Haskap Berries and Gut Health Study

This study is looking at how Haskap berries affect your gut health and overall well-being. Researchers want to understand how the natural compounds in Haskap berries interact with the bacteria in your gut (gut microbiota) and if this leads to better health. You would either receive a Haskap berry smoothie or a placebo smoothie (a smoothie without the active berry ingredients but with similar carbohydrates). The study will measure changes in your gut bacteria, inflammation levels, and cholesterol (lipid panel) after 8 weeks. This study is for people aged 35 to 65, and includes both those who are generally metabolically healthy and those with some metabolic health concerns, such as specific waist circumference, blood pressure, or blood sugar levels.

Study design
This is a randomized, triple-blind, placebo-controlled study with 120 participants. Participants will be assigned to one of four groups, receiving either a Haskap berry smoothie or a placebo.
What's involved
Participants will be assessed before and after 8 weeks of intervention, which includes measurements of health biometrics, fat oxidation, gut microbiome composition, inflammation, and gut and serum metabolites.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoints are measured at 8 weeks, indicating the duration of the intervention period.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06546020

Gut Microbiota-dependent Health Impacts of Haskap Berries

Recruiting
NAAges 35–65InterventionalPrevention
Montana State University
~120 participants
Updated 2025-04-02 on ClinicalTrials.gov
What's tested:Haskap berry smoothiePlacebo comparator

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
16 subunit ribosomal ribonucleic acid (16S rRNA) gut microbial composition
Measured over 8 weeks
+6 more outcomes measured
Metabolic Disease
Inflammation
Microbial Colonization
1 sites across 1 states
Montana1
  • Mary P Miles, PhD · PRINCIPAL_INVESTIGATOR · Montana State University

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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
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

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
  • 16 subunit ribosomal ribonucleic acid (16S rRNA) gut microbial composition8 weeks

    fecal microbial composition

  • Inflammation (pg/mL)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)

  • Lipid Panel (mg/dL)8 weeks

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

  • F2 isoprostanes8 weeks

    urine

  • Untargeted metabolomic analysis8 weeks

    Serum metabolome

  • Untargeted metabolomic analysis8 weeks

    Fecal metabolome

  • Exercise Induced Fat Oxidation8 weeks

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