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

105 Participants Needed

Trial Summary

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 it safe to consume berries for inflammation treatment?

Research suggests that consuming berries is generally safe and may offer health benefits, including reducing inflammation and oxidative stress. Berries contain natural compounds that have been studied for their positive effects on health, and no significant safety concerns have been reported in the studies reviewed. ^{1 2 3 4 5}

How does the mixed berries treatment for inflammation differ from other treatments?

The mixed berries treatment is unique because it uses natural compounds found in berries to reduce inflammation by inhibiting specific inflammatory pathways, such as NF-κB, and reducing oxidative stress. Unlike conventional anti-inflammatory drugs, this treatment leverages the bioactive components of berries, which have shown potential in preclinical studies to address inflammation associated with obesity and other chronic conditions. ^{4 6 7 8 9}

What is the purpose of this trial?

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.

Research Team

Amandeep Sandhu, Ph.D

Principal Investigator

Institue for Food Safety and Health/Illinois Insititute of Technology

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

References

1. United States pubmed.ncbi.nlm.nih.gov

The berry health tool chest - an evidence map and interactive resource. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Emerging research supporting the positive effects of berries on human health and disease prevention. [2014]

3. United States pubmed.ncbi.nlm.nih.gov

Berry fruits for cancer prevention: current status and future prospects. [2011]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Berries as a Treatment for Obesity-Induced Inflammation: Evidence from Preclinical Models. [2021]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Select Polyphenol-Rich Berry Consumption to Defer or Deter Diabetes and Diabetes-Related Complications. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Antioxidant and anti-inflammatory activities of polyphenolics from Southeastern U.S. range blackberry cultivars. [2013]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Berry Phenolic and Volatile Extracts Inhibit Pro-Inflammatory Cytokine Secretion in LPS-Stimulated RAW264.7 Cells through Suppression of NF-κB Signaling Pathway. [2020]

8. Canada pubmed.ncbi.nlm.nih.gov

Anti-inflammatory and wound healing properties of polyphenolic extracts from strawberry and blackberry fruits. [2020]

9. United States pubmed.ncbi.nlm.nih.gov

Berry anthocyanins suppress the expression and secretion of proinflammatory mediators in macrophages by inhibiting nuclear translocation of NF-κB independent of NRF2-mediated mechanism. [2022]