Investigating the Effects of a Haskap Berry Supplement on Cognitive Health (HACVAC)

University of Reading

Status: Enrolling

Conditions: Cognition

Treatments: Dietary Supplement: Vitamin-and mineral-enhanced haskap berry powder; Dietary Supplement: Placebo; Dietary Supplement: Pure haskap berry powder

Study type: Interventional

Funder types: Other

Identifiers

NCT07119788

FA2_24-11 (Other Grant/Funding Number)

UREC 25/08

Details and patient eligibility

About

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+.

Full 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).

Enrollment: 90 estimated patients

Sex: All

Ages: 50+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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90 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: Placebo

Pure haskap berry powder

Experimental group

Description:

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

Treatment:

Dietary Supplement: Pure haskap berry powder

Vitamin- and mineral-enhanced haskap berry powder

Experimental group

Description:

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

Treatment:

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