Postprandial PeriodNCT03572296
Effect of Drinks Containing Fruit Polyphenol Extracts and Fibre on Postprandial Glycaemia. (Glu-MIX)
A study testing Polyphenol and fibre and Fibre in people with Postprandial Period, run by Lucozade Ribena Suntory at 1 site in United Kingdom.
Trial summary
Postprandial glycaemia refers to the transient rise in blood glucose levels that occurs after consuming a meal. Large fluctuations in blood glucose levels, experienced on a frequent basis, may impair the functioning of pancreatic beta cells, and thus elevate the risk of developing type 2 diabetes mellitus (T2DM) and… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Postprandial Period
- What is being tested?
- Polyphenol and fibre and Fibre
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 38 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 25 Jun 2018to 28 Jan 2019
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age: 18-70 years
- Men and women
- 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 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 breastfeeding
- 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/ high fibre foods for 48 h before the study
- Weight change >3 kg in preceding 2 months
- 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). 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.
About this study
Official title: Effect of Drinks Containing Fruit Polyphenol Extracts and Fibre on Postprandial Glycaemia. The Glu-MIX Study
Postprandial glycaemia refers to the transient rise in blood glucose levels that occurs after consuming a meal. Large fluctuations in blood glucose levels, experienced on a frequent basis, may impair the functioning of pancreatic beta cells, and thus elevate the risk of developing type 2 diabetes mellitus (T2DM) and cardiovascular disease. Our group has previously shown that consuming a drink containing fruit polyphenols immediately before a meal, may reduce postprandial glycaemia. Importantly, other fruit components, namely soluble fibres, also impact on carbohydrate digestion by slowing gastric emptying rates. Combining fruit polyphenols and fibre in a drink may, potentially, have additive or synergistic effects on reducing postprandial glycaemia.
This study will investigate the effects of drinks containing blackcurrant polyphenol extract combined with pulp (source of fibre), and pulp alone, on postprandial outcomes and cognitive function following a mixed carbohydrate (starch and sucrose) test meal.
Read the detailed description
Intake of carbohydrate-rich foods transiently increases blood glucose levels (known as postprandial glycaemia). Repeated, high, postprandial glucose responses are evidenced to impair pancreatic beta cell function, thus increasing the risk of developing type-2 diabetes mellitus and cardiovascular disease. Therefore, meals that elicit a reduced, or more gradual, rise in blood glucose levels are desirable.
Previous studies have shown that consuming a drink containing fruit polyphenols, such as those from blackcurrants (BC), immediately before a high carbohydrate meal, reduced the postprandial glycaemic response. Importantly, other fruit components, namely soluble fibres, also impact on carbohydrate digestion by slowing gastric emptying rates. It is not yet known the effect of combining fibre and polyphenols on postprandial glycaemia. Although limited, there is a growing body of evidence showing beneficial acute effects of polyphenols in cognitive function which is of great interest in many work and academic environments where fast cognitive enhancement is wanted to perform a task or an exam.
This study will investigate the effects of drinks containing BC polyphenol extract combined with pulp (source of fibre), and pulp alone, on postprandial outcomes and cognitive function following a mixed carbohydrate (starch and sucrose) test meal.
Study design: A randomised, controlled, double-blind, cross-over study, of the healthy adult UK population, will be conducted. All subjects will receive the placebo drink, pulp only drink and the pulp with polyphenol drink in a random order. Baseline (fasted) blood samples will be taken before consuming the test drink (T0 min). Immediately following consumption of the drink, a mixed carbohydrate test meal will be consumed. Further blood samples will be collected at regular times until T150 min. Blood samples will be analysed for plasma glucose, insulin, glucose-dependent insulinotropic peptide (GIP) and C-peptide. Subjects will also perform a 30 min computer based cognitive performance test at baseline (T-45 min) and endpoint (T165 min). Visual analogue scales will be used to assess the effect of the test drinks on a range of sensory characteristics e.g. palatability, satiety and subjective mood feelings. Finally, an ad libitum pasta meal at the end of the study visit (T 215 min) will be used to assess the effects on energy intake.
- Conditions
- Postprandial Period
- Being tested
- Placebo, Polyphenol and fibre, Fibre
- Keywords
- Blackcurrant, Polyphenols, Pulp, Fibre, Glucose, Postprandial, Metabolism, Cognition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDietary supplement
Drinks will be delivered in random order at 3 separate study visits immediately before a high carbohydrate meal. A minimum of 4 days (ideally 7 days) wash-out period will be required between study days.
Polyphenol and fibreDietary supplement
Drinks will be delivered in random order at 3 separate study visits immediately before a high carbohydrate meal. A minimum of 4 days (ideally 7 days) wash-out period will be required between study days.
