigned diet for 4 weeks

4 weeks

5 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Combination
• Control
• FOS
• Mixed berries

Trial Overview 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.

How Is the Trial Designed?

Group I: Mixed Berries Active Control 1 Intervention

Strawberry and red raspberry composite served as a frozen drink

Group II: FOS Active Control 1 Intervention

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

Group III: Combination Active Control 1 Intervention

Mixed berry composite + FOS served as a frozen drink

Group IV: Control Placebo Group 1 Intervention

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

Who Is Running the Clinical Trial?

Clinical Nutrition Research Center, Illinois Institute of Technology

Lead Sponsor

Trials

55

Recruited

3,000+

USDA Beltsville Human Nutrition Research Center

Collaborator

Trials

56

Recruited

5,300+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04100200?term=berries+AND+cancer&viewType=Table&rank=2

NCT04100200 | Berries, Inflammation, and Gut Microbiome The primary objectives are to characterize changes in indices of systemic and gut inflammation, assess host- and microbial-derived metabolite pools, ...

2. withpower.com withpower.com/trial/phase-overweight-9-2019-8c404

Berries for Inflammation · Info for Participants The mixed berries treatment is unique because it uses natural compounds found in berries to reduce inflammation by inhibiting specific inflammatory pathways, ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7912458/

Berries as a Treatment for Obesity-Induced Inflammation Berries contain an abundance of bioactive compounds that have been shown to inhibit inflammation and to reduce reactive oxygen species.

4. sciencedirect.com sciencedirect.com/science/article/pii/S1756464622001918

Combination of different probiotics and berry-derived (poly) ... Association of probiotics and berry polyphenolic extracts can enhance the anti-inflammatory effects. •. Select and characterize a combination of specific ...

5. clinicaltrial.be clinicaltrial.be/fr/details/61210?active_not_recruiting=1&completed=0&enrolling_by_invitation=1&only_active=0&only_eligible=0&only_recruiting=0&per_page=100

Berries, Inflammation, and Gut Microbiome - Découvrir fac... This is a single-center, randomized, single-blinded, 4-arm, placebo-controlled clinical trial. It features an acute single exposure 24-h ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10097348/

Mixed Berry Juice and Cellulose Fiber Have Differential ... Different components of berries, specifically anthocyanins/flavonoids and fiber, appear to have differential effects on cellular respiration.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5687726/

Effects of a mixed berry beverage on cognitive functions and ... The aim of this study was to evaluate effects on cognitive functions and cardiometabolic risk markers of 5 wk intervention with a mixture of berries, in ...

8. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT02370966?intr=Sea+buckthorn&rank=10

Berry Intake - Effects on Systemic and Oral Inflammation ... Summary About 10-15 % of the adult population in Sweden suffers from periodontitis, which is an inflammatory response to certain oral bacteria.