Metabolic Research Unit
London, SE1 9NH, United Kingdom
NCT Number: NCT03572296
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.
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Notify Me18 year–70 year
All sexes
Interventional
Not applicable
London, SE1 9NH, United Kingdom
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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.
Time frame: 30 min
The primary endpoint is iAUC 0-30 min for plasma glucose concentrations
Time frame: 120 min
iAUC 0-120 min for plasma glucose concentrations
Time frame: 150 min
iAUC 0-150 min for plasma glucose concentrations
Time frame: 150 min
iCmax for plasma glucose concentrations
Time frame: 150 min
Tmax for plasma glucose concentrations
Time frame: 150 min
Absolute concentrations at specific time points, for plasma glucose concentrations
Time frame: 30 min
iAUC 0-30 min for serum insulin concentrations
Time frame: 120 min
iAUC 0-120 min for serum insulin concentrations
Time frame: 150 min
iAUC 0-150 min for serum insulin concentrations
Time frame: 150 min
iCmax, for serum insulin concentrations
Time frame: 150 min
Tmax for serum insulin concentrations
Time frame: 150 min
Absolute concentrations at specific time points, for serum insulin concentrations
Time frame: 30 min
iAUC 0-30 min for plasma C-peptide concentrations
Time frame: 120 min
iAUC 0-120 min for plasma C-peptide concentrations
Time frame: 150 min
iAUC 0-150 min for plasma C-peptide concentrations
Time frame: 150 min
iCmax for plasma C-peptide concentrations
Time frame: 150 min
Tmax for plasma C-peptide concentrations
Time frame: 150 min
Absolute concentrations at specific time points, for plasma C-peptide concentrations
Time frame: 30 min
iAUC 0-30 min for plasma GIP concentrations
Time frame: 120 min
iAUC 0-120 min for plasma GIP concentrations
Time frame: 150 min
iAUC 0-150 min for plasma GIP concentrations
Time frame: 150 min
iCmax, for plasma GIP concentrations
Time frame: 150 min
Tmax for plasma GIP concentrations
Time frame: 150 min
Absolute concentrations at specific time points, for plasma GIP concentrations
Time frame: Before and after 150 min blood collection
Descriptive statistics
Time frame: 7-days
Habitual dietary intake analysis
Time frame: 10 min following the test drink
For each VAS, a numerical score between 0 (not at all) and 100 (extremely) mm was obtained.
Time frame: 150 min
For each VAS, a numerical score between 0 (not at all) and 100 (extremely) mm was obtained.
Time frame: 15 min
Energy intake during ad libitum meal
Time frame: 15 min following the ad libitum meal
For each VAS, a numerical score between 0 (not at all) and 100 (extremely) mm was obtained.
Time frame: One off sample, collected at the first 1 day of study visit
Future exploratory analysis of lactase activity via the derived allele at the European
Lucozade Ribena Suntory
Industry
Effect of Drinks Containing Fruit Polyphenol Extracts and Fibre on Postprandial Glycaemia. The Glu-MIX Study
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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