FibreDietary supplement
Drinks will be delivered in random order at 3 separate study visits immediately before a high carbohydrate meal. A minimum of 4 days (ideally 7 days) wash-out period will be required between study days.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | No polyphenols or fibre will be delivered in a low sugar drink. Receives: Dietary Supplement: Placebo |
| Polyphenol and fibre | Experimental | Blackcurrant extract (800 mg total polyphenols) and pulp (source of fibre) will be delivered in a low sugar drink. Receives: Dietary Supplement: Polyphenol and fibre |
| Fibre | Experimental | Pulp (source of fibre) will be delivered in a low sugar drink. Receives: Dietary Supplement: Fibre |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postprandial glycaemia (iAUC 0-30 min)
The primary endpoint is iAUC 0-30 min for plasma glucose concentrations
Measured: 30 min
Secondary outcomes (24)
Postprandial glycaemia: iAUC 0-120 min
iAUC 0-120 min for plasma glucose concentrations
Measured: 120 min
Postprandial glycaemia: iAUC 0-150 min
iAUC 0-150 min for plasma glucose concentrations
Measured: 150 min
Postprandial glycaemia: iCmax
iCmax for plasma glucose concentrations
Measured: 150 min
Postprandial glycaemia: Tmax
Tmax for plasma glucose concentrations
Measured: 150 min
Postprandial glycaemia: absolute concentrations at specific time points
Absolute concentrations at specific time points, for plasma glucose concentrations
Measured: 150 min
Postprandial insulinemia: iAUC 0-30 min
iAUC 0-30 min for serum insulin concentrations
Measured: 30 min
Postprandial insulinemia: iAUC 0-120 min
iAUC 0-120 min for serum insulin concentrations
Measured: 120 min
Postprandial insulinemia: iAUC 0-150 min
iAUC 0-150 min for serum insulin concentrations
Measured: 150 min
Postprandial insulinemia: iCmax
iCmax, for serum insulin concentrations
Measured: 150 min
Postprandial insulinemia: Tmax
Tmax for serum insulin concentrations
Measured: 150 min
Postprandial insulinemia: absolute concentrations at specific time points
Absolute concentrations at specific time points, for serum insulin concentrations
Measured: 150 min
Postprandial C-peptide: iAUC 0-30 min
iAUC 0-30 min for plasma C-peptide concentrations
Measured: 30 min
Postprandial C-peptide: iAUC 0-120 min
iAUC 0-120 min for plasma C-peptide concentrations
Measured: 120 min
Postprandial C-peptide: iAUC 0-150 min
iAUC 0-150 min for plasma C-peptide concentrations
Measured: 150 min
Postprandial C-peptide: iCmax
iCmax for plasma C-peptide concentrations
Measured: 150 min
Postprandial C-peptide: Tmax
Tmax for plasma C-peptide concentrations
Measured: 150 min
Postprandial C-peptide: Absolute concentrations at specific time points
Absolute concentrations at specific time points, for plasma C-peptide concentrations
Measured: 150 min
Postprandial blood glucose-dependent insulinotropic peptide (GIP): iAUC 0-30 min
iAUC 0-30 min for plasma GIP concentrations
Measured: 30 min
Postprandial blood glucose-dependent insulinotropic peptide (GIP): iAUC 0-120 min
iAUC 0-120 min for plasma GIP concentrations
Measured: 120 min
Postprandial blood glucose-dependent insulinotropic peptide (GIP): iAUC 0-150 min
iAUC 0-150 min for plasma GIP concentrations
Measured: 150 min
Postprandial blood glucose-dependent insulinotropic peptide (GIP): iCmax
iCmax, for plasma GIP concentrations
Measured: 150 min
Postprandial blood glucose-dependent insulinotropic peptide (GIP): Tmax
Tmax for plasma GIP concentrations
Measured: 150 min
Postprandial blood glucose-dependent insulinotropic peptide (GIP): Absolute concentrations at specific time points
Absolute concentrations at specific time points, for plasma GIP concentrations
Measured: 150 min
Cognitive function test scores
Descriptive statistics
Measured: Before and after 150 min blood collection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2018
- Study start25 Jun 2018
- Primary completion28 Jan 2019
- Study completion28 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Postprandial PeriodStudies 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
- Model description
- Cross-over design. Each participant receives placebo plus 2 treatments.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lucozade Ribena Suntory
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- King's College London
- Responsible party
- Sponsor
- Investigators
- Wendy L Hall, PhD, Principal investigator, King's College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03572296
- Sponsor's protocol ID
- HVS-010
- Status last verified
- Jan 2019
- First submitted
- 19 Jun 2018
- Last updated
- 31 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Castro-Acosta ML, Smith L, Miller RJ, McCarthy DI, Farrimond JA, Hall WL. Drinks containing anthocyanin-rich blackcurrant extract decrease postprandial blood glucose, insulin and incretin concentrations. J Nutr Biochem. 2016 Dec;38:154-161. doi: 10.1016/j.jnutbio.2016.09.002. Epub 2016 Sep 14.
