Hyperglycemia, PostprandialPolyGlucHealNCT03255876
Effects of Enriched Fruit Juice on Blood Glucose Levels After a Meal in Healthy Subjects
A study testing Enriched pomegranate juice in people with Hyperglycemia, Postprandial and Healthy, run by University of Leeds at 1 site in United Kingdom.
Trial summary
Results from a large number of studies in humans have shown that diets rich in foods that give lower glucose response bring lower risk of type 2 diabetes. Polyphenols, naturally found in fruits, vegetables and grains, have shown the potential to attenuate post-prandial blood glucose spikes following a… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Hyperglycemia, Postprandial, Healthy
- What is being tested?
- Enriched pomegranate juice
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 10 Apr 2017to 1 Sep 2018
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Fasting glucose ≤ 5.6 mM;
- Body mass index (BMI) ≤ 30;
- Max glucose after the consumption of app. 109g of white bread less than about 8-9 mM (which is typical for the subjects we have measured previously);
Who cannot join
- Smoking;
- Participating in another trial that requires blood collection;
- Diagnosed with any chronic illness (including diabetes, hypertension etc.);
- On long term prescribed medication (except contraceptives);
- Pregnant or lactating;
- On a special diet or dietary regimen (for weight management or if regularly consuming fruit extract supplements);
- Allergy to fruits vegetables or pollen.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
School of Food Science and Nutrition, University of Leeds
Leeds, West Yorkshire, LS2 9JT
Gary Williamson, PhD, +441133438380, G.Williamson@leeds.ac.uk
Aleksandra Konic Ristic, PhD, +441133432979, a.konicristic@leeds.ac.uk
About this study
Results from a large number of studies in humans have shown that diets rich in foods that give lower glucose response bring lower risk of type 2 diabetes. Polyphenols, naturally found in fruits, vegetables and grains, have shown the potential to attenuate post-prandial blood glucose spikes following a carbohydrate-rich meal, through partial inhibition of the main enzymes of carbohydrate digestion and reduction in glucose and fructose transport from the gut after digestion and by enhancing the insulin action after glucose reaches the bloodstream.
This study is designed to determine whether polyphenols, as normally and naturally present in food extracts and beverages, added to a carbohydrate-rich meal, can lower blood glucose levels after its consumption, and hence lower its glycaemic index, and if this effect is mediated through effects on insulin and other hormones. The study is designed as an acute, double-blind, randomised, placebo-controlled crossover trial in 24 healthy subjects with normal glycaemic response to white bread. Participants will be asked to consume either white bread with pomegranate juice enriched with extracts from grape seeds and apple peels or white bread with placebo drink. The effects on plasma glucose levels, levels of hormones and other biomarkers involved in postprandial response will be determined over 3 hours after the consumption.
Read the detailed description
Consumption of carbohydrate-rich foods or sugary drinks affects blood glucose levels. Results from a large number of studies in humans have shown that diets rich in foods that give lower glucose response beneficially affect elevated fasting blood glucose and insulin levels, increase the sensitivity to insulin, contribute to the reduction of body weight and lipids levels and ultimately bring lower risk of type 2 diabetes.
Blood glucose responses depend on the amount and type of carbohydrate(s) present in the meal. Difference in post-prandial blood glucose response to different types of carbohydrates is mainly due to the different rate of their digestion. However, response to the same carbohydrate-rich food can be different between different individuals. Blood glucose levels after carbohydrate-rich meal are shown to be significantly higher in subjects on high-fat diet, in overweight or obese people, or in subjects with different levels of digestive enzymes.
Results from in vitro studies indicate the potential of polyphenols, naturally found in fruits, vegetables and grains, to attenuate post-prandial blood glucose spikes following a carbohydrate-rich meal. It was previously shown that different polyphenols can slow down carbohydrate digestion through partial inhibition of the main enzymes involved, can decrease glucose and fructose transport from the gut after digestion and can improve the action of insulin after glucose reaches the bloodstream.
In the previous study it was shown that pomegranate juice attenuates the increase in blood glucose levels after a starchy meal. This effect is, at least partly, the result of hindered starch digestion by polyphenols present in pomegranate juice.
