Postprandial PeriodGlu-FXNCT03184064
Acute Effects of Blackcurrant and Citrus Polyphenol Extracts on Postprandial Glycaemia
A study testing Blackcurrant extract (low dose), Citrus extract (low dose) and Blackcurrant extract (high dose) in people with Postprandial Period, run by Lucozade Ribena Suntory at 1 site in United Kingdom.
Trial summary
Large postprandial glucose responses are associated with increased risk of chronic diseases, including diabetes and cardiovascular disease. Our group have previously shown that fruit polyphenol extracts, when consumed immediately before a mixed carbohydrate meal, reduce postprandial glycaemia. 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?
- Blackcurrant extract (low dose), Citrus extract (low dose) and Blackcurrant extract (high dose)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 30 May 2017to 1 Jun 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 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 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
- 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: Acute Effects of Blackcurrant and Citrus Polyphenol Extracts on Postprandial Glycaemia: The Glu-FX Study
Large postprandial glucose responses are associated with increased risk of chronic diseases, including diabetes and cardiovascular disease. Our group have previously shown that fruit polyphenol extracts, when consumed immediately before a mixed carbohydrate meal, reduce postprandial glycaemia. The aim of this study is to investigate the effects of a blackcurrant polyphenol extract and citrus polyphenol extract (and their combination), on postprandial glycaemia, insulinaemia and gastrointestinal hormone concentrations following a mixed carbohydrate test meal. It is hypothesised that blackcurrant and citrus extracts alone will inhibit glycaemia compared to placebo, and a combination of the two will have a greater effect.
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 dysregulate functional proteins, oxidative stress and pancreatic beta cell function; thus increasing the risk of diabetes and cardiovascular disease. Accordingly, meals that elicit a reduced, or more gradual, rise in blood glucose levels are desirable. Fruit polyphenols may help to limit the glucose excursion following a high carbohydrate meal. Previous research by our group has demonstrated that blackcurrant polyphenols significantly inhibited the average incremental area under the curve (T+0 to +30 min) of plasma glucose. Possible mechanisms include inhibition of intestinal enzymes and inhibition of intestinal glucose absorption by decreasing Sodium-glucose linked transporter 1 (SGLT-1) / Glucose transporter 2 (GLUT-2) glucose transporter activity. In vitro data suggests that citrus polyphenols may impact on carbohydrate metabolism by binding to starch molecules, however, effects on postprandial glycaemia are not yet known. Blackcurrants and citrus fruits have distinct polyphenol profiles and may therefore act on glucose homeostasis via different mechanisms. Blackcurrants are rich in anthocyanins and flavanols, whereas citrus fruits are rich in flavanones, hesperetin and naringenin. Theoretically, combining blackcurrant with citrus extracts may have synergistic effects.
The aim of this study is to investigate the effects of blackcurrant polyphenol extracts and citrus polyphenol extracts (and their combination), on postprandial glycaemia, insulinaemia and gastrointestinal hormone concentrations following a mixed carbohydrate test meal. It is hypothesised that blackcurrant and citrus extracts alone will inhibit glycaemia compared to placebo, a combination of the two will have a greater effect.
Study design: A randomised, controlled, double-blind, cross-over study will be conducted. Subjects will consume different drinks at 4 separate study visits. Drinks will contain either: blackcurrant extract (low dose), blackcurrant extract (high dose), citrus extract (low dose), blackcurrant and citrus extract (low dose + low dose), or placebo (no polyphenols). The study will utilise an incomplete block design. Subjects will consume the placebo drink and 3 out of 4 of the polyphenol-containing drinks during the study. At least a 7-day wash-out period will be required between study days. Baseline (fasted) blood samples will be taken in duplicate at T-10 min and T-5 min before consuming the test drink (T+0 min). Immediately following consumption of the drink, a mixed carbohydrate test meal will be consumed. Further blood samples will be collected at 10 min intervals for the first 30 min and then every 15 min until T+90 min and at T+120 min. Blood samples will be analysed for plasma glucose, insulin, glucose-dependent insulinotropic peptide (GIP), glucagon-like peptide 1 (GLP-1), peptide YY (PYY), C-peptide and nonesterified fatty acids (NEFA).
- Conditions
- Postprandial Period
- Being tested
- Blackcurrant extract (low dose), Placebo, Citrus extract (low dose), Blackcurrant extract (high dose), Blackcurrant and citrus extracts (low dose / low dose)
- Keywords
- Blackcurrant, Citrus, Polyphenols, Glucose, Postprandial, Metabolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blackcurrant extract (low dose)Dietary supplement
Participants will consume a small beverage that contains blackcurrant extract (low dose) immediately before a high-carbohydrate meal.
