RECRUITING

Gut Microbiota-dependent Health Impacts of Haskap Berries

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

PARTNERSHIP: Elucidating Gut Microbiota-dependent Health Impacts of Haskap Berries to Inform Agricultural Production Practices That Will Maximize Bioactive Potential

Quick Facts

Study Start:2025-02-26
Study Completion:2028-05
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06546020

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:35 Years to 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. * BMI \<18 or \> 40 kg/m\^2
  2. * potential allergy to Haskap or placebo ingredients
  3. * use of anti-inflammatory, lipid lowering, glucose lowering, blood pressure, or any other medications that may interfere with study measures
  4. * pregnant or lactating woman
  5. * diagnosis with type 1 or type 2 diabetes or any other condition that may interfere with study measures
  6. * smoke cigarettes
  7. * have taken antibiotics in the past 90 days
  8. * take supplements including pre/probiotics or "superfoods" within 30 days of starting the study
  9. * are planning on starting a weight loss or exercise regiment change
  10. * follow a specific diet such as low carbohydrate, vegan, and vegetarian
  11. * consume over 5 servings of fruit/vegetables per day
  12. * are unwilling to reduce caffeine intake to one 8 oz serving per day for the durations of the study

Contacts and Locations

Study Contact

Mary P Miles, PhD
CONTACT
406-994-6678
mmiles@montana.edu
Zachary T Miller, PhD
CONTACT
(406) 961-3025
zachariah.miller@montana.edu

Principal Investigator

Mary P Miles, PhD
PRINCIPAL_INVESTIGATOR
Montana State University

Study Locations (Sites)

Montana State University
Bozeman, Montana, 59717
United States

Collaborators and Investigators

Sponsor: Montana State University

  • Mary P Miles, PhD, PRINCIPAL_INVESTIGATOR, Montana State University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-02-26
Study Completion Date2028-05

Study Record Updates

Study Start Date2025-02-26
Study Completion Date2028-05

Terms related to this study

Keywords Provided by Researchers

  • Microbial metabolism
  • Gut microbial composition
  • Serum metabolome
  • Polyphenols

Additional Relevant MeSH Terms

  • Metabolic Disease
  • Inflammation
  • Microbial Colonization