Prevention of HyperglycaemiaGLU-PommeNCT02940249
Effects of an Apple Extract on Glycaemia: The GLU-Pomme Study
A study testing Apple polyphenols in people with Prevention of Hyperglycaemia, run by King's College London at 1 site in United Kingdom.
Trial summary
Postprandial hyperglycaemia can lead to adverse modifications to functional proteins within the body and eventually lead to the development of type 2 diabetes. Previous research by this group has shown that an apple polyphenol extract reduced hyperglycaemia following a high-carbohydrate meal. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Prevention of Hyperglycaemia
- What is being tested?
- Apple 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 2017to Feb 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age: 18-70 y
- Male and female
- Healthy (free of diagnosed diseases listed in the exclusion criteria)
- Body Mass Index 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 and/or paracetamol 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.
Show all 16Show fewer
- Full Blood Counts and Liver Function test results outside of the normal range.
- Current smokers, or reported giving up smoking within the last 6 months
- History of substance abuse or alcoholism
- Reported history of Cardiovascular disease, 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 48 h before the study
- Weight change >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: alpha-glucosidase inhibitors (acarbose: Glucobay), insulin sensitizing drugs (metformin: Glucophage, Glucophage SR, Eucreas, Janumet; thiazolidinediones: Actos, Competact), sulfonylureas (Daonil, Diamicron, Diamicron MR, Glibenese, Minodiab, Amaryl Tolbutamide), and lipid lowering drugs (statins, nicotinic acid, colestyramine anhydrous, ezetimibe, fibrates); and medications that may react unpredictably with paracetamol: ketoconazole, metoclopramide, carbamazepine, phenobarbital, phenytoin, primidone, warfarin and other products containing paracetamol. Other medications should be reviewed by medical representative from KCL on a case by case basis.
- Nutritional supplements that may interfere with the study: higher dose vitamins/minerals (>200% Recommend Nutrient Intake), 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
Waterloo Campus, London, SE1 9NH
About this study
Official title: Dose-response Effect of an Apple Extract on Postprandial Glycaemia: a Randomised Controlled Trial. The GLU-POMME Study.
Postprandial hyperglycaemia can lead to adverse modifications to functional proteins within the body and eventually lead to the development of type 2 diabetes. Previous research by this group has shown that an apple polyphenol extract reduced hyperglycaemia following a high-carbohydrate meal. The aim of this study is to investigate the effects of lower doses of the apple extract on postprandial glycaemia, insulinaemia and plasma gastric inhibitory polypeptide concentrations following a mixed carbohydrate test meal.
Read the detailed description
Introduction:
Sharp peaks in blood glucose levels can lead to adverse modifications to functional proteins, oxidative stress and pancreatic beta cell dysfunction. It is therefore desirable to consume a diet that will allow more gradual rises in blood glucose levels after meals. Fruit polyphenols may help to limit the glucose excursion following a high carbohydrate meal. Previous research by this research group has demonstrated that 1200 mg of apple polyphenols (Appl'In™) inhibited the average incremental area under the curve (T+0 to T+30 min) of plasma glucose by 54% relative to placebo. Possible mechanisms include inhibition of intestinal enzymes and inhibition of intestinal glucose absorption by decreasing SGLT1/GLUT2 transport activity. The 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. Four matched test drinks will be consumed in random order on separate study visits immediately before a mixed-carbohydrate test meal, containing either: 1) 1.2 g, 2) 0.9 g 3). 0.6 g of apple polyphenols, or 4). placebo. Postprandial changes in plasma glucose, insulin, NEFA, GIP, GLP-1 concentrations as well as changes in vascular function will be measured. Twenty-four hour urine samples will be collected for analysis of urinary polyphenol metabolites and glucose. In a sub sample of participants, a paracetamol absorption test will be incorporated via addition of 1.5 g paracetamol into the test drink.
- Conditions
- Prevention of Hyperglycaemia
- Being tested
- Apple polyphenols, Placebo
- Keywords
- Polyphenol, Apple, Fruit, Hyperglycaemia, Metabolic
- Medical subject headings
- Hyperglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Apple polyphenolsDietary supplement
Drinks will be delivered in random order at 4 separate study visits immediately before a high-carbohydrate meal. Seven days wash-out period will be required between study days.
PlaceboDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| 1.2 g apple polyphenols | Experimental | 1200 mg apple polyphenols delivered in a low sugar drink. Receives: Dietary Supplement: Apple polyphenols |
| 0.9 g apple polyphenols | Experimental | 900 mg apple polyphenols delivered in a low sugar drink. Receives: Dietary Supplement: Apple polyphenols |
| 0.6 g apple polyphenols | Experimental | 600 mg apple polyphenols delivered in a low sugar drink. Receives: Dietary Supplement: Apple polyphenols |
| Placebo | Placebo comparator | No polyphenols delivered in a low sugar drink. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postprandial Glycaemia
Primary outcome: Area over baseline t+0-30 min for plasma glucose
Measured: 30 min following the test drink
Secondary outcomes (13)
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+0-240 min.
