Haskap for Digestion

(PHMTiming Trial)

Overseen By Meghan Spears, MSc

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Montana State University

Must not be taking: Cholesterol, Inflammation, Lipids

Disqualifiers: Allergy, Antibiotics, Supplements, Smoking, Diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 48 hours

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the effects of Haskap berries on digestion and overall health. Researchers aim to understand how these berries, rich in polyphenols (compounds in foods like fruits and nuts that support health), interact with the gut microbiome (the community of microbes in the digestive system) to improve or maintain health. Individuals with a BMI between 18 and 30 who haven't recently taken antibiotics or certain medications might be suitable candidates. Participants will consume Haskap puree after providing a fasting blood sample. As an unphased study, this trial offers a unique opportunity to contribute to scientific understanding and potentially enhance personal health through natural dietary interventions.

Will I have to stop taking my current medications?

If you take medication to lower cholesterol, inflammation, or lipids, you will need to stop taking them to participate in this trial.

What prior data suggests that Haskap is safe for digestion?

Research shows that Haskap berries are safe to eat. Rich in natural compounds called anthocyanins, these berries offer health benefits. Studies have found no harmful germs or contaminants in them. While more research is needed to fully understand all benefits and any possible risks, current evidence suggests that Haskap berries are generally well-tolerated by the body. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Haskap is unique because it's a natural option that focuses on improving digestion with a fruit-based approach. Unlike standard treatments that often involve medications or supplements, Haskap uses a puree made from the haskap berry, which is rich in antioxidants and has potential digestive benefits. Researchers are excited about its potential to enhance gut health with a simple, food-based intervention, offering a more holistic and less invasive alternative to traditional therapies.

What evidence suggests that Haskap might be an effective treatment for digestion?

Research has shown that Haskap berries might improve health by reducing stress and inflammation in the body. Rich in polyphenols, these natural compounds can benefit heart and metabolic health. Studies have found that Haskap berries also support gut health by positively affecting digestive bacteria. Additionally, evidence suggests these berries might help prevent some obesity-related health issues. In this trial, all participants will consume Haskap puree to evaluate its effects on digestion and overall health. Overall, Haskap berries appear to be a natural way to support digestion and overall health. ^{1 5 6 7 8}

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 at risk of metabolic syndrome or other chronic diseases, who are interested in using diet to improve their health. It focuses on how the gut microbiome interacts with polyphenols from foods like fruit and nuts.

Inclusion Criteria

Body mass index (BMI) between 18-30 kg/m^2

Exclusion Criteria

I take medication for cholesterol, inflammation, or lipids.

Smoke cigarettes

I have taken antibiotics within the last 3 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants consume Haskap puree after a fasting blood sample is collected

48 hours

1 visit (in-person)

Follow-up

Participants are monitored for metabolite identity and abundance after Haskap consumption

1 week

What Are the Treatments Tested in This Trial?

Interventions

• Haskap

Trial Overview The study tests the effects of Haskap, a berry rich in polyphenols, on microbial colonization and metabolism. The goal is to understand how timing affects the absorption and benefits of these compounds.

How Is the Trial Designed?

Group I: Haskap Experimental Treatment 1 Intervention

Haskap puree will be consumed by all participants after a fasting blood sample is collected

Who Is Running the Clinical Trial?

Montana State University

Lead Sponsor

Trials

47

Recruited

1,044,000+

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. 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 ...

4. 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 ...

5. mdpi.com mdpi.com/2072-6643/14/19/3898

Haskap Berry Leaves (Lonicera caerulea L.) The presented research evaluates the medical use potential of Lonicera caerulea leaves, which are waste plants in cultivating berries.

6. 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 ... ), we propose an analysis that will compare gutmicrobiota and health impacts of Haskap berry consumption between metabolicallyhealthy and unhealthy groups.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9573050/

Haskap Berry Leaves (Lonicera caerulea L.) The microbiological analysis confirmed the safety of using Lonicera caerulea leaves without significant stabilization. Lonicera caerulea leaves standardization ...

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

The potential health benefits of haskap (Lonicera caerulea L.) It is believed that haskap has been used in folk medicine to reduce the risk of hypertension, glaucoma, heart attack, anemia, malaria, osteoporosis, and ...