PlaceboDietary supplement
Participants will consume a small beverage that contains no fruit extracts immediately before a high-carbohydrate meal.
Citrus extract (low dose)Dietary supplement
Participants will consume a small beverage that contains citrus extract (low dose) immediately before a high-carbohydrate meal.
Blackcurrant extract (high dose)Dietary supplement
Participants will consume a small beverage that contains blackcurrant extract (high dose) immediately before a high-carbohydrate meal.
Blackcurrant and citrus extracts (low dose / low dose)Dietary supplement
Participants will consume a small beverage that contains blackcurrant and citrus extracts (low dose / low dose)immediately before a high-carbohydrate meal.
| Study group | Role | What they receive |
|---|---|---|
| Treatment arm 1 | Experimental | Participants will receive the placebo, blackcurrant extract (low dose), blackcurrant extract (high dose), citrus extract (low dose) at 4 separate study visits, in a random order. Visits will be separated by at least 7 days. Receives: Dietary Supplement: Blackcurrant extract (low dose); Dietary Supplement: Placebo; Dietary Supplement: Citrus extract (low dose); Dietary Supplement: Blackcurrant extract (high dose) |
| Treatment arm 2 | Experimental | Participants will receive the placebo, citrus extract (low dose), blackcurrant extract (high dose), blackcurrant and citrus extracts (low dose / low dose) at 4 separate study visits, in a random order. Visits will be separated by at least 7 days. Receives: Dietary Supplement: Placebo; Dietary Supplement: Citrus extract (low dose); Dietary Supplement: Blackcurrant extract (high dose); Dietary Supplement: Blackcurrant and citrus extracts (low dose / low dose) |
| Treatment arm 3 | Experimental | Participants will receive the placebo, blackcurrant extract (low dose), blackcurrant extract (high dose), blackcurrant and citrus extracts (low dose / low dose) at 4 separate study visits, in a random order. Visits will be separated by at least 7 days. Receives: Dietary Supplement: Blackcurrant extract (low dose); Dietary Supplement: Placebo; Dietary Supplement: Blackcurrant extract (high dose); Dietary Supplement: Blackcurrant and citrus extracts (low dose / low dose) |
| Treatment arm 4 | Experimental | Participants will receive the placebo, blackcurrant extract (low dose), citrus extract (low dose), blackcurrant and citrus extracts (low dose / low dose) at 4 separate study visits, in a random order. Visits will be separated by at least 7 days. Receives: Dietary Supplement: Blackcurrant extract (low dose); Dietary Supplement: Placebo; Dietary Supplement: Citrus extract (low dose); Dietary Supplement: Blackcurrant and citrus extracts (low dose / low dose) |
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 (34)
Postprandial glycaemia: iAUC 0-120 min
iAUC 0-120 min for plasma glucose concentrations
Measured: 120 min
Postprandial glycaemia: iCmax
iCmax for plasma glucose concentrations
Measured: 120 min
Postprandial glycaemia: Tmax
Tmax for plasma glucose concentrations
Measured: 120 min
Postprandial glycaemia: absolute concentrations at specific time points
Absolute concentrations at specific time points, for plasma glucose concentrations
Measured: 120 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: iCmax
iCmax, for serum insulin concentrations
Measured: 120 min
Postprandial insulinemia: Tmax
Tmax for serum insulin concentrations
Measured: 120 min
Postprandial insulinemia: absolute concentrations at specific time points
Absolute concentrations at specific time points, for serum insulin concentrations
Measured: 120 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: 30 min
Postprandial C-peptide: iCmax
iCmax for plasma C-peptide concentrations
Measured: 120 min
Postprandial C-peptide: Tmax
Tmax for plasma C-peptide concentrations
Measured: 120 min
Postprandial C-peptide: Absolute concentrations at specific time points
Absolute concentrations at specific time points, for plasma C-peptide concentrations
Measured: 120 min
Postprandial non-esterified fatty acids (NEFA): iAUC 0-30 min
iAUC 0-30 min for serum NEFA concentrations
Measured: 30 min
