NCT07119788

Brief Summary

This study aims to investigate the postprandial (2h) and longer term (4 week) effects of a haskap berry supplement on cognitive, vascular, and metabolic function in healthy ageing adults aged 50+.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2025

Shorter than P25 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 19, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 5, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 13, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2026

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2026

Completed
Last Updated

August 13, 2025

Status Verified

August 1, 2025

Enrollment Period

8 months

First QC Date

August 5, 2025

Last Update Submit

August 5, 2025

Conditions

Cognition

Keywords

CognitionMoodStressVascularBlood glucoseHaskap berries

Outcome Measures

Primary Outcomes (3)

  • Delayed recall (Rey Auditory Verbal Learning Task)

    The RAVLT is a verbal learning task that presents participants with 15 words (list A) 5 times, giving participants one minute after each presentation to recall as many words as they can from the list. After 5 presentations, a new list (list B) is presented and recalled, and finally participants are asked (without hearing list A again) to recall as many words as they can from list A. After a 30 minute period, participants are asked to think back to the task and recall as many words as possible from list A only, providing a measure of delayed recall.

    Baseline

  • Delayed recall (Rey Auditory Verbal Learning Task)

    The RAVLT is a verbal learning task that presents participants with 15 words (list A) 5 times, giving participants one minute after each presentation to recall as many words as they can from the list. After 5 presentations, a new list (list B) is presented and recalled, and finally participants are asked (without hearing list A again) to recall as many words as they can from list A. After a 30 minute period, participants are asked to think back to the task and recall as many words as possible from list A only, providing a measure of delayed recall.

    2 hours

  • Delayed recall (Rey Auditory Verbal Learning Task)

    The RAVLT is a verbal learning task that presents participants with 15 words (list A) 5 times, giving participants one minute after each presentation to recall as many words as they can from the list. After 5 presentations, a new list (list B) is presented and recalled, and finally participants are asked (without hearing list A again) to recall as many words as they can from list A. After a 30 minute period, participants are asked to think back to the task and recall as many words as possible from list A only, providing a measure of delayed recall.

    4 weeks

Secondary Outcomes (29)

  • Rate of learning (Rey Auditory Verbal Learning Task)

    Baseline

  • Rate of learning (Rey Auditory Verbal Learning Task)

    2 hours

  • Rate of learning (Rey Auditory Verbal Learning Task)

    4 weeks

  • Word recognition (Rey Auditory Verbal Learning Task)

    Baseline

  • Word recognition (Rey Auditory Verbal Learning Task)

    2 hours

  • +24 more secondary outcomes

Other Outcomes (2)

  • IQ (Raven's Progressive Matrices)

    Baseline

  • Habitual diet (Epic-Norfolk Food Frequency Questionnaire)

    Baseline

Study Arms (3)

Placebo

PLACEBO COMPARATOR

30 participants to receive daily 6g servings of a calorie-matched powder, artificially coloured and flavoured to resemble berry powder

Dietary Supplement: Placebo

Pure haskap berry powder

EXPERIMENTAL

30 participants to receive daily 6g servings of a pure, freeze-dried haskap berry powder

Dietary Supplement: Pure haskap berry powder

Vitamin- and mineral-enhanced haskap berry powder

EXPERIMENTAL

30 participants to receive daily 6g servings of a vitamin- and mineral-enhanced haskap berry powder (fortified with potassium iodide, zinc bisglycinate, vitamin B5, and vitamin B12

Dietary Supplement: Vitamin-and mineral-enhanced haskap berry powder

Interventions

PlaceboDIETARY_SUPPLEMENT

6g serving of a calorie-matched powder, artificially coloured and flavoured to resemble berry powder

Placebo
Pure haskap berry powderDIETARY_SUPPLEMENT

6g serving of a pure, freeze-dried haskap berry powder

Pure haskap berry powder
Vitamin-and mineral-enhanced haskap berry powderDIETARY_SUPPLEMENT

6g serving of a vitamin- and mineral-enhanced haskap berry powder (fortified with potassium iodide, zinc bisglycinate, vitamin B5, and vitamin B12

Vitamin- and mineral-enhanced haskap berry powder

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • + years old
  • Fruit \& veg intake less than or equal to 4 servings per day
  • Adequate English language and visual \& auditory acuity to perform the cognitive tasks
  • Normal BMI for age

You may not qualify if:

  • Being diagnosed with psychological or psychiatric disorders
  • ADHD or dyslexia
  • Any food allergy or intolerance
  • Use of medications and dietary supplements that may impact study results
  • Antibiotic use within the last 3 months
  • Adherence to vegan or vegetarian diets, or other specific diets that may impact study outcomes
  • Conditions altering absorption of nutrients (e.g. celiac disease)
  • Being diagnosed with cardiometabolic disease (including type II diabetes and cardiovascular disease), or suffer from untreated hypertension or thrombosis related disorders
  • Taking blood thinners

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nutrition, Cognition & Health Lab, School of Psychology and Clinical Language Sciences, University of Reading

Reading, RG6 6ES, United Kingdom

RECRUITING

Study Officials

  • Claire Williams

    University of Reading

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lynne Bell

CONTACT

01189788313l.bell@reading.ac.uk

Claire M Williams

CONTACT

0118 378 7540claire.williams@reading.ac.uk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants will be allocated to receive either a vitamin- and mineral-enhanced haskap berry powdered supplement, pure haskap berry powder, or a calorie matched placebo powder
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 5, 2025

First Posted

August 13, 2025

Study Start

June 19, 2025

Primary Completion

February 1, 2026

Study Completion

April 1, 2026

Last Updated

August 13, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will share

All relevant study outcomes described in the Ethics Review Application Form, including demographics, anthropometrics, cognitive performance, blood glucose, and FMD data, will be preserved and made available via a data repository, such as the University of Reading data repository, in anonymised form, so that they can be consulted and re-used by others.

Locations

GB(1)