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Recruiting NCT07119788

Investigating the Effects of a Haskap Berry Supplement on Cognitive Health

No phase Interventional Cognition

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Placebo, Pure haskap berry powder, Vitamin-and mineral-enhanced haskap berry powder.
Who it may be relevant to
Registry conditions: Cognition. Basic parameters: from 50 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United Kingdom
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Investigating the Cognitive, Vascular, and Metabolic Benefits of a Vitamin- and Mineral-Enhanced Haskap Berry Dietary Supplement

Overview

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+.

Detailed description

This project aims to investigate the acute benefits (during the immediate post prandial period up to 2 hours) and chronic benefits (following 4 weeks daily supplementation) of a vitamin- and mineral-enhanced haskap berry supplement made from freeze-dried, powdered haskap berries. The main objective of this study is to trial the product in older adults aged 50+ to determine any cognitive, metabolic, or cardiovascular benefits over and above haskap powder alone or a placebo powder. The study will involve a screening visit and two testing visits, 4 weeks apart. For the 24 hours prior to each test visit, participants are asked to follow a low polyphenol diet. They are requested not to consume any food or drinks except water after 8.30pm, and on the morning of test visits to only consume one slice of buttered white toast and a glass of water prior to attending the visit. During the testing visits, cognitive and mood battery tests (to include measures of memory, executive functions, and stress, will be taken at baseline, at 2 hours following the consumption of the supplement as part of a meal, and again at 4 weeks following daily consumption of the supplement added to their usual diet. Blood glucose finger pricks will be recorded at each time point along with FMD (a measure of vascular reactivity).

Interventions

  • Dietary supplement Placebo
    6g serving of a calorie-matched powder, artificially coloured and flavoured to resemble berry powder
  • Dietary supplement Pure haskap berry powder
    6g serving of a pure, freeze-dried haskap berry powder
  • Dietary supplement Vitamin-and mineral-enhanced haskap berry powder
    6g serving of a vitamin- and mineral-enhanced haskap berry powder (fortified with potassium iodide, zinc bisglycinate, vitamin B5, and vitamin B12

Primary outcome measures

  • Delayed recall (Rey Auditory Verbal Learning Task) [Time frame: Baseline]
  • Delayed recall (Rey Auditory Verbal Learning Task) [Time frame: 2 hours]
  • Delayed recall (Rey Auditory Verbal Learning Task) [Time frame: 4 weeks]
Secondary outcome measures (12)
  • Rate of learning (Rey Auditory Verbal Learning Task) [Time frame: Baseline]
  • Rate of learning (Rey Auditory Verbal Learning Task) [Time frame: 2 hours]
  • Rate of learning (Rey Auditory Verbal Learning Task) [Time frame: 4 weeks]
  • Word recognition (Rey Auditory Verbal Learning Task) [Time frame: Baseline]
  • Word recognition (Rey Auditory Verbal Learning Task) [Time frame: 2 hours]
  • Word recognition (Rey Auditory Verbal Learning Task) [Time frame: 4 weeks]
  • Modified Attention Network Task (MANT) [Time frame: Baseline]
  • Modified Attention Network Task (MANT) [Time frame: 2 hours]
  • Modified Attention Network Task (MANT) [Time frame: 4 weeks]
  • Task Switching Task [Time frame: Baseline]
  • Task Switching Task [Time frame: 2 hours]
  • Task Switching Task [Time frame: 4 weeks]

Eligibility criteria

Inclusion criteria

  • 50+ 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

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

United Kingdom · 1 center
  • Nutrition, Cognition & Health Lab, School of Psychology and Clinical Language Sciences, Un — Reading

Identifiers

NCT: NCT07119788 · UREC 25/08 · FA2_24-11

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