Postprandial HypoglycemiaNCT05513404
The Scottish Fruit Study
A study testing Honeyberry, Cherry and Raspberry in people with Postprandial Hypoglycemia and Age-Related Memory Disorders, run by University of Aberdeen at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Postprandial Hypoglycemia, Age-Related Memory Disorders
- What is being tested?
- Honeyberry, Cherry and Raspberry
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 15 Aug 2022to 31 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
- Medication exclusion criteria Oral steroids Tricyclic antidepressants, neuroleptics Anticoagulants Digoxin and anti-arrhythmics Insulin, Sulphonylureas, Thiazolidinediones (glitazones), metformin. Chronic use of anti-inflammatories (e.g. > 200mgs doses of aspirin, ibuprofen), current psycho-active medication chlorphenamine
- Neuropsychological exclusion criteria
- MMSE < 27
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Rowett Research Institute, University of Aberdeen
Aberdeen, AB24 2ZD
About this study
Official title: Acute Study of Polyphenol-rich Honeyberries, Cherries, and Raspberries Grown in Scotland on Postprandial Glycaemic Response
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.
Read the detailed description
As humans spend most of their day in a postprandial state, it is imperative that the metabolic effects of diets are well understood if the incidence of chronic disorders such as type 2 diabetes (T2D) is to be controlled. Current estimates place global incidence of diabetes at 537 million, and this number is predicted to rise a further 45% by 2045. T2D is linked to increased risk of developing other chronic health conditions including cardiovascular disease (CVD) and dementia.
Controlling the acute glycaemic response and avoiding hyperglycaemia is essential for reducing diabetic risk. In addition, acute hyperglycaemia may provoke metabolic reactions increasing CVD risk and lower episodic memory even in non-diabetic individuals. Diet has an important role to play, and modern Western diets typically have high glycaemic loads due to excessive refined and total carbohydrate contents. As a result, the average blood glucose concentration of individuals has increased over the past three decades.
Polyphenolic constituents of foods may help to delay starch and disaccharide digestion and glucose absorption following a carbohydrate-containing meal or beverage. In vitro studies suggest that some polyphenols found in fruits are effective inhibitors of digestive enzymes, α-amylases and α-glucosidases and inhibit the action of intestinal glucose transporters. There is only a small amount of information available from human studies however, randomized controlled trials (RCTs) have shown that fruits reduced postprandial glucose concentrations following consumption of either starch, glucose or sucrose loads. Strategies to control chronic postprandial hyperglycaemia through increased consumption of such polyphenol rich foods would strengthen efforts to reduce the risk of developing T2D in the general population.
The aim of this study is to test the health benefits of new climate resistant fruit high in polyphenols grown in Scotland with and an existing crop already established in the fruit market. The hypothesis is that consumption of honeyberries and cherries grown in Scotland is as effective as raspberries in reducing the postprandial glycemic response in normal weight /overweight, healthy men, and post-menopausal women. With a secondary objective looking at the effects of these fruits on cognitive function.
This is a randomized cross over study and will aim to recruit 28 normal to overweight (BMI ≥ 18.5 and < 39.9), men or post-menopausal women (post-menopausal defined as not having had a period for over a year), aged ≥40 and ≤ 70 years who will attend four study sessions. The first study session will be an oral glucose tolerance test (OGTT) and the remaining three will be identical in all respects except for the addition of the fruit. Consecutive blood samples will be collected in all 4 study sessions which will be used to measure glucose, insulin, C-peptide, incretins, and lipids. Cognitive function the secondary outcome will be measured using a series of memory tests.
- Being tested
- Honeyberry, Cherry, Raspberry
- Keywords
- blood glucose, acute glycemic response, postprandial glycemia, short term memory, soft fruits, honeyberry, raspberry, cherry
- Medical subject headings
- Hypoglycemia, Memory Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HoneyberryDietary supplement
To investigate changes in postprandial glucose and cognitive performance, after consumption of honeyberries grown in Scotland.
CherryDietary supplement
To investigate changes in postprandial glucose and cognitive performance, after consumption of cherries grown in Scotland.
