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Metabolic DiseaseHIHNCT06546020

Gut Microbiota-dependent Health Impacts of Haskap Berries

A study testing Haskap berry smoothie in people with Metabolic Disease and Inflammation, run by Montana State University at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 35 to 65 yearsHealthy volunteers can take part
What is being tested?
Haskap berry smoothie
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
120 participants
Where
1 siteUnited States
Study dates
26 Feb 2025to May 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 35 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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
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  • HDL: men > 40, women > 50 mg·dl-1
  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Mary P Miles, PhD contact

406-994-6678

mmiles@montana.edu

Zachary T Miller, PhD contact

(406) 961-3025

zachariah.miller@montana.edu

United States1 site, 1 recruiting

  • Montana State University

    Bozeman, Montana, 59717

    Mary P Miles, PhD, 406-994-6678, mmiles@montana.edu

    Brian Bothner, PhD, 1-406-994-5270, bbothner@montana.edu

    Recruiting

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
Haskap berry smoothie, Placebo comparator
Keywords
Microbial metabolism, Gut microbial composition, Serum metabolome, Polyphenols
Medical subject headings
Metabolic Diseases, Inflammation, Communicable Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Haskap berry smoothieDietary supplement

    A smoothie blend of berries and water

  • Placebo comparatorDietary supplement

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

Study groups in NCT06546020
Study groupRoleWhat they receive
Placebo, Metabolically HealthyPlacebo comparatorThe 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.
Receives: Dietary Supplement: Placebo comparator
Haskap, Metabolically HealthyExperimentalThe haskap supplement will consist of a haskap berry smoothie. A twice daily dose (10-12) hours apart will be consumed for 8 weeks.
Receives: Dietary Supplement: Haskap berry smoothie
Placebo, Metabolically UnhealthyPlacebo comparatorThe 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.
Receives: Dietary Supplement: Placebo comparator
Haskap, Metabolically UnhealthyExperimentalThe haskap supplement will consist of a haskap berry smoothie. A twice daily dose (10-12) hours apart will be consumed for 8 weeks.
Receives: Dietary Supplement: Haskap berry smoothie

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    fecal microbial composition

    Measured: 8 weeks

  2. 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)

    Measured: 8 weeks

  3. Lipid Panel (mg/dL)

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

    Measured: 8 weeks

  4. F2 isoprostanes

    urine

    Measured: 8 weeks

  5. Untargeted metabolomic analysis

    Serum metabolome

    Measured: 8 weeks

  6. Untargeted metabolomic analysis

    Fecal metabolome

    Measured: 8 weeks

  7. Exercise Induced Fat Oxidation

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

    Measured: 8 weeks

Secondary outcomes (8)

  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.

    Measured: 8 weeks

  2. 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.

    Measured: Baseline

  3. Anthropometric Assessments

    waist circumference (cm)

    Measured: 8 weeks

  4. Anthropometric Assessments

    visceral adipose (L)

    Measured: 8 weeks

  5. Anthropometric Assessments

    BMI (kg/m2)

    Measured: 8 weeks

  6. Anthropometric Assessments

    fat free mass (%)

    Measured: 8 weeks

  7. Blood pressure

    SBP/DBP (mmHG)

    Measured: 8 weeks

  8. Estimated VO2 max

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

    Measured: 0 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Aug 2024
  2. Study start26 Feb 2025
  3. Primary completionMay 2027 (estimated)
  4. Study completionMay 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06546020
Sponsor's protocol ID
2024-1417-FCR
Acronym
HIH
Status last verified
Apr 2025
First submitted
1 Aug 2024
Last updated
2 Apr 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Chamberlin ML, Spears ML, Cooper G, Miller ZJ, Bothner B, Walk ST, Yeoman CJ, Miles MP. Impact of the gut microbiome on health impacts of Haskap berries: study protocol for a randomized control trial. Trials. 2026 May 5;27(1):451. doi: 10.1186/s13063-026-09759-4.

    PubMed 42087172

Questions about this trial

What is this clinical trial studying?

A study testing Haskap berry smoothie in people with Metabolic Disease and Inflammation, run by Montana State University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 2 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Mary P Miles, PhD (406-994-6678, mmiles@montana.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

16 subunit ribosomal ribonucleic acid (16S rRNA) gut microbial composition (time frame: 8 weeks). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06546020, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2025.

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