Measured: baseline and 10, 20, 30, 45, 60, 75, 90, 120, 150, 180, 240 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+0-240 min.
Measured: baseline and 10, 20, 30, 45, 60, 75, 90, 120, 150, 180, 240 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+0-240 min.
Measured: baseline and 10, 20, 30, 45, 60, 75, 90, 120, 150, 180, 240 min following the test drink
Postprandial C-peptide Concentrations
Peak postprandial C-peptide concentrations (Cmax) t +0-30 min and change from baseline data and areas over baseline t+0-30 min and t+0-240 min.
Measured: baseline and 10, 20, 30, 45, 60, 75, 90, 120, 150, 180, 240 min following the test drink
Postprandial Non-esterified Fatty Acid (NEFA) Concentrations
Peak postprandial NEFA concentrations (Cmax) t +0-30 min and change from baseline data and areas over baseline t+0-30 min and t+0-240 min
Measured: baseline and 10, 20, 30, 45, 60, 75, 90, 120, 150, 180, 240 min following the test drink
Postprandial Triglyceride (TAG) Concentrations
Peak postprandial TAG concentrations (Cmax) t +0-30 min and change from baseline data and areas over baseline t+0-30 min and t+0-240 min.
Measured: baseline and 10, 20, 30, 45, 60, 75, 90, 120, 150, 180, 240 min following the test drink
Postprandial Paracetamol Concentrations
Peak postprandial paracetamol concentrations (Cmax) t +0-30 min and change from baseline data and areas over baseline t+0-30 min and t+0-240 min (1.5 g paracetamol will be added to all test drinks in a sub-group of participants).
Measured: baseline and 10, 20, 30, 45, 60, 75, 90, 120, 150, 180, 240 min following the test drink
Postprandial Polyphenol Metabolite Concentrations
Peak postprandial polyphenol metabolites concentrations (Cmax) t +0-30 min and change from baseline data and areas over baseline t+0-30 min and t+0-240 min.
Measured: baseline and 10, 20, 30, 45, 60, 75, 90, 120, 150, 180, 240 min following the test drink
Vascular Endothelial Function by Flow-mediated Dilation (FMD)
Change in FMD after the consumption of test drink.
Measured: baseline and 120, 240, 300 min following the test drink
Vascular Function (Arteriograph Measurement)
Change in augmentation index following the test drink.
Measured: Baseline and 60, 90, 120, 180, 240 min following the test drink
Blood Pressure
Change in blood pressure following the test drink.
Measured: Baseline and 60, 90, 120, 180, 240 min following the test drink
Urinary Polyphenol Metabolites
Change in urinary polyphenol metabolite concentration following the test drink.
Measured: 0-4 h, 4-8 h, 8-24 h following the test drink
Urinary Glucose
Change in urinary glucose concentration following the test drink.
Measured: 0-4 h, 4-8 h, 8-24 h 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 posted20 Oct 2016 (estimated)
- Study startJan 2017
- Primary completionNov 2017
- Study completionFeb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Prevention of HyperglycaemiaStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Collaborators
- DIANA Food
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02940249
- Sponsor's protocol ID
- GLU-Pomme
- Acronym
- GLU-Pomme
- Status last verified
- Mar 2018
- First submitted
- 19 Oct 2016
- Last updated
- 17 Jun 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dose-response Effect of an Apple Extract on Postprandial Glycaemia: a Randomised Controlled Trial. The GLU-POMME Study.
- ClinicalTrials.gov ID
- NCT02940249
- Acronym / sponsor ID
- GLU-Pomme / GLU-Pomme
- Conditions
- Prevention of Hyperglycaemia
- Keywords
- Polyphenol, Apple, Fruit, Hyperglycaemia, Metabolic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Collaborators
- DIANA Food
- Study start
- Jan 2017
- Primary completion
- Nov 2017 (actual)
- Study completion
- Feb 2018 (actual)
- First posted
- 20 Oct 2016 (estimated)
- Results
- Posted 17 Jun 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Postprandial hyperglycaemia can lead to adverse modifications to functional proteins within the body and eventually lead to the development of type 2 diabetes. Previous research by this group has shown that an apple polyphenol extract reduced hyperglycaemia following a high-carbohydrate meal. The aim of this study is to investigate the effects of lower doses of the apple extract on postprandial glycaemia, insulinaemia and plasma gastric inhibitory polypeptide concentrations following a mixed carbohydrate test meal.
