Haskap Berries for Gut Health

(HIH Trial)

Overseen By Zachary T Miller, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Montana State University

Must not be taking: Anti-inflammatory, Lipid lowering, Glucose lowering, Blood pressure

Disqualifiers: Diabetes, BMI <18 or >40, others

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

120 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

Yes, you will need to stop taking any anti-inflammatory, lipid lowering, glucose lowering, blood pressure, or other medications that might interfere with the study.

What data supports the effectiveness of the treatment Haskap Berries for gut health?

Research on other berries, like blackcurrants and Saskatoon berries, shows they can improve gut health by altering gut bacteria and reducing inflammation. These effects suggest that Haskap Berries might also support gut health in a similar way. ^{1 2 3 4 5}

Is it safe to consume Haskap berries for gut health?

Research indicates that Haskap berries, rich in anthocyanins, are considered safe for consumption, as studies have shown no microbial contamination or harmful effects on non-tumor cells. ^{6 7 8 9 10}

How do Haskap berries differ from other treatments for gut health?

Haskap berries are unique for gut health due to their high content of anthocyanins and phenolic compounds, which have anti-inflammatory and antimicrobial properties. These natural compounds can help reduce inflammation and combat harmful bacteria in the gut, offering a novel approach compared to traditional treatments. ^{3 6 7 8 9}

What is the purpose of this trial?

Polyphenol-rich Haskap berries (Haskap) have untapped therapeutic potential to improve human health, and agricultural producers in northern U.S. states are poised to increase production if consumer demand increases. A critical knowledge gap is that little is known about the interactions between gut microbes and Haskap polyphenols to produce bioactive metabolites linked to downstream health impacts. Additionally, little is known about which Haskap varieties and harvest timing yield the greatest bioactive potential. This study aims to address these gaps by investigating the interaction of bioactive components in Haskap with gut microbiota and the resultant gut and serum metabolites, inflammation, and metabolic health, and then couple this with analysis of berries from different Haskap varieties and harvest times.

Research Team

Mary P Miles, PhD

Principal Investigator

Montana State University

Eligibility Criteria

This trial is for individuals with specific health measurements: men must have a waist circumference ≤ 40 inches and women ≤ 35 inches, blood pressure ≤ 130/85 mmHg, fasting glucose ≤ 100 mg/dl, triglycerides ≤ 150 mg/dl, and HDL cholesterol >40 mg/dl for men and >50 mg/dl for women.

Inclusion Criteria

My blood pressure is 130 mmHg or lower.

My diastolic blood pressure is 85 mmHg or lower.

My fasting triglycerides are 150 mg/dL or lower.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either a Haskap berry smoothie or a placebo twice daily for 8 weeks

8 weeks

Regular visits for health biometrics and sample collection

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Haskap Berries

Trial Overview The study tests the health effects of Haskap berry smoothies on gut microbiota and inflammation compared to a placebo. It will also analyze how different varieties and harvest times of Haskap berries affect these outcomes.

Participant Groups

Group I: Haskap, Metabolically Unhealthy Experimental Treatment 1 Intervention

The haskap supplement will consist of a haskap berry smoothie. A twice daily dose (10-12) hours apart will be consumed for 8 weeks.

Group II: Haskap, Metabolically Healthy Experimental Treatment 1 Intervention

The haskap supplement will consist of a haskap berry smoothie. A twice daily dose (10-12) hours apart will be consumed for 8 weeks.

Group III: Placebo, Metabolically Unhealthy Placebo Group 1 Intervention

The placebo supplement will have no polyphenol content and will be carbohydrate-matched to the experimental group. A twice daily dose (10-12 hours apart) will be consumed for 8 weeks.

Group IV: Placebo, Metabolically Healthy Placebo Group 1 Intervention

The placebo supplement will have no polyphenol content and will be carbohydrate-matched to the experimental group. A twice daily dose (10-12 hours apart) will be consumed for 8 weeks.

Who Is Running the Clinical Trial?

Montana State University

Lead Sponsor

Trials

47

Recruited

1,044,000+

Montana State Agricultural Experiment Station

Collaborator

Trials

1

Recruited

120+

Findings from Research

Rats fed anthocyanin-rich blackcurrant extract for six weeks showed significantly less body weight gain and reduced food intake compared to those on control diets, indicating potential benefits for weight management.

Combining blackcurrant extract with dietary fibers enhanced the positive effects on large intestinal health, as evidenced by changes in gut bacteria and increased production of beneficial short-chain fatty acids like propionic and butyric acids.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Blackcurrant and Dietary Fibers on Large Intestinal Health Biomarkers in Rats. Paturi, G., Butts, CA., Monro, JA., et al.[2018]

Berries have been shown to provide significant health benefits for the digestive tract, including support for the immune system and beneficial effects on gut microbiota, based on in vivo studies.

Whole berry extracts are more effective than individual components in reducing premalignant and malignant lesions, suggesting that berries could be a valuable addition to treatments for gastrointestinal and immune-related conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Review of the health effects of berries and their phytochemicals on the digestive and immune systems. Govers, C., Berkel Kasikci, M., van der Sluis, AA., et al.[2019]

Phenolic compounds from Finnish berries, particularly myricetin, showed strong antimicrobial activity against lactic acid bacteria but did not inhibit the pathogenic Salmonella strain, indicating selective antimicrobial properties.

