Postprandial HyperglycemiaGLU-FRUNCT02340039
Effects of Fruit Extracts on Glycaemia: The GLU-FRU Study
A study testing Polyphenols in people with Postprandial Hyperglycemia, run by King's College London at 1 site in United Kingdom.
Trial summary
Raised blood glucose levels can lead to adverse modifications to functional proteins within the body and eventually lead to the development of type 2 diabetes. Fruit polyphenols may help to control glycaemia following a carbohydrate meal or beverage. Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Postprandial Hyperglycemia
- What is being tested?
- Polyphenols
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2015to Jul 2015
- 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 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age: 20-60 y
- Male and female (post-menopausal only)
- Healthy (free of diagnosed diseases in the exclusion criteria)
- BMI 18-35 kg/m2
- Able to understand the information sheet and willing to comply with study protocol
- Able to give informed written consent
Who cannot join
- Those diagnosed with Phenylketonuria (PKU),
- Those with known or suspected food intolerances, allergies or hypersensitivity
- Women who are known to be pregnant or who are intending to become pregnant over the course of the study
- Women who are breast feeding
- Participation in another clinical trial
- Those who have donated blood within 3 months of the screening visit and participants for whom participation in this study would result in having donated more than 1500 millilitres of blood in the previous 12 months.
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- Those with Full Blood Counts and Liver Function test results outside of the normal range (see table 1 below).
- Pre-menopausal women due to the potential influence of cyclical changes in reproductive hormones on insulin sensitivity
- Current smokers, or reported giving up smoking within the last 6 months
- History of substance abuse or alcoholism
- Reported history of CVD, diabetes (or fasting glucose ≥ 7.1 mmol/L), cancer, kidney, liver or bowel disease, gastrointestinal disorder or use of drug likely to alter gastrointestinal function
- Unwilling to restrict consumption of specified high polyphenol foods for 24 h before the study
- Weight loss >3kg in preceding 2 months and body mass index <18 or >35 kg/m2
- Blood pressure ≥160/100 mmHg
- Total cholesterol ≥ 7.5 mmol/L; fasting triacylglycerol concentrations ≥ 5.0 mmol/L
- Medications that may interfere with the study such as alpha-glucosidase inhibitors (acarbose: Glucobay), insulin-sensitising drugs (metformin: Glucophage, Glucophage SR, Eucreas, Janumet; thiazolidinediones: Actos, Competact), sulfonylureas (Daonil, Diamicron MR, Glibenese, Minodiab, Amaryl Tolbutamide), and lipid-lowering drugs (statins, nicotinic acid, colestyramine anhydrous, ezetimibe, fibrates). Other medications should be reviewed by medical representative from KCL on a case by case basis.
- Nutritional supplements that may interfere with the study such as higher dose vitamins/minerals (>200% RNI), B vitamins, Vitamin C, calcium, copper, chromium, iodine, iron, magnesium, manganese, phosphorus, potassium and zinc. Subjects already taking vitamin or minerals at a dose around 100% or less up to 200% of the RNI, or evening primrose/algal/fish oil supplements will be asked to maintain habitual intake patterns, ensuring that they take them every day and not sporadically. They will be advised not to stop taking supplements or start taking new supplements during the course of the study.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Metabolic Research Unit at King's College London. Franklin-Wilkins Buiding. Waterloo Campus
London, England, W3 7LR
About this study
Official title: The Acute Effects of Blackcurrant and Apple Extracts on Postprandial Glycaemia: a Randomised Controlled Trial. The GLU-FRU Study
Raised blood glucose levels can lead to adverse modifications to functional proteins within the body and eventually lead to the development of type 2 diabetes. Fruit polyphenols may help to control glycaemia following a carbohydrate meal or beverage. The aim of this study is to investigate the effects of blackcurrant (BC) and apple (A) extracts on postprandial glycaemia, insulinaemia and plasma gastric inhibitory polypeptide concentrations following a mixed carbohydrate test meal.
Read the detailed description
Introduction:
Diets with a high glycaemic load (a measure of the overall blood glucose-raising effect of a serving of a food) and containing high amounts of non-milk extrinsic sugars may contribute towards increased risk of developing type 2 diabetes (T2D). Raised blood glucose levels can lead to adverse modifications to functional proteins within the body and eventually lead to the development of T2D. Large peaks in blood glucose after a meal are a risk factor for T2D, and therefore it is desirable to consume a diet that will allow more gradual rises in blood glucose levels after meals. Fruit polyphenols may help to control glycaemia following a carbohydrate meal or beverage. Possible mechanisms include inhibition of intestinal enzymes and inhibition of intestinal glucose absorption by decreasing SGLT1/GLUT2 transport activity. The scientific literature also suggests that foods rich in polyphenols exert beneficial effects on risk factors of cardiovascular disease such as hypertension, lipid metabolism and vascular function.
