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NCT Number: NCT06546020

Gut Microbiota-dependent Health Impacts of Haskap Berries

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.

Recruiting

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Key information

Age range

35 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

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:

  • Waist circumference: men ≤ 40, women ≤ 35 inches
  • Systolic blood pressure: ≤ 130 mmHg
  • Diastolic blood pressure: ≤ 85 mmHg
  • Fasting glucose: ≤ 100 mg·dl-1
  • Fasting triglycerides: ≤ 150 mg·dl-1
  • HDL: men > 40, women > 50 mg·dl-1

Inclusion criteria

for Metabolically Unhealthy Group:

Required:

  • Waist circumference: men ≥ 40, women ≥ 35 inches

AND ≥ 1 of the following:

  • Systolic blood pressure: > 130 mmHg
  • Diastolic blood pressure: > 85 mmHg
  • Fasting glucose: > 100 mg·dl-1
  • Fasting triglycerides: > 150 mg·dl-1
  • HDL: men ≤ 40, women ≤ 50 mg·dl-1

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

Treatment and study plan

Haskap berry smoothie

Dietary Supplement

A smoothie blend of berries and water

Placebo Comparator

Dietary Supplement

A smoothie with no polyphenolic content and matched in carbohydrate composition to the experimental haskap smoothie

Primary outcomes

  1. 16 subunit ribosomal ribonucleic acid (16S rRNA) gut microbial composition

    Time frame: 8 weeks

    fecal microbial composition

  2. Inflammation (pg/mL)

    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)

  3. Lipid Panel (mg/dL)

    Time frame: 8 weeks

    Serum triglycerides (TG), low-density lipoprotein (LDL) cholesterol, high-density lipoprotein (HDL) cholesterol, total cholesterol (CHOL), glucose (GLU)

  4. F2 isoprostanes

    Time frame: 8 weeks

    urine

  5. Untargeted metabolomic analysis

    Time frame: 8 weeks

    Serum metabolome

  6. Untargeted metabolomic analysis

    Time frame: 8 weeks

    Fecal metabolome

  7. Exercise Induced Fat Oxidation

    Time frame: 8 weeks

    Measurement in g/min of fat being utilized during exercise at 40-60% of the participants estimated VO2max

Secondary outcomes

  1. Acute Diet

    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.

  2. Habitual Diet

    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.

  3. Anthropometric Assessments

    Time frame: 8 weeks

    waist circumference (cm)

  4. Anthropometric Assessments

    Time frame: 8 weeks

    visceral adipose (L)

  5. Anthropometric Assessments

    Time frame: 8 weeks

    BMI (kg/m2)

  6. Anthropometric Assessments

    Time frame: 8 weeks

    fat free mass (%)

  7. Blood pressure

    Time frame: 8 weeks

    SBP/DBP (mmHG)

  8. Estimated VO2 max

    Time frame: 0 weeks

    Estimation of participants VO2 max (ml/k/min) from a Fatmax test

Study contacts

Contact information is provided by the study sponsor or research team.

Mary P Miles, PhD

CONTACT

[email protected]

406-994-6678

Zachary T Miller, PhD

CONTACT

[email protected]

(406) 961-3025

Sponsors and collaborators

Lead sponsor

Montana State University

Other

Collaborators

  • Montana State Agricultural Experiment Station

Registry information

Official study title

PARTNERSHIP: Elucidating Gut Microbiota-dependent Health Impacts of Haskap Berries to Inform Agricultural Production Practices That Will Maximize Bioactive Potential

Acronym: HIH

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Aug 9, 2024
Registry last updated
Apr 2, 2025

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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