Gut Microbiota-dependent Health Impacts of Haskap Berries
NCT Number: NCT06546020
Acronym: HIH
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Metabolic Disease|Inflammation|Microbial Colonization
Interventions: DIETARY_SUPPLEMENT: Haskap berry smoothie|DIETARY_SUPPLEMENT: Placebo comparator
Sponsor: Montana State University
Collaborators: Montana State Agricultural Experiment Station
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 120
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: PREVENTION
Start Date: 2024-10
Completion Date: 2028-05

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.

Primary Outcome Measures: 16 subunit ribosomal ribonucleic acid (16S rRNA) gut microbial composition, fecal microbial composition, 8 weeks|Inflammation (pg/mL), 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), 8 weeks|Lipid Panel (mg/dL), Serum triglycerides (TG), low-density lipoprotein (LDL) cholesterol, high-density lipoprotein (HDL) cholesterol, total cholesterol (CHOL), glucose (GLU), 8 weeks|F2 isoprostanes, urine, 8 weeks|Untargeted metabolomic analysis, Serum metabolome, 8 weeks|Untargeted metabolomic analysis, Fecal metabolome, 8 weeks
Secondary Outcome Measures: Acute Diet, 24-hour dietary recall using the Automated Self-Administered 24-hour Dietary. Assessment Tool (ASA24). Outcome is macronutrient and micronutrient composition of food entry., 8 weeks|Habitual Diet, 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., Baseline|Anthropometric Assessments, waist circumference (cm), 8 weeks|Anthropometric Assessments, visceral adipose (L), 8 weeks|Anthropometric Assessments, BMI (kg/m2), 8 weeks|Anthropometric Assessments, fat free mass (%), 8 weeks|Blood pressure, SBP/DBP (mmHG), 8 weeks