Postprandial non-esterified fatty acids (NEFA): iAUC 0-120 min
iAUC 0-120 min for serum NEFA concentrations
Measured: 120 min
Postprandial non-esterified fatty acids (NEFA): iCmax
iCmax for serum NEFA concentrations
Measured: 120 min
Postprandial non-esterified fatty acids (NEFA): Tmax
Tmax for serum NEFA concentrations
Measured: 120 min
Postprandial non-esterified fatty acids (NEFA): Absolute concentrations at specific time points
Absolute concentrations at specific time points, for serum NEFA concentrations
Measured: 120 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): iCmax
iCmax, for plasma GIP concentrations
Measured: 120 min
Postprandial blood glucose-dependent insulinotropic peptide (GIP): Tmax
Tmax for plasma GIP concentrations
Measured: 120 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: 120 min
Postprandial blood Glucagon-like peptide 1 (GLP-1): iAUC 0-30 min
iAUC 0-30 min for plasma GLP-1 concentrations
Measured: 30 min
Postprandial blood Glucagon-like peptide 1 (GLP-1): iAUC 0-120 min
iAUC 0-120 min, for plasma GLP-1 concentrations
Measured: 120 min
Postprandial blood Glucagon-like peptide 1 (GLP-1): iCmax
iCmax for plasma GLP-1 concentrations
Measured: 120 min
Postprandial blood Glucagon-like peptide 1 (GLP-1): Tmax
Tmax for plasma GLP-1 concentrations
Measured: 30 min
Postprandial blood Glucagon-like peptide 1 (GLP-1): Absolute concentrations at specific time points
Absolute concentrations at specific time points, for plasma GLP-1 concentrations
Measured: 120 min
Postprandial blood peptide YY (PYY): iAUC 0-30 min
iAUC 0-30 min for plasma PYY concentrations
Measured: 30 min
Postprandial blood peptide YY (PYY): iAUC 0-120 min
iAUC 0-120 minfor plasma PYY concentrations
Measured: 120 min
Postprandial blood peptide YY (PYY): iCmax
iCmax for plasma PYY concentrations
Measured: 120 min
Postprandial blood peptide YY (PYY): Tmax
Tmax for plasma PYY concentrations
Measured: 120 min
Postprandial blood peptide YY (PYY): Absolute concentrations at specific time points
Absolute concentrations at specific time points, for plasma PYY concentrations
Measured: 120 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2017
- Study start30 May 2017
- Primary completion1 Feb 2018
- Study completion1 Jun 2018
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
- Incomplete block cross-over design. Each participant receives placebo plus 3 out of 4 active treatments.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 32 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
- NCT03184064
- Sponsor's protocol ID
- HVS-007
- Acronym
- Glu-FX
- Status last verified
- Aug 2018
- First submitted
- 23 May 2017
- Last updated
- 22 Aug 2018
- 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 22 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Effects of Blackcurrant and Citrus Polyphenol Extracts on Postprandial Glycaemia: The Glu-FX Study
- ClinicalTrials.gov ID
- NCT03184064
- Acronym / sponsor ID
- Glu-FX / HVS-007
- Conditions
- Postprandial Period
- Keywords
- Blackcurrant, Citrus, Polyphenols, Glucose, Postprandial, Metabolism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Lucozade Ribena SuntoryIndustry (pharma, biotech, devices)
- Collaborators
- King's College London
- Study start
- 30 May 2017 (actual)
- Primary completion
- 1 Feb 2018 (actual)
- Study completion
- 1 Jun 2018 (actual)
- First posted
- 12 Jun 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.
Large postprandial glucose responses are associated with increased risk of chronic diseases, including diabetes and cardiovascular disease. Our group have previously shown that fruit polyphenol extracts, when consumed immediately before a mixed carbohydrate meal, reduce postprandial glycaemia. The aim of this study is to investigate the effects of a blackcurrant polyphenol extract and citrus polyphenol extract (and their combination), on postprandial glycaemia, insulinaemia and gastrointestinal hormone concentrations following a mixed carbohydrate test meal. It is hypothesised that blackcurrant and citrus extracts alone will inhibit glycaemia compared to placebo, and a combination of the two will have a greater effect.