Study Design:
A randomised, controlled, double-blind, cross-over study will be conducted. Subjects will receive combined blackcurrant and apple polyphenols, apple polyphenols only or placebo in random order at 3 separate study visits immediately before a high-carbohydrate meal. Seven days wash-out period will be required between study days.Standardised diet and exercise advice will be given prior to the visit. Subjects will arrive on each study visit between 09.00 and 10.00 h, after a 12 h overnight fast. They will then be cannulated in a forearm vein and baseline fasting blood samples will be taken in duplicate. All test drinks will be blended to be equal in volume, macronutrient and energy content. Fruit extracts instead of whole fruits will be administered to avoid the confounding effect of fruit fibre/viscosity on gastric emptying rate. Following consumption of the test drink, the high carbohydrate meal (starch and sucrose) will be served (white bread with apricot jam). Outcome variables will be measured postprandially until 120 min post-meal.
- Conditions
- Postprandial Hyperglycemia
- Being tested
- Polyphenols
- Keywords
- Polyphenol, Fruit, Metabolic
- Medical subject headings
- Hyperglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PolyphenolsDietary supplement
Drinks will be delivered in random order at 3 separate study visits immediately before a high-carbohydrate meal. Seven days wash-out period will be required between study days.
| Study group | Role | What they receive |
|---|---|---|
| Blackcurrant &Apple | Experimental | 600 mg blackcurrant anthocyanins + 600 mg apple polyphenols delivered in a low sugar fruit drink Receives: Dietary Supplement: Polyphenols |
| Apple | Experimental | 1200 mg apple polyphenols delivered in a low sugar fruit drink Receives: Dietary Supplement: Polyphenols |
| Control drink | Placebo comparator | No polyphenols delivered in a low sugar fruit drink Receives: Dietary Supplement: Polyphenols |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postprandial glycaemia
Peak postprandial plasma glucose concentrations (Cmax) t +0-30 min and change from baseline data and areas over baseline t+0-30 min and t+0-120 min
Measured: baseline and 10, 20, 30, 45, 60, 75, 90 and 120 min following the test drink.
Secondary outcomes (7)
Postprandial insulinaemia
Peak postprandial insulin concentrations (Cmax) t +0-30 min and change from baseline data and areas over baseline t+0-30 min and t+0-120 min
Measured: baseline and 10, 20, 30, 45, 60, 75, 90 and 120 min following the test drink.
Postprandial glucose-dependent insulinotropic polypeptide (GIP) concentrations
Peak postprandial GIP concentrations (Cmax) t +0-30 min and change from baseline data and areas over baseline t+0-30 min and t+0-120 min
Measured: baseline and 10, 20, 30, 45, 60, 75, 90 and 120 min following the test drink.
Postprandial glucagon-like peptide-1 (GLP-1) concentrations
Peak postprandial GLP-1 concentrations (Cmax) t +0-30 min and change from baseline data and areas over baseline t+0-30 min and t+0-120 min
Measured: baseline and 10, 20, 30, 45, 60, 75, 90 and 120 min following the test drink.
Blood pressure
Change in the blood pressure after consumption of test drink
Measured: baseline and 60, 90 and 120 min following the test drink.
Vascular function (Digital Volume Pulse; DVP)
Change in the tone of larger arteries (stiffness index) and small to medium-sized arteries (reflection index).
Measured: baseline and 60, 90 and 120 min following the test drink.
Plasma non-esterified fatty acids (NEFA)
Peak postprandial NEFA concentrations (Cmax) t +0-30 min and change from baseline data and areas over baseline t+0-30 min and t+0-120 min
Measured: baseline and 10, 20, 30, 45, 60, 75, 90 and 120 min following the test drink.
Plasma triglycerides (TAG)
Peak postprandial TAG concentrations (Cmax) t +0-30 min and change from baseline data and areas over baseline t+0-30 min and t+0-120 min
Measured: baseline and 10, 20, 30, 45, 60, 75, 90 and 120 min following the test drink.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2015 (estimated)
- Study startJan 2015
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postprandial HyperglycemiaStudies of the same condition, open and under way.
- More trials run by King's College LondonThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Wendy Hall, King's College London
- Investigators
- Wendy L Hall, Dr, Principal investigator, King's College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02340039
- Sponsor's protocol ID
- GF2015
- Acronym
- GLU-FRU
- Status last verified
- Sep 2019
- First submitted
- 13 Jan 2015
- Last updated
- 16 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Acute Effects of Blackcurrant and Apple Extracts on Postprandial Glycaemia: a Randomised Controlled Trial. The GLU-FRU Study
- ClinicalTrials.gov ID
- NCT02340039
- Acronym / sponsor ID
- GLU-FRU / GF2015
- Conditions
- Postprandial Hyperglycemia
- Keywords
- Polyphenol, Fruit, Metabolic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 16 Jan 2015 (estimated)
- 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.
Raised blood glucose levels can lead to adverse modifications to functional proteins within the body and eventually lead to the development of type 2 diabetes. Fruit polyphenols may help to control glycaemia following a carbohydrate meal or beverage. The aim of this study is to investigate the effects of blackcurrant (BC) and apple (A) extracts on postprandial glycaemia, insulinaemia and plasma gastric inhibitory polypeptide concentrations following a mixed carbohydrate test meal.