PubMed 27764725Pinto AM, Hobden MR, Brown KD, Farrimond J, Targett D, Corpe CP, Ellis PR, Todorova Y, Socha K, Bahsoon S, Haworth C, Marcel M, Nie X, Hall WL. Acute effects of drinks containing blackcurrant and citrus (poly)phenols and dietary fibre on postprandial glycaemia, gut hormones, cognitive function and appetite in healthy adults: two randomised controlled trials. Food Funct. 2023 Nov 13;14(22):10163-10176. doi: 10.1039/d3fo03085g.
PubMed 37902089
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Drinks Containing Fruit Polyphenol Extracts and Fibre on Postprandial Glycaemia. The Glu-MIX Study
- ClinicalTrials.gov ID
- NCT03572296
- Acronym / sponsor ID
- HVS-010
- Conditions
- Postprandial Period
- Keywords
- Blackcurrant, Polyphenols, Pulp, Fibre, Glucose, Postprandial, Metabolism, Cognition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Lucozade Ribena SuntoryIndustry (pharma, biotech, devices)
- Collaborators
- King's College London
- Study start
- 25 Jun 2018 (actual)
- Primary completion
- 28 Jan 2019 (actual)
- Study completion
- 28 Jan 2019 (actual)
- First posted
- 28 Jun 2018 (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.
Postprandial glycaemia refers to the transient rise in blood glucose levels that occurs after consuming a meal. Large fluctuations in blood glucose levels, experienced on a frequent basis, may impair the functioning of pancreatic beta cells, and thus elevate the risk of developing type 2 diabetes mellitus (T2DM) and cardiovascular disease. Our group has previously shown that consuming a drink containing fruit polyphenols immediately before a meal, may reduce postprandial glycaemia. Importantly, other fruit components, namely soluble fibres, also impact on carbohydrate digestion by slowing gastric emptying rates. Combining fruit polyphenols and fibre in a drink may, potentially, have additive or synergistic effects on reducing postprandial glycaemia.
This study will investigate the effects of drinks containing blackcurrant polyphenol extract combined with pulp (source of fibre), and pulp alone, on postprandial outcomes and cognitive function following a mixed carbohydrate (starch and sucrose) test meal.
Detailed description
Intake of carbohydrate-rich foods transiently increases blood glucose levels (known as postprandial glycaemia). Repeated, high, postprandial glucose responses are evidenced to impair pancreatic beta cell function, thus increasing the risk of developing type-2 diabetes mellitus and cardiovascular disease. Therefore, meals that elicit a reduced, or more gradual, rise in blood glucose levels are desirable.
Previous studies have shown that consuming a drink containing fruit polyphenols, such as those from blackcurrants (BC), immediately before a high carbohydrate meal, reduced the postprandial glycaemic response. Importantly, other fruit components, namely soluble fibres, also impact on carbohydrate digestion by slowing gastric emptying rates. It is not yet known the effect of combining fibre and polyphenols on postprandial glycaemia. Although limited, there is a growing body of evidence showing beneficial acute effects of polyphenols in cognitive function which is of great interest in many work and academic environments where fast cognitive enhancement is wanted to perform a task or an exam.
This study will investigate the effects of drinks containing BC polyphenol extract combined with pulp (source of fibre), and pulp alone, on postprandial outcomes and cognitive function following a mixed carbohydrate (starch and sucrose) test meal.
Study design: A randomised, controlled, double-blind, cross-over study, of the healthy adult UK population, will be conducted. All subjects will receive the placebo drink, pulp only drink and the pulp with polyphenol drink in a random order. Baseline (fasted) blood samples will be taken before consuming the test drink (T0 min). Immediately following consumption of the drink, a mixed carbohydrate test meal will be consumed. Further blood samples will be collected at regular times until T150 min. Blood samples will be analysed for plasma glucose, insulin, glucose-dependent insulinotropic peptide (GIP) and C-peptide. Subjects will also perform a 30 min computer based cognitive performance test at baseline (T-45 min) and endpoint (T165 min). Visual analogue scales will be used to assess the effect of the test drinks on a range of sensory characteristics e.g. palatability, satiety and subjective mood feelings. Finally, an ad libitum pasta meal at the end of the study visit (T 215 min) will be used to assess the effects on energy intake.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- Cross-over design. Each participant receives placebo plus 2 treatments.