Detailed description
Intake of carbohydrate-rich foods transiently increases blood glucose levels (known as postprandial glycaemia). Repeated high postprandial glucose responses are evidenced to dysregulate functional proteins, oxidative stress and pancreatic beta cell function; thus increasing the risk of diabetes and cardiovascular disease. Accordingly, meals that elicit a reduced, or more gradual, rise in blood glucose levels are desirable. Fruit polyphenols may help to limit the glucose excursion following a high carbohydrate meal. Previous research by our group has demonstrated that blackcurrant polyphenols significantly inhibited the average incremental area under the curve (T+0 to +30 min) of plasma glucose. Possible mechanisms include inhibition of intestinal enzymes and inhibition of intestinal glucose absorption by decreasing Sodium-glucose linked transporter 1 (SGLT-1) / Glucose transporter 2 (GLUT-2) glucose transporter activity. In vitro data suggests that citrus polyphenols may impact on carbohydrate metabolism by binding to starch molecules, however, effects on postprandial glycaemia are not yet known. Blackcurrants and citrus fruits have distinct polyphenol profiles and may therefore act on glucose homeostasis via different mechanisms. Blackcurrants are rich in anthocyanins and flavanols, whereas citrus fruits are rich in flavanones, hesperetin and naringenin. Theoretically, combining blackcurrant with citrus extracts may have synergistic effects.
The aim of this study is to investigate the effects of blackcurrant polyphenol extracts and citrus polyphenol extracts (and their combination), on postprandial glycaemia, insulinaemia and gastrointestinal hormone concentrations following a mixed carbohydrate test meal. It is hypothesised that blackcurrant and citrus extracts alone will inhibit glycaemia compared to placebo, a combination of the two will have a greater effect.
Study design: A randomised, controlled, double-blind, cross-over study will be conducted. Subjects will consume different drinks at 4 separate study visits. Drinks will contain either: blackcurrant extract (low dose), blackcurrant extract (high dose), citrus extract (low dose), blackcurrant and citrus extract (low dose + low dose), or placebo (no polyphenols). The study will utilise an incomplete block design. Subjects will consume the placebo drink and 3 out of 4 of the polyphenol-containing drinks during the study. At least a 7-day wash-out period will be required between study days. Baseline (fasted) blood samples will be taken in duplicate at T-10 min and T-5 min before consuming the test drink (T+0 min). Immediately following consumption of the drink, a mixed carbohydrate test meal will be consumed. Further blood samples will be collected at 10 min intervals for the first 30 min and then every 15 min until T+90 min and at T+120 min. Blood samples will be analysed for plasma glucose, insulin, glucose-dependent insulinotropic peptide (GIP), glucagon-like peptide 1 (GLP-1), peptide YY (PYY), C-peptide and nonesterified fatty acids (NEFA).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
- Model description
- Incomplete block cross-over design. Each participant receives placebo plus 3 out of 4 active treatments.
| Arm | Type | Receives |
|---|---|---|
| Treatment arm 1 | Experimental | Dietary Supplement: Blackcurrant extract (low dose), Dietary Supplement: Placebo, Dietary Supplement: Citrus extract (low dose), Dietary Supplement: Blackcurrant extract (high dose)Participants will receive the placebo, blackcurrant extract (low dose), blackcurrant extract (high dose), citrus extract (low dose) at 4 separate study visits, in a random order. Visits will be separated by at least 7 days. |
| Treatment arm 2 | Experimental | Dietary Supplement: Placebo, Dietary Supplement: Citrus extract (low dose), Dietary Supplement: Blackcurrant extract (high dose), Dietary Supplement: Blackcurrant and citrus extracts (low dose / low dose)Participants will receive the placebo, citrus extract (low dose), blackcurrant extract (high dose), blackcurrant and citrus extracts (low dose / low dose) at 4 separate study visits, in a random order. Visits will be separated by at least 7 days. |
| Treatment arm 3 | Experimental | Dietary Supplement: Blackcurrant extract (low dose), Dietary Supplement: Placebo, Dietary Supplement: Blackcurrant extract (high dose), Dietary Supplement: Blackcurrant and citrus extracts (low dose / low dose)Participants will receive the placebo, blackcurrant extract (low dose), blackcurrant extract (high dose), blackcurrant and citrus extracts (low dose / low dose) at 4 separate study visits, in a random order. Visits will be separated by at least 7 days. |
