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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how Haskap berries might improve gut health. Researchers aim to determine if these berries, rich in beneficial compounds called polyphenols, interact with gut bacteria to enhance health. Participants will consume either a Haskap berry smoothie or a placebo (a substance with no active ingredients) to compare effects. The trial is open to individuals who can easily verify if their waist size is above or below a certain measurement, along with other specific health markers.

As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research on natural health solutions.

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.

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

Research has shown that Haskap berries are safe to eat. These berries are rich in anthocyanins, nutrients known for their health benefits. Studies have found no harmful effects or contamination from consuming these berries. Haskap berries may protect cells from damage, support heart and brain health, reduce swelling, and help manage blood sugar. These findings suggest that Haskap berries are generally well-tolerated and safe for consumption. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using haskap berries for gut health because they offer a natural, berry-based approach that could improve metabolic health. Unlike traditional treatments that often involve medication or dietary supplements with synthetic ingredients, haskap berries are rich in polyphenols, which are natural compounds known for their antioxidant properties. This means they might help reduce inflammation and support gut health in a more organic way. Plus, the treatment is delivered through a smoothie, making it an easy and enjoyable option for participants.

What evidence suggests that Haskap berries could be effective for gut health?

Research has shown that Haskap berries are rich in polyphenols, natural compounds that can enhance gut health by interacting with digestive system bacteria. These berries have also been found to reduce oxidative stress, a harmful condition linked to diseases like diabetes. One study suggested that Haskap berries might help prevent obesity-related health issues. The beneficial compounds in the berries become more effective after processing by gut bacteria, potentially leading to health benefits. This trial will compare the effects of Haskap berries with a placebo in both metabolically healthy and unhealthy participants. Overall, Haskap berries may improve gut and metabolic health, but further research is needed to fully understand their effects. ^{1 2 4 6 7}

Who Is on the Research Team?

Mary P Miles, PhD

Principal Investigator

Montana State University

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10968585/

Exploring Beneficial Properties of Haskap Berry Leaf ... By reducing oxidative stress, haskap berry leaves may offer protective effects against complications associated with diabetes, contributing to ...

2. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/86/NCT06938386/ICF_000.pdf

Pilot Haskap Metabolite Timing Project Dr. Mary Miles NCT reaching the blood stream after gut microbiome digestion may help us obtain a better understanding of the effectiveness of Haskap berries to improve health.

3. nal.usda.gov nal.usda.gov/research-tools/food-safety-research-projects/partnership-elucidating-gut-microbiota-dependent-health-impacts-haskap-berries-inform-agricultural

ELUCIDATING GUT MICROBIOTA-DEPENDENT HEALTH ... Polyphenol-rich Haskap berries (Haskap) have untapped therapeutic potential to improvehuman health, and agricultural producers in northern U.S. states are ...

4. withpower.com withpower.com/trial/phase-inflammation-9-2024-46a1c

Haskap Berries for Gut Health (HIH Trial) 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 ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S1756464623002359

Supplementation of cyanidin-3-O-β-glucoside-rich haskap ... In the present study, we investigated the prospect of C3G-rich haskap berry extract (CE) to prevent metabolic and functional outcomes in diet-induced obesity ...

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1756464618300689

The potential health benefits of haskap (Lonicera caerulea L.) Haskap has potential antioxidant, cardio-protective, anti-inflammatory, neuroprotective, anticancer, and anti-diabetic properties, and may help with chronic ...

7. mdpi.com mdpi.com/1422-0067/26/14/6618

Bioactive Compounds and In Vitro Health-Promoting ... The health-promoting properties of haskap berries have recently been widely analyzed. Some studies have shown in vivo cardioprotective and neuroprotective ...