The Scottish Fruit Study

NCT05513404 | Completed

• 1 other identifier: 2022_01/ROW-Honeyberry
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine if new varieties of fruits grown in Scotland which can adapt better to climate change namely, honeyberries and cherries, have the same health benefits as established fruits such as raspberries. To do this we will investigate the effects of consuming honeyberries, cherries, and raspberries on short term changes in blood glucose, and on short term memory.

Conditions

Postprandial Hypoglycemia; Age-Related Memory Disorders

Keywords

blood glucose; acute glycemic response; postprandial glycemia; short term memory; soft fruits; honeyberry; raspberry; cherry

Outcome Measures

Primary Outcomes (2)

• Change from baseline in postprandial glucose response associated with glycaemia in healthy normal/overweight men and post-menopausal women (40-70 years) when honeyberries, cherries or raspberries grown in Scotland are ingested.

  Based on our previous studies assuming a within-person spread of 10% (as observed previously), 16 volunteers are needed to detect a change in postprandial glucose response of 12% or more, with a power of 80% at the 5% significance level which is the primary outcome.

  4 hours

• Change from baseline in postprandial episodic memory in healthy normal/overweight men and post-menopausal women (40-70 years) when honeyberries, cherries or raspberries grown in Scotland are ingested.

  From a previous study on honeyberry and assuming a within-person variability for the episodic memory tests of 1.92, to detect a change in episodic memory of 15% requires 28 volunteers for 80% power.

  4 hours

Study Arms (4)

Breakfast only

NO INTERVENTION

This is an acute intervention study to compare the health benefits, in relation to changes in postprandial glucose and cognitive performance, of consumption of 3 soft fruits, raspberries, cherries, and honeyberries. It will have a randomised controlled crossover design where the volunteers will return for 4 stand-alone study sessions. All study procedures will be carried out at the Human Nutrition Unit (HNU) of the Rowett Institute. . The first study session will be an oral glucose tolerance test (OGTT). The glucose load for the OGTT in all sessions will be given as carbohydrate meal consisting of white bread, spread, low-polyphenol jam. (meal: 75g carbohydrate total). The remaining three will be intervention sessions which will be identical in all respects except for the addition of either honeyberry, cherry, or raspberry. There will be a minimum of 1 week washout period.

Honeyberry

EXPERIMENTAL

This arm will be an oral glucose tolerance test (OGTT). The glucose load for the OGTT in all sessions will be given as carbohydrate meal consisting of white bread, spread, low-polyphenol jam. (meal: 75g carbohydrate total) with the addition of honeyberry. There will be a minimum of 1 week washout period.

Dietary Supplement: Honeyberry

Cherry

EXPERIMENTAL

This arm will be an oral glucose tolerance test (OGTT). The glucose load for the OGTT in all sessions will be given as carbohydrate meal consisting of white bread, spread, low-polyphenol jam. (meal: 75g carbohydrate total) with the addition of cherrry. There will be a minimum of 1 week washout period.

Dietary Supplement: Cherry

Raspberry

EXPERIMENTAL

This arm will be an oral glucose tolerance test (OGTT). The glucose load for the OGTT in all sessions will be given as carbohydrate meal consisting of white bread, spread, low-polyphenol jam. (meal: 75g carbohydrate total) with the addition of raspberry. There will be a minimum of 1 week washout period.

Dietary Supplement: Raspberry

Interventions

Honeyberry DIETARY_SUPPLEMENT

To investigate changes in postprandial glucose and cognitive performance, after consumption of honeyberries grown in Scotland.

Honeyberry

Cherry DIETARY_SUPPLEMENT

To investigate changes in postprandial glucose and cognitive performance, after consumption of cherries grown in Scotland.

Cherry

Raspberry DIETARY_SUPPLEMENT

To investigate changes in postprandial glucose and cognitive performance, after consumption of raspberries grown in Scotland.

Raspberry

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy men or post-menopausal women
• Aged ≥40 and ≤ 70 years old.
• BMI ≥ 18.5 kg/m2
• HbA1c \<6.5%
• Neuropsychological screening tasks will include the Mini-Mental State Examination (MMSE), the National Adult Reading Test (NART), the Geriatric Depression Scale (GDS), the Trail Making Test (TMT), the Controlled Oral Word Association Test (COWAT), the Hopkins Verbal Learning Test (HVLT),
• MMSE \>= 27
• NART, TMT, COWAT and HVLT within acceptable norms

You may not qualify if:

• Those with any of the following will be excluded from participation:
• We will ask the volunteers to complete a questionnaire to state current health complaints and current medication use.
• Chronic illness, including: thromboembolic or coagulation disease unregulated thyroid disease kidney disease hepatic disease severe gastrointestinal disorders pulmonary disease (e.g. chronic bronchitis, COPD, pacemaker implant) Alcohol or any other substance abuse Eating disorders a history of neurological abnormalities, Women who are lactating or breastfeeding, pregnant Allergic/intolerant to foods provided in the study (Fruit allergy). Alcohol and/or other substance abuse Smoking and the use of e-cigarettes Physically active at a competitive level (exercising strenuously on a daily basis for long periods of time)
• MMSE \< 27
• GDS \> 5
• Self-report of prior diagnosis of dementia, probable dementia, or mild cognitive impairment
• History of stroke, severe head injury or other neurological condition which may adversely affect cognition
• history of anxiety and depression

Sponsors & Collaborators

• University of Aberdeen: lead

Study Sites (1)

Rowett Research Institute, University of Aberdeen

Aberdeen, AB24 2ZD, United Kingdom

Location

MeSH Terms

Conditions

Hypoglycemia; Memory Disorders

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Fiona M Campbell, PhD

  University of Aberdeen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This acute intervention study will have a randomised controlled crossover design where the volunteers will return for 4 stand-alone study sessions. All study procedures will be carried out at the Human Nutrition Unit (HNU) of the Rowett Institute.

Study Record Dates

• First Submitted: August 19, 2022
• First Posted: August 24, 2022
• Study Start: August 15, 2022
• Primary Completion: March 31, 2024
• Study Completion: March 31, 2024
• Last Updated: May 9, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)