The present study will determine whether polyphenols, as normally and naturally present in food extracts and beverages, added to a carbohydrate-rich meal, can lower blood glucose levels after its consumption, and hence lower its glycaemic index, and if this effect is mediated through effects on insulin and other hormones or determined by the individual levels of digestive enzymes.
Healthy volunteers will be asked to consume two different meals: (1) white bread with pomegranate juice enriched with extracts from grape seeds and apple peels or (2) white bread with placebo drink with the same type and amount of carbohydrates and similar flavor as enriched pomegranate juice, but without polyphenols.
The levels of glucose, insulin, gastric inhibitory polypeptide (GIP) and glucagon like peptide-1 (GLP-1) will be measured in plasma isolated from blood samples obtained before and up to 3 hours after the consumption of each meal. The levels of triglycerides and relevant organic and fatty acids will also be determined.
Before recruitment volunteers will be screened for eligibility based on glucose levels, BMI and glycemic response to white bread. Additional measurements taken at the screening will include blood pressure values and blood lipids levels. All participants will be characterized for the activity of salivary a-amylase and copies of a-amylase gene (AMY1).
- Conditions
- Hyperglycemia, Postprandial, Healthy
- Being tested
- Enriched pomegranate juice, Placebo beverage
- Keywords
- Polyphenols, Hyperglycemia, Postprandial, Starch, Alpha-amylase
- Medical subject headings
- Hyperglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enriched pomegranate juiceDietary supplement
Pure pomegranate juice enriched with grape seed and apple peel extract (200 ml) to be consumed with 109 g of bread
Placebo beverageDietary supplement
Beverage containing the same type and amount of carbohydrates as pomegranate juice and similar flavor (200 ml) to be consumed with 109 g of bread
| Study group | Role | What they receive |
|---|---|---|
| Enriched pomegranate juice | Experimental | Participants will consume 200 ml of pure pomegranate juice enriched with grape seed and apple peel extracts concomitantly with 109 g of white bread Receives: Dietary Supplement: Enriched pomegranate juice |
| Placebo beverage | Placebo comparator | Participants will consume 200 ml of placebo drink concomitantly with 109 g of white bread Receives: Dietary Supplement: Placebo beverage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in maximal incremental plasma glucose level (iCmax) between baseline and endpoint within the intervention group vs. placebo control.
The incremental glucose levels will be determined for each time point (at 15, 30, 45, 60, 90, 120, 150 and 180 min) as the change in plasma glucose levels after the consumption of enriched pomegranate juice or placebo drink concomitantly with white bread, compared to the glucose levels before the consumption of test meals (baseline value, t=0min).
Measured: Baseline, 15 min, 30 min, 45 min, 60 min, 90 min, 120 min, 150 min, 180 min.
Secondary outcomes (4)
Changes in area under the curve of incremental plasma glucose levels (iAUC) in the intervention group vs. placebo control.
The glucose iAUC will be determined from all incremental plasma glucose levels at the defined time points (0, 15, 30, 45, 60, 90, 120, 150 and 180 min) after the consumption of test and control meals based on trapezoid rule.
Measured: Baseline, 15 min, 30 min, 45 min, 60 min, 90 min, 120 min, 150 min, 180 min.
Changes in plasma insulin levels between baseline and endpoint within the intervention group vs. placebo control.
Insulin levels measured at the baseline and at each time point (at 15, 30, 45, 60, 90,120, 150 and 180 min) after the consumption of test and control meals.
Measured: Baseline, 15 min, 30 min, 45 min, 60 min, 90 min, 120 min, 150 min, 180 min.
Changes in plasma gastric inhibitory peptide (GIP) levels between baseline and endpoint within the intervention group vs. placebo control.
GIP levels measured in plasma at the baseline and at each time point (at 15, 30, 45, 60, 90,120, 150 and 180 min) after the consumption of test and control meals.
Measured: Baseline, 15 min, 30 min, 45 min, 60 min, 90 min, 120 min, 150 min, 180 min.
Changes in glucagon-like peptide-1 (GIP-1) levels between baseline and endpoint within the intervention group vs. placebo control.
GLP-1 levels measured in plasma at the baseline and at each time point (at 15, 30, 45, 60, 90,120, 150 and 180 min) after the consumption of test and control meals.