| Treatment arm 4 | Experimental | Dietary Supplement: Blackcurrant extract (low dose), Dietary Supplement: Placebo, Dietary Supplement: Citrus extract (low dose), Dietary Supplement: Blackcurrant and citrus extracts (low dose / low dose)Participants will receive the placebo, blackcurrant extract (low dose), citrus extract (low dose), blackcurrant and citrus extracts (low dose / low dose) at 4 separate study visits, in a random order. Visits will be separated by at least 7 days. |
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 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 |
|---|---|---|
| Blackcurrant extract (low dose)Participants will consume a small beverage that contains blackcurrant extract (low dose) immediately before a high-carbohydrate meal. | Dietary supplement | Treatment arm 1, Treatment arm 3, Treatment arm 4 |
| PlaceboParticipants will consume a small beverage that contains no fruit extracts immediately before a high-carbohydrate meal. | Dietary supplement | Treatment arm 1, Treatment arm 2, Treatment arm 3, Treatment arm 4 |
| Citrus extract (low dose)Participants will consume a small beverage that contains citrus extract (low dose) immediately before a high-carbohydrate meal. | Dietary supplement | Treatment arm 1, Treatment arm 2, Treatment arm 4 |
| Blackcurrant extract (high dose)Participants will consume a small beverage that contains blackcurrant extract (high dose) immediately before a high-carbohydrate meal. | Dietary supplement | Treatment arm 1, Treatment arm 2, Treatment arm 3 |
| Blackcurrant and citrus extracts (low dose / low dose)Participants will consume a small beverage that contains blackcurrant and citrus extracts (low dose / low dose)immediately before a high-carbohydrate meal. | Dietary supplement | Treatment arm 2, Treatment arm 3, Treatment arm 4 |
Primary outcome
Postprandial glycaemia (iAUC 0-30 min)
Time frame: 30 min
The primary endpoint is iAUC 0-30 min for plasma glucose concentrations
34 secondary outcomes
Postprandial glycaemia: iAUC 0-120 min
Time frame: 120 min
Postprandial glycaemia: iCmax
Time frame: 120 min
Postprandial glycaemia: Tmax
Time frame: 120 min
Postprandial glycaemia: absolute concentrations at specific time points
Time frame: 120 min
Postprandial insulinemia: iAUC 0-30 min
Time frame: 30 min
Postprandial insulinemia: iAUC 0-120 min
Time frame: 120 min
Postprandial insulinemia: iCmax
Time frame: 120 min
Postprandial insulinemia: Tmax
Time frame: 120 min
Postprandial insulinemia: absolute concentrations at specific time points
Time frame: 120 min
Postprandial C-peptide: iAUC 0-30 min
Time frame: 30 min
Postprandial C-peptide: iAUC 0-120 min
Time frame: 30 min
Postprandial C-peptide: iCmax
Time frame: 120 min
Postprandial C-peptide: Tmax
Time frame: 120 min
Postprandial C-peptide: Absolute concentrations at specific time points
Time frame: 120 min
Postprandial non-esterified fatty acids (NEFA): iAUC 0-30 min
Time frame: 30 min
Postprandial non-esterified fatty acids (NEFA): iAUC 0-120 min
Time frame: 120 min
Postprandial non-esterified fatty acids (NEFA): iCmax
Time frame: 120 min
Postprandial non-esterified fatty acids (NEFA): Tmax
Time frame: 120 min
Postprandial non-esterified fatty acids (NEFA): Absolute concentrations at specific time points
Time frame: 120 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): iCmax
Time frame: 120 min
Postprandial blood glucose-dependent insulinotropic peptide (GIP): Tmax
Time frame: 120 min
Postprandial blood glucose-dependent insulinotropic peptide (GIP): Absolute concentrations at specific time points
Time frame: 120 min
Postprandial blood Glucagon-like peptide 1 (GLP-1): iAUC 0-30 min
Time frame: 30 min
Postprandial blood Glucagon-like peptide 1 (GLP-1): iAUC 0-120 min
Time frame: 120 min
Postprandial blood Glucagon-like peptide 1 (GLP-1): iCmax
Time frame: 120 min
Postprandial blood Glucagon-like peptide 1 (GLP-1): Tmax
Time frame: 30 min
Postprandial blood Glucagon-like peptide 1 (GLP-1): Absolute concentrations at specific time points
Time frame: 120 min
Postprandial blood peptide YY (PYY): iAUC 0-30 min
Time frame: 30 min
Postprandial blood peptide YY (PYY): iAUC 0-120 min
Time frame: 120 min
Postprandial blood peptide YY (PYY): iCmax
Time frame: 120 min
Postprandial blood peptide YY (PYY): Tmax
Time frame: 120 min
Postprandial blood peptide YY (PYY): Absolute concentrations at specific time points
Time frame: 120 min
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 22 Aug 2018.
- 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 Blackcurrant extract (low dose), Citrus extract (low dose) and Blackcurrant extract (high dose) 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 22 Aug 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. 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 NCT03184064, 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 22 Aug 2018.