RaspberryDietary supplement
To investigate changes in postprandial glucose and cognitive performance, after consumption of raspberries grown in Scotland.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Dietary Supplement: Raspberry |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2022
- Study start15 Aug 2022
- Primary completion31 Mar 2024
- Study completion31 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postprandial HypoglycemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aberdeen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fiona M Campbell, PhD, Principal investigator, University of Aberdeen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05513404
- Sponsor's protocol ID
- 2022_01/ROW-Honeyberry
- Status last verified
- May 2024
- First submitted
- 19 Aug 2022
- Last updated
- 9 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Study of Polyphenol-rich Honeyberries, Cherries, and Raspberries Grown in Scotland on Postprandial Glycaemic Response
- ClinicalTrials.gov ID
- NCT05513404
- Acronym / sponsor ID
- 2022_01/ROW-Honeyberry
- Keywords
- blood glucose, acute glycemic response, postprandial glycemia, short term memory, soft fruits, honeyberry, raspberry, cherry
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of AberdeenUniversity, hospital or other
- Study start
- 15 Aug 2022 (actual)
- Primary completion
- 31 Mar 2024 (actual)
- Study completion
- 31 Mar 2024 (actual)
- First posted
- 24 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
As humans spend most of their day in a postprandial state, it is imperative that the metabolic effects of diets are well understood if the incidence of chronic disorders such as type 2 diabetes (T2D) is to be controlled. Current estimates place global incidence of diabetes at 537 million, and this number is predicted to rise a further 45% by 2045. T2D is linked to increased risk of developing other chronic health conditions including cardiovascular disease (CVD) and dementia.
Controlling the acute glycaemic response and avoiding hyperglycaemia is essential for reducing diabetic risk. In addition, acute hyperglycaemia may provoke metabolic reactions increasing CVD risk and lower episodic memory even in non-diabetic individuals. Diet has an important role to play, and modern Western diets typically have high glycaemic loads due to excessive refined and total carbohydrate contents. As a result, the average blood glucose concentration of individuals has increased over the past three decades.
Polyphenolic constituents of foods may help to delay starch and disaccharide digestion and glucose absorption following a carbohydrate-containing meal or beverage. In vitro studies suggest that some polyphenols found in fruits are effective inhibitors of digestive enzymes, α-amylases and α-glucosidases and inhibit the action of intestinal glucose transporters. There is only a small amount of information available from human studies however, randomized controlled trials (RCTs) have shown that fruits reduced postprandial glucose concentrations following consumption of either starch, glucose or sucrose loads. Strategies to control chronic postprandial hyperglycaemia through increased consumption of such polyphenol rich foods would strengthen efforts to reduce the risk of developing T2D in the general population.
The aim of this study is to test the health benefits of new climate resistant fruit high in polyphenols grown in Scotland with and an existing crop already established in the fruit market. The hypothesis is that consumption of honeyberries and cherries grown in Scotland is as effective as raspberries in reducing the postprandial glycemic response in normal weight /overweight, healthy men, and post-menopausal women. With a secondary objective looking at the effects of these fruits on cognitive function.
This is a randomized cross over study and will aim to recruit 28 normal to overweight (BMI ≥ 18.5 and < 39.9), men or post-menopausal women (post-menopausal defined as not having had a period for over a year), aged ≥40 and ≤ 70 years who will attend four study sessions. The first study session will be an oral glucose tolerance test (OGTT) and the remaining three will be identical in all respects except for the addition of the fruit. Consecutive blood samples will be collected in all 4 study sessions which will be used to measure glucose, insulin, C-peptide, incretins, and lipids. Cognitive function the secondary outcome will be measured using a series of memory tests.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| 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 | Dietary Supplement: HoneyberryThis 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. |
| Cherry | Experimental | Dietary Supplement: CherryThis 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. |
| Raspberry | Experimental | Dietary Supplement: RaspberryThis 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. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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),
Key exclusion criteria (10 listed)
- 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)
- Medication exclusion criteria Oral steroids Tricyclic antidepressants, neuroleptics Anticoagulants Digoxin and anti-arrhythmics Insulin, Sulphonylureas, Thiazolidinediones (glitazones), metformin. Chronic use of anti-inflammatories (e.g. > 200mgs doses of aspirin, ibuprofen), current psycho-active medication chlorphenamine
- Neuropsychological exclusion criteria
- MMSE < 27
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HoneyberryTo investigate changes in postprandial glucose and cognitive performance, after consumption of honeyberries grown in Scotland. | Dietary supplement | Honeyberry |
| CherryTo investigate changes in postprandial glucose and cognitive performance, after consumption of cherries grown in Scotland. | Dietary supplement | Cherry |
| RaspberryTo investigate changes in postprandial glucose and cognitive performance, after consumption of raspberries grown in Scotland. | Dietary supplement | Raspberry |
Primary outcome
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.
Time frame: 4 hours
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.
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.
Time frame: 4 hours
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fiona M Campbell, PhD principal investigator
University of Aberdeen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Honeyberry, Cherry and Raspberry in people with Postprandial Hypoglycemia and Age-Related Memory Disorders, run by University of Aberdeen at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 4 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2024.