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Completed

NCT Number: NCT03572296

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

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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Key information

Conditions

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Metabolic Research Unit

London, SE1 9NH, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Exclusion criteria

  • 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.
  • 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.

Treatment and study plan

Placebo

Dietary 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 fibre

Dietary 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.

Fibre

Dietary 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.

Primary outcomes

  1. Postprandial glycaemia (iAUC 0-30 min)

    Time frame: 30 min

    The primary endpoint is iAUC 0-30 min for plasma glucose concentrations

Secondary outcomes

  1. Postprandial glycaemia: iAUC 0-120 min

    Time frame: 120 min

    iAUC 0-120 min for plasma glucose concentrations

  2. Postprandial glycaemia: iAUC 0-150 min

    Time frame: 150 min

    iAUC 0-150 min for plasma glucose concentrations

  3. Postprandial glycaemia: iCmax

    Time frame: 150 min

    iCmax for plasma glucose concentrations

  4. Postprandial glycaemia: Tmax

    Time frame: 150 min

    Tmax for plasma glucose concentrations

  5. Postprandial glycaemia: absolute concentrations at specific time points

    Time frame: 150 min

    Absolute concentrations at specific time points, for plasma glucose concentrations

  6. Postprandial insulinemia: iAUC 0-30 min

    Time frame: 30 min

    iAUC 0-30 min for serum insulin concentrations

  7. Postprandial insulinemia: iAUC 0-120 min

    Time frame: 120 min

    iAUC 0-120 min for serum insulin concentrations

  8. Postprandial insulinemia: iAUC 0-150 min

    Time frame: 150 min

    iAUC 0-150 min for serum insulin concentrations

  9. Postprandial insulinemia: iCmax

    Time frame: 150 min

    iCmax, for serum insulin concentrations

  10. Postprandial insulinemia: Tmax

    Time frame: 150 min

    Tmax for serum insulin concentrations

  11. Postprandial insulinemia: absolute concentrations at specific time points

    Time frame: 150 min

    Absolute concentrations at specific time points, for serum insulin concentrations

  12. Postprandial C-peptide: iAUC 0-30 min

    Time frame: 30 min

    iAUC 0-30 min for plasma C-peptide concentrations

  13. Postprandial C-peptide: iAUC 0-120 min

    Time frame: 120 min

    iAUC 0-120 min for plasma C-peptide concentrations

  14. Postprandial C-peptide: iAUC 0-150 min

    Time frame: 150 min

    iAUC 0-150 min for plasma C-peptide concentrations

  15. Postprandial C-peptide: iCmax

    Time frame: 150 min

    iCmax for plasma C-peptide concentrations

  16. Postprandial C-peptide: Tmax

    Time frame: 150 min

    Tmax for plasma C-peptide concentrations

  17. Postprandial C-peptide: Absolute concentrations at specific time points

    Time frame: 150 min

    Absolute concentrations at specific time points, for plasma C-peptide concentrations

  18. Postprandial blood glucose-dependent insulinotropic peptide (GIP): iAUC 0-30 min

    Time frame: 30 min

    iAUC 0-30 min for plasma GIP concentrations

  19. Postprandial blood glucose-dependent insulinotropic peptide (GIP): iAUC 0-120 min

    Time frame: 120 min

    iAUC 0-120 min for plasma GIP concentrations

  20. Postprandial blood glucose-dependent insulinotropic peptide (GIP): iAUC 0-150 min

    Time frame: 150 min

    iAUC 0-150 min for plasma GIP concentrations

  21. Postprandial blood glucose-dependent insulinotropic peptide (GIP): iCmax

    Time frame: 150 min

    iCmax, for plasma GIP concentrations

  22. Postprandial blood glucose-dependent insulinotropic peptide (GIP): Tmax

    Time frame: 150 min

    Tmax for plasma GIP concentrations

  23. Postprandial blood glucose-dependent insulinotropic peptide (GIP): Absolute concentrations at specific time points

    Time frame: 150 min

    Absolute concentrations at specific time points, for plasma GIP concentrations

  24. Cognitive function test scores

    Time frame: Before and after 150 min blood collection

    Descriptive statistics

Other outcomes

  1. 7-d food diary (estimated/unweighed)

    Time frame: 7-days

    Habitual dietary intake analysis

  2. 100 mm visual analogue scale (VAS) measures of the palatability of the study drink

    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.

  3. 100 mm visual analogue scale (VAS) measures of mood, satiety and digestive comfort

    Time frame: 150 min

    For each VAS, a numerical score between 0 (not at all) and 100 (extremely) mm was obtained.

  4. Ad libitum energy intake

    Time frame: 15 min

    Energy intake during ad libitum meal

  5. 100 mm visual analogue scale (VAS) measures of the palatability of the 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.

  6. Buccal mouth swab

    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

Sponsors and collaborators

Lead sponsor

Lucozade Ribena Suntory

Industry

Collaborators

  • King's College London

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jun 28, 2018
Registry last updated
Jan 31, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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