Detailed description
Introduction:
Diets with a high glycaemic load (a measure of the overall blood glucose-raising effect of a serving of a food) and containing high amounts of non-milk extrinsic sugars may contribute towards increased risk of developing type 2 diabetes (T2D). Raised blood glucose levels can lead to adverse modifications to functional proteins within the body and eventually lead to the development of T2D. Large peaks in blood glucose after a meal are a risk factor for T2D, and therefore it is desirable to consume a diet that will allow more gradual rises in blood glucose levels after meals. Fruit polyphenols may help to control glycaemia following a carbohydrate meal or beverage. Possible mechanisms include inhibition of intestinal enzymes and inhibition of intestinal glucose absorption by decreasing SGLT1/GLUT2 transport activity. The scientific literature also suggests that foods rich in polyphenols exert beneficial effects on risk factors of cardiovascular disease such as hypertension, lipid metabolism and vascular function.
Study Design:
A randomised, controlled, double-blind, cross-over study will be conducted. Subjects will receive combined blackcurrant and apple polyphenols, apple polyphenols only or placebo in random order at 3 separate study visits immediately before a high-carbohydrate meal. Seven days wash-out period will be required between study days.Standardised diet and exercise advice will be given prior to the visit. Subjects will arrive on each study visit between 09.00 and 10.00 h, after a 12 h overnight fast. They will then be cannulated in a forearm vein and baseline fasting blood samples will be taken in duplicate. All test drinks will be blended to be equal in volume, macronutrient and energy content. Fruit extracts instead of whole fruits will be administered to avoid the confounding effect of fruit fibre/viscosity on gastric emptying rate. Following consumption of the test drink, the high carbohydrate meal (starch and sucrose) will be served (white bread with apricot jam). Outcome variables will be measured postprandially until 120 min post-meal.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Blackcurrant &Apple | Experimental | Dietary Supplement: Polyphenols600 mg blackcurrant anthocyanins + 600 mg apple polyphenols delivered in a low sugar fruit drink |
| Apple | Experimental | Dietary Supplement: Polyphenols1200 mg apple polyphenols delivered in a low sugar fruit drink |
| Control drink | Placebo comparator | Dietary Supplement: PolyphenolsNo polyphenols delivered in a low sugar fruit drink |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Age: 20-60 y
- Male and female (post-menopausal only)
- Healthy (free of diagnosed diseases in the exclusion criteria)
- BMI 18-35 kg/m2
- Able to understand the information sheet and willing to comply with study protocol
Key exclusion criteria (17 listed)
- Those diagnosed with Phenylketonuria (PKU),
- Those with known or suspected food intolerances, allergies or hypersensitivity
- Women who are known to be pregnant or who are intending to become pregnant over the course of the study
- Women who are breast feeding
- Participation in another clinical trial
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 |
|---|---|---|
| PolyphenolsDrinks will be delivered in random order at 3 separate study visits immediately before a high-carbohydrate meal. Seven days wash-out period will be required between study days. | Dietary supplement | Apple, Blackcurrant &Apple, Control drink |
Primary outcome
Postprandial glycaemia
Time frame: baseline and 10, 20, 30, 45, 60, 75, 90 and 120 min following the test drink.
Peak postprandial plasma glucose concentrations (Cmax) t +0-30 min and change from baseline data and areas over baseline t+0-30 min and t+0-120 min
7 secondary outcomes
Postprandial insulinaemia
Time frame: baseline and 10, 20, 30, 45, 60, 75, 90 and 120 min following the test drink.
Postprandial glucose-dependent insulinotropic polypeptide (GIP) concentrations
Time frame: baseline and 10, 20, 30, 45, 60, 75, 90 and 120 min following the test drink.
Postprandial glucagon-like peptide-1 (GLP-1) concentrations
Time frame: baseline and 10, 20, 30, 45, 60, 75, 90 and 120 min following the test drink.
Blood pressure
Time frame: baseline and 60, 90 and 120 min following the test drink.
Vascular function (Digital Volume Pulse; DVP)
Time frame: baseline and 60, 90 and 120 min following the test drink.
Plasma non-esterified fatty acids (NEFA)
Time frame: baseline and 10, 20, 30, 45, 60, 75, 90 and 120 min following the test drink.
Plasma triglycerides (TAG)
Time frame: baseline and 10, 20, 30, 45, 60, 75, 90 and 120 min following the test drink.
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 16 Sep 2019.
- Related InfoLink provided by the sponsor.
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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.
Wendy L Hall, Dr principal investigator
King's College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Polyphenols in people with Postprandial Hyperglycemia, run by King's College London 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 6 inclusion and 17 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 16 Sep 2019. 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. Some participants in this study may receive a placebo. 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?
Postprandial glycaemia (time frame: baseline and 10, 20, 30, 45, 60, 75, 90 and 120 min following the test drink.). 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 16 Sep 2019.