Montana State University
Bozeman, Montana, 59717, United States
Location status: Recruiting
Location contact
Brian Bothner, PhD
CONTACT
Mary P Miles, PhD
CONTACT
NCT Number: NCT06546020
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.
Interested in participating?
Request Info35 year–65 year
All sexes
Interventional
Not applicable
Bozeman, Montana, 59717, United States
Location status: Recruiting
Brian Bothner, PhD
CONTACT
Mary P Miles, PhD
CONTACT
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
for Metabolically Healthy Group:
All of the following:
Inclusion criteria
for Metabolically Unhealthy Group:
Required:
AND ≥ 1 of the following:
Exclusion criteria
A smoothie blend of berries and water
A smoothie with no polyphenolic content and matched in carbohydrate composition to the experimental haskap smoothie
Time frame: 8 weeks
fecal microbial composition
Time frame: 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)
Time frame: 8 weeks
Serum triglycerides (TG), low-density lipoprotein (LDL) cholesterol, high-density lipoprotein (HDL) cholesterol, total cholesterol (CHOL), glucose (GLU)
Time frame: 8 weeks
urine
Time frame: 8 weeks
Serum metabolome
Time frame: 8 weeks
Fecal metabolome
Time frame: 8 weeks
Measurement in g/min of fat being utilized during exercise at 40-60% of the participants estimated VO2max
Time frame: 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.
Time frame: 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.
Time frame: 8 weeks
waist circumference (cm)
Time frame: 8 weeks
visceral adipose (L)
Time frame: 8 weeks
BMI (kg/m2)
Time frame: 8 weeks
fat free mass (%)
Time frame: 8 weeks
SBP/DBP (mmHG)
Time frame: 0 weeks
Estimation of participants VO2 max (ml/k/min) from a Fatmax test
Contact information is provided by the study sponsor or research team.
Mary P Miles, PhD
CONTACT
Zachary T Miller, PhD
CONTACT
Montana State University
Other
PARTNERSHIP: Elucidating Gut Microbiota-dependent Health Impacts of Haskap Berries to Inform Agricultural Production Practices That Will Maximize Bioactive Potential
Acronym: HIH
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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