Pilot Haskap Metabolite Timing Project

NCT06938386 | Active Not Recruiting

• 1 other identifier: 2024-2029
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Diet is a key factor in managing health and individuals at risk of developing metabolic syndrome or other chronic diseases have the opportunity to use diet as a tool to improve their health. This can be complicated when considering the numerous variables that impact digestion and absorption of key health-promoting compounds in foods. One of these variables is the gut microbiome, a microbial community in the digestive tract that interacts with the foods we consume. The mechanisms the microbiome uses to interact with bioactive compounds in foods, like polyphenols, can modulate the health-promoting benefits of polyphenols. Polyphenols are secondary plant metabolites, commonly found in fruit, legumes, chocolate, coffee, and nuts among other foods that have been shown to improve cardiovascular and metabolic health, as well as reduce inflammation and oxidative stress.

Conditions

Microbial Colonization; Metabolic Disease; Digestion

Keywords

Polyphenols; Plasma metabolome; Microbial Metabolism; Metabolomics

Outcome Measures

Primary Outcomes (2)

• Metabolite Abundance

  Relative abundance of metabolites and degradation products of Haskap berries

  48 hours

• Metabolite Identity

  Identify metabolites with fragmentation MS/MS data

  48 hours

Study Arms (1)

Haskap

EXPERIMENTAL

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

Dietary Supplement: Haskap

Interventions

Haskap DIETARY_SUPPLEMENT

A whole, frozen Haskap berry puree blended with water in a 2:1 ratio of berry to water.

Haskap

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• years old
• Body mass index (BMI) between 18-30 kg/m\^2

You may not qualify if:

• allergy to Haskap berries
• have taken antibiotics in the last 90 days
• take dietary supplements
• have adverse events from blood draws
• take medication to lower cholesterol, inflammation, lipids
• smoke cigarettes
• pregnant and/or lactating
• have diabetes
• are unwilling to follow a no-polyphenolic diet for 10 days

Sponsors & Collaborators

• Montana State University: lead

Study Sites (1)

Montana State University

Bozeman, Montana, 59717, United States

Location

MeSH Terms

Conditions

Communicable Diseases; Metabolic Diseases

Condition Hierarchy (Ancestors)

Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases

Study Officials

• Mary P Miles, PhD

  Montana State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2025
• First Posted: April 22, 2025
• Study Start: May 1, 2025
• Primary Completion: June 30, 2025
• Study Completion: November 1, 2025
• Last Updated: August 19, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)