Measured: Baseline, 15 min, 30 min, 45 min, 60 min, 90 min, 120 min, 150 min, 180 min.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2017
- Study start10 Apr 2017
- Primary completion20 Aug 2018 (estimated)
- Study completion1 Sep 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hyperglycemia, PostprandialStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Leeds
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gary Williamson, University of Leeds
- Investigators
- Gary Williamson, PhD, Study chair, University of LeedsAleksandra Konic Ristic, PhD, Principal investigator, University of Leeds
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03255876
- Sponsor's protocol ID
- MEEC 16-011
- Acronym
- PolyGlucHeal
- Status last verified
- Jun 2018
- First submitted
- 17 Aug 2017
- Last updated
- 28 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Enriched Fruit Juice on Blood Glucose Levels After a Meal in Healthy Subjects
- ClinicalTrials.gov ID
- NCT03255876
- Acronym / sponsor ID
- PolyGlucHeal / MEEC 16-011
- Conditions
- Hyperglycemia, Postprandial, Healthy
- Keywords
- Polyphenols, Hyperglycemia, Postprandial, Starch, Alpha-amylase
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- University of LeedsUniversity, hospital or other
- Study start
- 10 Apr 2017 (actual)
- Primary completion
- 20 Aug 2018 (estimated)
- Study completion
- 1 Sep 2018 (estimated)
- First posted
- 21 Aug 2017 (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.
Results from a large number of studies in humans have shown that diets rich in foods that give lower glucose response bring lower risk of type 2 diabetes. Polyphenols, naturally found in fruits, vegetables and grains, have shown the potential to attenuate post-prandial blood glucose spikes following a carbohydrate-rich meal, through partial inhibition of the main enzymes of carbohydrate digestion and reduction in glucose and fructose transport from the gut after digestion and by enhancing the insulin action after glucose reaches the bloodstream.
This study is designed to determine whether polyphenols, as normally and naturally present in food extracts and beverages, added to a carbohydrate-rich meal, can lower blood glucose levels after its consumption, and hence lower its glycaemic index, and if this effect is mediated through effects on insulin and other hormones. The study is designed as an acute, double-blind, randomised, placebo-controlled crossover trial in 24 healthy subjects with normal glycaemic response to white bread. Participants will be asked to consume either white bread with pomegranate juice enriched with extracts from grape seeds and apple peels or white bread with placebo drink. The effects on plasma glucose levels, levels of hormones and other biomarkers involved in postprandial response will be determined over 3 hours after the consumption.
Detailed description
Consumption of carbohydrate-rich foods or sugary drinks affects blood glucose levels. Results from a large number of studies in humans have shown that diets rich in foods that give lower glucose response beneficially affect elevated fasting blood glucose and insulin levels, increase the sensitivity to insulin, contribute to the reduction of body weight and lipids levels and ultimately bring lower risk of type 2 diabetes.
Blood glucose responses depend on the amount and type of carbohydrate(s) present in the meal. Difference in post-prandial blood glucose response to different types of carbohydrates is mainly due to the different rate of their digestion. However, response to the same carbohydrate-rich food can be different between different individuals. Blood glucose levels after carbohydrate-rich meal are shown to be significantly higher in subjects on high-fat diet, in overweight or obese people, or in subjects with different levels of digestive enzymes.
Results from in vitro studies indicate the potential of polyphenols, naturally found in fruits, vegetables and grains, to attenuate post-prandial blood glucose spikes following a carbohydrate-rich meal. It was previously shown that different polyphenols can slow down carbohydrate digestion through partial inhibition of the main enzymes involved, can decrease glucose and fructose transport from the gut after digestion and can improve the action of insulin after glucose reaches the bloodstream.
In the previous study it was shown that pomegranate juice attenuates the increase in blood glucose levels after a starchy meal. This effect is, at least partly, the result of hindered starch digestion by polyphenols present in pomegranate juice.
The present study will determine whether polyphenols, as normally and naturally present in food extracts and beverages, added to a carbohydrate-rich meal, can lower blood glucose levels after its consumption, and hence lower its glycaemic index, and if this effect is mediated through effects on insulin and other hormones or determined by the individual levels of digestive enzymes.