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: PlaceboNo polyphenols or fibre will be delivered in a low sugar drink. |
| Polyphenol and fibre | Experimental | Dietary Supplement: Polyphenol and fibreBlackcurrant extract (800 mg total polyphenols) and pulp (source of fibre) will be delivered in a low sugar drink. |
| Fibre | Experimental | Dietary Supplement: FibrePulp (source of fibre) will be 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 years
- Men and women
- 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 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 breastfeeding
- 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 |
|---|---|---|
| PlaceboDrinks will be delivered in random order at 3 separate study visits immediately before a high carbohydrate meal. A minimum of 4 days (ideally 7 days) wash-out period will be required between study days. | Dietary supplement | Placebo |
| Polyphenol and fibreDrinks will be delivered in random order at 3 separate study visits immediately before a high carbohydrate meal. A minimum of 4 days (ideally 7 days) wash-out period will be required between study days. | Dietary supplement | Polyphenol and fibre |
| FibreDrinks will be delivered in random order at 3 separate study visits immediately before a high carbohydrate meal. A minimum of 4 days (ideally 7 days) wash-out period will be required between study days. | Dietary supplement | Fibre |
Primary outcome
Postprandial glycaemia (iAUC 0-30 min)
Time frame: 30 min
The primary endpoint is iAUC 0-30 min for plasma glucose concentrations
24 secondary outcomes
Postprandial glycaemia: iAUC 0-120 min
Time frame: 120 min
Postprandial glycaemia: iAUC 0-150 min
Time frame: 150 min
Postprandial glycaemia: iCmax
Time frame: 150 min
Postprandial glycaemia: Tmax
Time frame: 150 min
Postprandial glycaemia: absolute concentrations at specific time points
Time frame: 150 min
Postprandial insulinemia: iAUC 0-30 min
Time frame: 30 min
Postprandial insulinemia: iAUC 0-120 min
Time frame: 120 min
Postprandial insulinemia: iAUC 0-150 min
Time frame: 150 min
Postprandial insulinemia: iCmax
Time frame: 150 min
Postprandial insulinemia: Tmax
Time frame: 150 min
Postprandial insulinemia: absolute concentrations at specific time points
Time frame: 150 min
Postprandial C-peptide: iAUC 0-30 min
Time frame: 30 min
Postprandial C-peptide: iAUC 0-120 min
Time frame: 120 min
Postprandial C-peptide: iAUC 0-150 min
Time frame: 150 min
Postprandial C-peptide: iCmax
Time frame: 150 min
Postprandial C-peptide: Tmax
Time frame: 150 min
Postprandial C-peptide: Absolute concentrations at specific time points
Time frame: 150 min
Postprandial blood glucose-dependent insulinotropic peptide (GIP): iAUC 0-30 min
Time frame: 30 min
Postprandial blood glucose-dependent insulinotropic peptide (GIP): iAUC 0-120 min
Time frame: 120 min
Postprandial blood glucose-dependent insulinotropic peptide (GIP): iAUC 0-150 min
Time frame: 150 min
Postprandial blood glucose-dependent insulinotropic peptide (GIP): iCmax
Time frame: 150 min
Postprandial blood glucose-dependent insulinotropic peptide (GIP): Tmax
Time frame: 150 min
Postprandial blood glucose-dependent insulinotropic peptide (GIP): Absolute concentrations at specific time points
Time frame: 150 min
Cognitive function test scores
Time frame: Before and after 150 min blood collection
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 31 Jan 2019.
- Background: PubMed 27764725Castro-Acosta ML, Smith L, Miller RJ, McCarthy DI, Farrimond JA, Hall WL. Drinks containing anthocyanin-rich blackcurrant extract decrease postprandial blood glucose, insulin and incretin concentrations. J Nutr Biochem. 2016 Dec;38:154-161. doi: 10.1016/j.jnutbio.2016.09.002. Epub 2016 Sep 14.
- Derived from this study: PubMed 37902089Pinto AM, Hobden MR, Brown KD, Farrimond J, Targett D, Corpe CP, Ellis PR, Todorova Y, Socha K, Bahsoon S, Haworth C, Marcel M, Nie X, Hall WL. Acute effects of drinks containing blackcurrant and citrus (poly)phenols and dietary fibre on postprandial glycaemia, gut hormones, cognitive function and appetite in healthy adults: two randomised controlled trials. Food Funct. 2023 Nov 13;14(22):10163-10176. doi: 10.1039/d3fo03085g.
- 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.
Wendy L Hall, PhD 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 Polyphenol and fibre and Fibre in people with Postprandial Period, run by Lucozade Ribena Suntory 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 31 Jan 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 (iAUC 0-30 min) (time frame: 30 min). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03572296, which also lists 2 linked publications.
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 31 Jan 2019.