Gut Microbiota-dependent Health Impacts of Haskap Berries
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age35-65
SponsorMontana State University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Waist circumference: men ≤ 40, women ≤ 35 inches
Systolic blood pressure: ≤ 130 mmHg
Diastolic blood pressure: ≤ 85 mmHg
Fasting glucose: ≤ 100 mg·dl-1
Disqualifiers
BMI <18 or > 40 kg/m²
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
Trial design
Design model
Parallel
Treatments tested in this trial
Haskap berry smoothie
Dietary supplementA smoothie blend of berries and water
Placebo comparator
Dietary supplementA smoothie with no polyphenolic content and matched in carbohydrate composition to the experimental haskap smoothie
Treatment groups
120 Participants
are divided into 4 treatment groupsGroup A: Placebo, Metabolically HealthyPlacebo comparator 1 intervention
Group B: Haskap, Metabolically HealthyExperimental treatment 1 intervention
Group C: Placebo, Metabolically UnhealthyPlacebo comparator 1 intervention
Group D: Haskap, Metabolically UnhealthyExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
16 subunit ribosomal ribonucleic acid (16S rRNA) gut microbial composition
fecal microbial composition
Time frame
8 weeks2
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)
Time frame
8 weeks3
Lipid Panel (mg/dL)
Serum triglycerides (TG), low-density lipoprotein (LDL) cholesterol, high-density lipoprotein (HDL) cholesterol, total cholesterol (CHOL), glucose (GLU)
Time frame
8 weeks4
F2 isoprostanes
urine
Time frame
8 weeksSecondary outcomes
1
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.
Time frame
8 weeks2
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.
Time frame
Baseline3
Anthropometric Assessments
waist circumference (cm)
Time frame
8 weeks4
Anthropometric Assessments
visceral adipose (L)
Time frame
8 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Montana State University
Lead sponsor
Montana State Agricultural Experiment Station
Collaborator
Source ClinicalTrials.gov