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Effect of Drinks Containing Fruit Polyphenol Extracts and Fibre on Postprandial Glycaemia. (Glu-MIX)

Effect of Drinks Containing Fruit Polyphenol Extracts and Fibre on Postprandial Glycaemia. The Glu-MIX Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03572296
Enrollment
38
Registered
2018-06-28
Start date
2018-06-25
Completion date
2019-01-28
Last updated
2019-01-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postprandial Period

Keywords

Blackcurrant, Polyphenols, Pulp, Fibre, Glucose, Postprandial, Metabolism, Cognition

Brief 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 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.

Interventions

DIETARY_SUPPLEMENTFibre

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.

DIETARY_SUPPLEMENTPlacebo

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.

DIETARY_SUPPLEMENTPolyphenol and fibre

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.

Sponsors

King's College London
CollaboratorOTHER
Lucozade Ribena Suntory
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)

Intervention model description

Cross-over design. Each participant receives placebo plus 2 treatments.

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes

Inclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Postprandial glycaemia (iAUC 0-30 min)30 minThe primary endpoint is iAUC 0-30 min for plasma glucose concentrations

Secondary

MeasureTime frameDescription
Postprandial insulinemia: Tmax150 minTmax for serum insulin concentrations
Postprandial blood glucose-dependent insulinotropic peptide (GIP): iAUC 0-120 min120 miniAUC 0-120 min for plasma GIP concentrations
Postprandial blood glucose-dependent insulinotropic peptide (GIP): iAUC 0-150 min150 miniAUC 0-150 min for plasma GIP concentrations
Postprandial blood glucose-dependent insulinotropic peptide (GIP): iCmax150 miniCmax, for plasma GIP concentrations
Postprandial blood glucose-dependent insulinotropic peptide (GIP): Tmax150 minTmax for plasma GIP concentrations
Postprandial blood glucose-dependent insulinotropic peptide (GIP): Absolute concentrations at specific time points150 minAbsolute concentrations at specific time points, for plasma GIP concentrations
Cognitive function test scoresBefore and after 150 min blood collectionDescriptive statistics
Postprandial glycaemia: iAUC 0-120 min120 miniAUC 0-120 min for plasma glucose concentrations
Postprandial glycaemia: iAUC 0-150 min150 miniAUC 0-150 min for plasma glucose concentrations
Postprandial glycaemia: iCmax150 miniCmax for plasma glucose concentrations
Postprandial glycaemia: Tmax150 minTmax for plasma glucose concentrations
Postprandial glycaemia: absolute concentrations at specific time points150 minAbsolute concentrations at specific time points, for plasma glucose concentrations
Postprandial insulinemia: iAUC 0-30 min30 miniAUC 0-30 min for serum insulin concentrations
Postprandial insulinemia: iAUC 0-120 min120 miniAUC 0-120 min for serum insulin concentrations
Postprandial insulinemia: iAUC 0-150 min150 miniAUC 0-150 min for serum insulin concentrations
Postprandial insulinemia: iCmax150 miniCmax, for serum insulin concentrations
Postprandial insulinemia: absolute concentrations at specific time points150 minAbsolute concentrations at specific time points, for serum insulin concentrations
Postprandial C-peptide: iAUC 0-30 min30 miniAUC 0-30 min for plasma C-peptide concentrations
Postprandial C-peptide: iAUC 0-120 min120 miniAUC 0-120 min for plasma C-peptide concentrations
Postprandial C-peptide: iAUC 0-150 min150 miniAUC 0-150 min for plasma C-peptide concentrations
Postprandial C-peptide: iCmax150 miniCmax for plasma C-peptide concentrations
Postprandial C-peptide: Tmax150 minTmax for plasma C-peptide concentrations
Postprandial C-peptide: Absolute concentrations at specific time points150 minAbsolute concentrations at specific time points, for plasma C-peptide concentrations
Postprandial blood glucose-dependent insulinotropic peptide (GIP): iAUC 0-30 min30 miniAUC 0-30 min for plasma GIP concentrations

Other

MeasureTime frameDescription
100 mm visual analogue scale (VAS) measures of mood, satiety and digestive comfort150 minFor each VAS, a numerical score between 0 (not at all) and 100 (extremely) mm was obtained.
Ad libitum energy intake15 minEnergy intake during ad libitum meal
100 mm visual analogue scale (VAS) measures of the palatability of the ad libitum meal15 min following the ad libitum mealFor each VAS, a numerical score between 0 (not at all) and 100 (extremely) mm was obtained.
Buccal mouth swabOne off sample, collected at the first 1 day of study visitFuture exploratory analysis of lactase activity via the derived allele at the European
100 mm visual analogue scale (VAS) measures of the palatability of the study drink10 min following the test drinkFor each VAS, a numerical score between 0 (not at all) and 100 (extremely) mm was obtained.
7-d food diary (estimated/unweighed)7-daysHabitual dietary intake analysis

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 9, 2026