Gut Microbiota-dependent Health Impacts of Haskap Berries

Not Applicable

Recruiting

• Conditions: Metabolic Disease; Inflammation; Microbial Colonization
• Interventions: Dietary Supplement: Placebo comparator; Dietary Supplement: Haskap berry smoothie

• Registration Number: NCT06546020
• Lead Sponsor: Montana State University

Brief Summary

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.

Detailed Description

The long-term goal of this project is to form a partnership linking the health impacts of Haskap varieties and management practices that maximize health-promoting compounds to benefit both consumers and producers. Specific objectives of this study are to determine 1) the impact of Haskap on the gut microbiome and metabolome, 2) how gut microbiome composition and production of bioactive metabolites from Haskap impacts health and inflammation biomarkers, and 3) which Haskap varieties and growing practices increase production of health-promoting compounds.

To accomplish this, a four-armed, randomized, triple-blind, placebo controlled clinical trial of Haskap versus placebo for two separate groups with distinctly low and high metabolic syndrome status will be completed. Participants will be assessed for health biometrics, fat oxidation, gut microbiome composition, inflammation, and both the gut and serum metabolome before and after 8 weeks of intervention. Haskap fruit from twenty varieties will primarily come from the randomized block design field trial and fruit will be harvested at four stages of fruit maturity, then analyzed for polyphenol content. This part of the study will be replicated over three growing seasons.

Study Timeline

• Study First Submitted: 2024-08-01
• Study First Submitted QC: 2024-08-05
• Study First Posted: 2024-08-09
• Study Start: 2025-02-26
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-01
• Last Update Posted: 2025-04-02
• Primary Completion: 2027-05
• Study Completion: 2028-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

Not provided

Exclusion Criteria

• BMI <18 or > 40 kg/m^2
• potential allergy to Haskap or placebo ingredients
• use of anti-inflammatory, lipid lowering, glucose lowering, blood pressure, or any other medications that may interfere with study measures
• pregnant or lactating woman
• diagnosis with type 1 or type 2 diabetes or any other condition that may interfere with study measures
• smoke cigarettes
• have taken antibiotics in the past 90 days
• take supplements including pre/probiotics or "superfoods" within 30 days of starting the study
• are planning on starting a weight loss or exercise regiment change
• follow a specific diet such as low carbohydrate, vegan, and vegetarian
• consume over 5 servings of fruit/vegetables per day
• are unwilling to reduce caffeine intake to one 8 oz serving per day for the durations of the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo, Metabolically Healthy	Placebo comparator	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.
Haskap, Metabolically Healthy	Haskap berry smoothie	The haskap supplement will consist of a haskap berry smoothie. A twice daily dose (10-12) hours apart will be consumed for 8 weeks.
Placebo, Metabolically Unhealthy	Placebo comparator	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.
Haskap, Metabolically Unhealthy	Haskap berry smoothie	The haskap supplement will consist of a haskap berry smoothie. A twice daily dose (10-12) hours apart will be consumed for 8 weeks.

Primary Outcome Measures

Name	Time	Method
16 subunit ribosomal ribonucleic acid (16S rRNA) gut microbial composition	8 weeks	fecal microbial composition
Inflammation (pg/mL)	8 weeks	Serum interleukin (IL) IL-1B, IL-6, IL-10, IL-17, IL-23, tumor necrosis factor alpha (TNF-alpha), granulocyte-macrophage colony-stimulating factor (GM-CSF), interferon gamma (IFN-gamma)
Lipid Panel (mg/dL)	8 weeks	Serum triglycerides (TG), low-density lipoprotein (LDL) cholesterol, high-density lipoprotein (HDL) cholesterol, total cholesterol (CHOL), glucose (GLU)
F2 isoprostanes	8 weeks	urine
Untargeted metabolomic analysis	8 weeks	Fecal metabolome
Exercise Induced Fat Oxidation	8 weeks	Measurement in g/min of fat being utilized during exercise at 40-60% of the participants estimated VO2max

Secondary Outcome Measures

Name	Time	Method
Acute Diet	8 weeks	24-hour dietary recall using the Automated Self-Administered 24-hour Dietary. Assessment Tool (ASA24). Outcome is macronutrient and micronutrient composition of food entry.
Habitual Diet	Baseline	Habitual diet recall using Dietary History Questionnaire (DHQ) III (1 year recall). Outcome measures are healthy eating index (HEI) scores which include nine components based on adequacy (total fruit, whole fruit, total vegetables, greens and beans, whole grains, dairy, total protein foods, seafood and plant proteins, fatty acids) and four components based on moderation (refined grains, so-dium, added sugars, saturated fats). Each component is ranked 1-10 in order of increasing health. Total HEI score is reported as the sum of all components (100 possible points) with more points indicating increased health of diet.
Anthropometric Assessments	8 weeks	fat free mass (%)
Blood pressure	8 weeks	SBP/DBP (mmHG)
Estimated VO2 max	0 weeks	Estimation of participants VO2 max (ml/k/min) from a Fatmax test

Trial Locations

Locations (1)

Montana State University; 🇺🇸 Bozeman, Montana, United States