Berry extracts, especially from cloudberries, raspberries, and strawberries, effectively inhibited the growth of Gram-negative bacteria like Salmonella, suggesting their potential use in functional foods and as natural preservatives.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Antimicrobial properties of phenolic compounds from berries. Puupponen-Pimiä, R., Nohynek, L., Meier, C., et al.[2022]

Cloudberries, rich in ellagitannins, were found to reduce intestinal adenoma size in mice by attenuating inflammation and altering gut microbiota, suggesting a protective effect against tumor growth.

In contrast, bilberries, which are high in anthocyanins, did not change lymphocyte density and were associated with increased bacterial diversity, but they led to larger adenomas, indicating a different impact on intestinal health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Changes in intestinal immunity, gut microbiota, and expression of energy metabolism-related genes explain adenoma growth in bilberry and cloudberry-fed ApcMin mice. Päivärinta, E., Niku, M., Maukonen, J., et al.[2018]

Saskatoon berry powder (SBp) significantly reduced body weight gain and improved metabolic and inflammatory markers in diet-induced obese mice over a 15-week period, indicating its potential as a dietary intervention for obesity-related disorders.

The study found that SBp altered the gut microbiota composition, specifically lowering the Firmicutes/Bacteroidetes ratio, which is associated with improved metabolic health and reduced inflammation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of Saskatoon berry powder on insulin resistance and relationship with intestinal microbiota in high fat-high sucrose diet-induced obese mice. Zhao, R., Khafipour, E., Sepehri, S., et al.[2020]

The study found that Canadian haskap berry extracts, particularly from the Borealis cultivar, have high levels of beneficial polyphenols and can significantly reduce pro-inflammatory cytokines in human macrophages, suggesting their potential as natural anti-inflammatory agents.

Borealis haskap extracts demonstrated anti-inflammatory effects comparable to the COX inhibitory drug diclofenac, indicating that these berry polyphenols could be effective in managing inflammation-related conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anti-Inflammatory Activity of Haskap Cultivars is Polyphenols-Dependent. Rupasinghe, HP., Boehm, MM., Sekhon-Loodu, S., et al.[2019]

In a study involving 30 male recreational runners, consuming Haskap berries led to a significant improvement in 5 km running performance by approximately 21 seconds, equating to over a 2% increase in speed compared to a placebo.

Participants in the Haskap group also experienced a longer time to exhaustion during peak oxygen consumption tests, suggesting that Haskap berries may enhance endurance and recovery in exercise.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improved Endurance Running Performance Following Haskap Berry (Lonicera caerulea L.) Ingestion. Howatson, G., Snaith, GC., Kimble, R., et al.[2023]

Haskap berries are rich in anthocyanins and other beneficial compounds, showing strong antioxidant and antimicrobial properties, making them a valuable nutritional source.

The colorants derived from haskap juice are stable for 12 weeks and safe for consumption, suggesting their potential use as natural alternatives to artificial colorants in the food industry and beyond.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Promising Antioxidant and Antimicrobial Food Colourants from Lonicera caerulea L. var. Kamtschatica. Molina, AK., Vega, EN., Pereira, C., et al.[2020]

A study involving 20 older adults found that a 400 mg dose of haskap berry extract significantly improved episodic memory performance and reduced diastolic blood pressure compared to a placebo.

The results suggest that higher doses of haskap berries, rich in anthocyanins, are effective in enhancing cognitive function, particularly in word recall and recognition, while also indicating a potential vasodilatory effect on blood pressure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pilot dose-response study of the acute effects of haskap berry extract (Lonicera caerulea L.) on cognition, mood, and blood pressure in older adults. Bell, L., Williams, CM.[2021]

Berry-derived dietary fibers and polyphenols can significantly influence gut microbiota composition, promoting gastrointestinal health and potentially reducing metabolic risk factors.

Selecting specific berries can help prevent gastrointestinal inflammation and improve metabolic outcomes by providing beneficial substrates for microbiota and modulating gut health through various mechanisms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Berries in Microbiome-Mediated Gastrointestinal, Metabolic, and Immune Health. Komarnytsky, S., Wagner, C., Gutierrez, J., et al.[2023]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Effects of Blackcurrant and Dietary Fibers on Large Intestinal Health Biomarkers in Rats. [2018]

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

Review of the health effects of berries and their phytochemicals on the digestive and immune systems. [2019]

3. England pubmed.ncbi.nlm.nih.gov

Antimicrobial properties of phenolic compounds from berries. [2022]

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

Changes in intestinal immunity, gut microbiota, and expression of energy metabolism-related genes explain adenoma growth in bilberry and cloudberry-fed ApcMin mice. [2018]

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

Impact of Saskatoon berry powder on insulin resistance and relationship with intestinal microbiota in high fat-high sucrose diet-induced obese mice. [2020]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Anti-Inflammatory Activity of Haskap Cultivars is Polyphenols-Dependent. [2019]

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

Improved Endurance Running Performance Following Haskap Berry (Lonicera caerulea L.) Ingestion. [2023]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Promising Antioxidant and Antimicrobial Food Colourants from Lonicera caerulea L. var. Kamtschatica. [2020]

9. Germany pubmed.ncbi.nlm.nih.gov

A pilot dose-response study of the acute effects of haskap berry extract (Lonicera caerulea L.) on cognition, mood, and blood pressure in older adults. [2021]

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

Berries in Microbiome-Mediated Gastrointestinal, Metabolic, and Immune Health. [2023]