NCT06546020

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
23mo left

Started Feb 2025

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress41%
Feb 2025May 2028

First Submitted

Initial submission to the registry

August 1, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 9, 2024

Completed
7 months until next milestone

Study Start

First participant enrolled

February 26, 2025

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2028

Last Updated

April 2, 2025

Status Verified

April 1, 2025

Enrollment Period

2.2 years

First QC Date

August 1, 2024

Last Update Submit

April 1, 2025

Conditions

Metabolic DiseaseInflammationMicrobial Colonization

Keywords

Microbial metabolismGut microbial compositionSerum metabolomePolyphenols

Outcome Measures

Primary Outcomes (7)

  • 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

  • Exercise Induced Fat Oxidation

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

    8 weeks

Secondary Outcomes (8)

  • Acute Diet

    8 weeks

  • Habitual Diet

    Baseline

  • Anthropometric Assessments

    8 weeks

  • Anthropometric Assessments

    8 weeks

  • Anthropometric Assessments

    8 weeks

  • +3 more secondary outcomes

Study Arms (4)

Placebo, Metabolically Healthy

PLACEBO COMPARATOR

The 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.

Dietary Supplement: Placebo comparator

Haskap, Metabolically Healthy

EXPERIMENTAL

The haskap supplement will consist of a haskap berry smoothie. A twice daily dose (10-12) hours apart will be consumed for 8 weeks.

Dietary Supplement: Haskap berry smoothie

Placebo, Metabolically Unhealthy

PLACEBO COMPARATOR

The 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.

Dietary Supplement: Placebo comparator

Haskap, Metabolically Unhealthy

EXPERIMENTAL

The haskap supplement will consist of a haskap berry smoothie. A twice daily dose (10-12) hours apart will be consumed for 8 weeks.

Dietary Supplement: Haskap berry smoothie

Interventions

Haskap berry smoothieDIETARY_SUPPLEMENT

A smoothie blend of berries and water

Haskap, Metabolically HealthyHaskap, Metabolically Unhealthy
Placebo comparatorDIETARY_SUPPLEMENT

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

Placebo, Metabolically HealthyPlacebo, Metabolically Unhealthy

Eligibility Criteria

Age35 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Montana State University

Bozeman, Montana, 59717, United States

RECRUITING

MeSH Terms

Conditions

Metabolic DiseasesInflammationCommunicable Diseases

Condition Hierarchy (Ancestors)

Nutritional and Metabolic DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsInfectionsDisease Attributes

Study Officials

  • Mary P Miles, PhD

    Montana State University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mary P Miles, PhD

CONTACT

406-994-6678mmiles@montana.edu

Zachary T Miller, PhD

CONTACT

(406) 961-3025zachariah.miller@montana.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
Placebo and haskap interventions were designed to be comparable in taste and appearance.
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 1, 2024

First Posted

August 9, 2024

Study Start

February 26, 2025

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

May 1, 2028

Last Updated

April 2, 2025

Record last verified: 2025-04

Locations

US(1)