Detailed description
Introduction:
Sharp peaks in blood glucose levels can lead to adverse modifications to functional proteins, oxidative stress and pancreatic beta cell dysfunction. It is therefore desirable to consume a diet that will allow more gradual rises in blood glucose levels after meals. Fruit polyphenols may help to limit the glucose excursion following a high carbohydrate meal. Previous research by this research group has demonstrated that 1200 mg of apple polyphenols (Appl'In™) inhibited the average incremental area under the curve (T+0 to T+30 min) of plasma glucose by 54% relative to placebo. Possible mechanisms include inhibition of intestinal enzymes and inhibition of intestinal glucose absorption by decreasing SGLT1/GLUT2 transport activity. The 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. Four matched test drinks will be consumed in random order on separate study visits immediately before a mixed-carbohydrate test meal, containing either: 1) 1.2 g, 2) 0.9 g 3). 0.6 g of apple polyphenols, or 4). placebo. Postprandial changes in plasma glucose, insulin, NEFA, GIP, GLP-1 concentrations as well as changes in vascular function will be measured. Twenty-four hour urine samples will be collected for analysis of urinary polyphenol metabolites and glucose. In a sub sample of participants, a paracetamol absorption test will be incorporated via addition of 1.5 g paracetamol into the test drink.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1.2 g apple polyphenols | Experimental | Dietary Supplement: Apple polyphenols1200 mg apple polyphenols delivered in a low sugar drink. |
| 0.9 g apple polyphenols | Experimental | Dietary Supplement: Apple polyphenols900 mg apple polyphenols delivered in a low sugar drink. |
| 0.6 g apple polyphenols | Experimental | Dietary Supplement: Apple polyphenols600 mg apple polyphenols delivered in a low sugar drink. |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboNo polyphenols delivered in a low sugar drink. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age: 18-70 y
- Male and female
- Healthy (free of diagnosed diseases listed in the exclusion criteria)
- Body Mass Index 18-35 kg/m2
- Able to understand the information sheet and willing to comply with study protocol
Key exclusion criteria (16 listed)
- Those diagnosed with Phenylketonuria (PKU)
- Those with known or suspected food and/or paracetamol 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 |
|---|---|---|
| Apple polyphenolsDrinks will be delivered in random order at 4 separate study visits immediately before a high-carbohydrate meal. Seven days wash-out period will be required between study days. | Dietary supplement | 0.6 g apple polyphenols, 0.9 g apple polyphenols, 1.2 g apple polyphenols |
| Placebo | Dietary supplement | Placebo |
Primary outcome
Postprandial Glycaemia
Time frame: 30 min following the test drink
Primary outcome: Area over baseline t+0-30 min for plasma glucose
13 secondary outcomes
Postprandial Insulinaemia
Time frame: baseline and 10, 20, 30, 45, 60, 75, 90, 120, 150, 180, 240 min following the test drink
Postprandial Glucose-dependent Insulinotropic Polypeptide (GIP) Concentrations
Time frame: baseline and 10, 20, 30, 45, 60, 75, 90, 120, 150, 180, 240 min following the test drink
Postprandial Glucagon-like Peptide-1 (GLP-1) Concentrations
Time frame: baseline and 10, 20, 30, 45, 60, 75, 90, 120, 150, 180, 240 min following the test drink
Postprandial C-peptide Concentrations
Time frame: baseline and 10, 20, 30, 45, 60, 75, 90, 120, 150, 180, 240 min following the test drink
Postprandial Non-esterified Fatty Acid (NEFA) Concentrations
Time frame: baseline and 10, 20, 30, 45, 60, 75, 90, 120, 150, 180, 240 min following the test drink
Postprandial Triglyceride (TAG) Concentrations
Time frame: baseline and 10, 20, 30, 45, 60, 75, 90, 120, 150, 180, 240 min following the test drink
Postprandial Paracetamol Concentrations
Time frame: baseline and 10, 20, 30, 45, 60, 75, 90, 120, 150, 180, 240 min following the test drink
Postprandial Polyphenol Metabolite Concentrations
Time frame: baseline and 10, 20, 30, 45, 60, 75, 90, 120, 150, 180, 240 min following the test drink
Vascular Endothelial Function by Flow-mediated Dilation (FMD)
Time frame: baseline and 120, 240, 300 min following the test drink
Vascular Function (Arteriograph Measurement)
Time frame: Baseline and 60, 90, 120, 180, 240 min following the test drink
Blood Pressure
Time frame: Baseline and 60, 90, 120, 180, 240 min following the test drink
Urinary Polyphenol Metabolites
Time frame: 0-4 h, 4-8 h, 8-24 h following the test drink
Urinary Glucose
Time frame: 0-4 h, 4-8 h, 8-24 h following the test drink
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Apple polyphenols in people with Prevention of Hyperglycaemia, 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 16 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 17 Jun 2020. 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?
Yes. Results are posted in the registry (first posted 17 Jun 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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: 30 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 17 Jun 2020.