Healthy volunteers will be asked to consume two different meals: (1) white bread with pomegranate juice enriched with extracts from grape seeds and apple peels or (2) white bread with placebo drink with the same type and amount of carbohydrates and similar flavor as enriched pomegranate juice, but without polyphenols.
The levels of glucose, insulin, gastric inhibitory polypeptide (GIP) and glucagon like peptide-1 (GLP-1) will be measured in plasma isolated from blood samples obtained before and up to 3 hours after the consumption of each meal. The levels of triglycerides and relevant organic and fatty acids will also be determined.
Before recruitment volunteers will be screened for eligibility based on glucose levels, BMI and glycemic response to white bread. Additional measurements taken at the screening will include blood pressure values and blood lipids levels. All participants will be characterized for the activity of salivary a-amylase and copies of a-amylase gene (AMY1).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Enriched pomegranate juice | Experimental | Dietary Supplement: Enriched pomegranate juiceParticipants will consume 200 ml of pure pomegranate juice enriched with grape seed and apple peel extracts concomitantly with 109 g of white bread |
| Placebo beverage | Placebo comparator | Dietary Supplement: Placebo beverageParticipants will consume 200 ml of placebo drink concomitantly with 109 g of white bread |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Fasting glucose ≤ 5.6 mM;
- Body mass index (BMI) ≤ 30;
- Max glucose after the consumption of app. 109g of white bread less than about 8-9 mM (which is typical for the subjects we have measured previously);
Key exclusion criteria (7 listed)
- Smoking;
- Participating in another trial that requires blood collection;
- Diagnosed with any chronic illness (including diabetes, hypertension etc.);
- On long term prescribed medication (except contraceptives);
- Pregnant or lactating;
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 |
|---|---|---|
| Enriched pomegranate juicePure pomegranate juice enriched with grape seed and apple peel extract (200 ml) to be consumed with 109 g of bread | Dietary supplement | Enriched pomegranate juice |
| Placebo beverageBeverage containing the same type and amount of carbohydrates as pomegranate juice and similar flavor (200 ml) to be consumed with 109 g of bread | Dietary supplement | Placebo beverage |
Primary outcome
Changes in maximal incremental plasma glucose level (iCmax) between baseline and endpoint within the intervention group vs. placebo control.
Time frame: Baseline, 15 min, 30 min, 45 min, 60 min, 90 min, 120 min, 150 min, 180 min.
The incremental glucose levels will be determined for each time point (at 15, 30, 45, 60, 90, 120, 150 and 180 min) as the change in plasma glucose levels after the consumption of enriched pomegranate juice or placebo drink concomitantly with white bread, compared to the glucose levels before the consumption of test meals (baseline value, t=0min).
4 secondary outcomes
Changes in area under the curve of incremental plasma glucose levels (iAUC) in the intervention group vs. placebo control.
Time frame: Baseline, 15 min, 30 min, 45 min, 60 min, 90 min, 120 min, 150 min, 180 min.
Changes in plasma insulin levels between baseline and endpoint within the intervention group vs. placebo control.
Time frame: Baseline, 15 min, 30 min, 45 min, 60 min, 90 min, 120 min, 150 min, 180 min.
Changes in plasma gastric inhibitory peptide (GIP) levels between baseline and endpoint within the intervention group vs. placebo control.
Time frame: Baseline, 15 min, 30 min, 45 min, 60 min, 90 min, 120 min, 150 min, 180 min.
Changes in glucagon-like peptide-1 (GIP-1) levels between baseline and endpoint within the intervention group vs. placebo control.
Time frame: Baseline, 15 min, 30 min, 45 min, 60 min, 90 min, 120 min, 150 min, 180 min.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2018.
- Individual participant dataSharing planned: Yes
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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.
Gary Williamson, PhD study chair
University of Leeds
Aleksandra Konic Ristic, PhD principal investigator
University of Leeds
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enriched pomegranate juice in people with Hyperglycemia, Postprandial and Healthy, run by University of Leeds 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 3 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 28 Jun 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gary Williamson, PhD (+441133438380, G.Williamson@leeds.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in maximal incremental plasma glucose level (iCmax) between baseline and endpoint within the intervention group vs. placebo control. (time frame: Baseline, 15 min, 30 min, 45 min, 60 min, 90 min, 120 min, 150 min, 180 min.). 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 28 Jun 2018.