Effects of an Apple Extract on Glycaemia: The GLU-Pomme Study

Prevention of Hyperglycaemia Clinical Trial

— GLU-Pomme  

Official title:

Dose-response Effect of an Apple Extract on Postprandial Glycaemia: a Randomised Controlled Trial. The GLU-POMME Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02940249
• Other study ID #: GLU-Pomme
• Status: Completed
• Phase: N/A
• Start date: January 2017
• Est. completion date: February 2018

Study information

• Verified date: March 2018
• Source: King's College London
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Postprandial hyperglycaemia can lead to adverse modifications to functional proteins within the body and eventually lead to the development of type 2 diabetes. Previous research by this group has shown that an apple polyphenol extract reduced hyperglycaemia following a high-carbohydrate meal. The aim of this study is to investigate the effects of lower doses of the apple extract on postprandial glycaemia, insulinaemia and plasma gastric inhibitory polypeptide concentrations following a mixed carbohydrate test meal.

Description:

Introduction:

Sharp peaks in blood glucose levels can lead to adverse modifications to functional proteins, oxidative stress and pancreatic beta cell dysfunction. It is therefore desirable to consume a diet that will allow more gradual rises in blood glucose levels after meals. Fruit polyphenols may help to limit the glucose excursion following a high carbohydrate meal. Previous research by this research group has demonstrated that 1200 mg of apple polyphenols (Appl'In™) inhibited the average incremental area under the curve (T+0 to T+30 min) of plasma glucose by 54% relative to placebo. Possible mechanisms include inhibition of intestinal enzymes and inhibition of intestinal glucose absorption by decreasing SGLT1/GLUT2 transport activity. The literature also suggests that foods rich in polyphenols exert beneficial effects on risk factors of cardiovascular disease such as hypertension, lipid metabolism and vascular function.

Study design:

A randomised, controlled, double-blind, cross-over study will be conducted. Four matched test drinks will be consumed in random order on separate study visits immediately before a mixed-carbohydrate test meal, containing either: 1) 1.2 g, 2) 0.9 g 3). 0.6 g of apple polyphenols, or 4). placebo. Postprandial changes in plasma glucose, insulin, NEFA, GIP, GLP-1 concentrations as well as changes in vascular function will be measured. Twenty-four hour urine samples will be collected for analysis of urinary polyphenol metabolites and glucose. In a sub sample of participants, a paracetamol absorption test will be incorporated via addition of 1.5 g paracetamol into the test drink.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: February 2018
• Est. primary completion date: November 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Age: 18-70 y

• Male and female

• 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 and/or paracetamol 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.

• 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 and body mass index <18 or >35 kg/m2

• 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); and medications that may react unpredictably with paracetamol: ketoconazole, metoclopramide, carbamazepine, phenobarbital, phenytoin, primidone, warfarin and other products containing paracetamol. 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.

Related Conditions & MeSH terms

• Hyperglycemia
• Prevention of Hyperglycaemia

Intervention

Dietary Supplement:
• Apple polyphenols
Drinks will be delivered in random order at 4 separate study visits immediately before a high-carbohydrate meal. Seven days wash-out period will be required between study days.
• Placebo

Locations

Country	Name	City	State
United Kingdom	Metabolic Research Unit at King's College London	Waterloo Campus	London

Sponsors (2)

Lead Sponsor	Collaborator
King's College London	DIANA Food

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	7-day Food Diary	Habitual dietary intake analysis	Baseline
Other	Women's Health Questionnaire	Questionnaire to identify menstrual phase	Baseline
Primary	Postprandial Glycaemia	Primary outcome: Area over baseline t+0-30 min for plasma glucose	30 min following the test drink
Secondary	Postprandial Insulinaemia	Peak postprandial insulin concentrations (Cmax) t +0-30 min and change from baseline data and areas over baseline t+0-30 min and t+0-240 min.	baseline and 10, 20, 30, 45, 60, 75, 90, 120, 150, 180, 240 min following the test drink
Secondary	Postprandial Glucose-dependent Insulinotropic Polypeptide (GIP) Concentrations	Peak postprandial GIP concentrations (Cmax) t +0-30 min and change from baseline data and areas over baseline t+0-30 min and t+0-240 min.	baseline and 10, 20, 30, 45, 60, 75, 90, 120, 150, 180, 240 min following the test drink
Secondary	Postprandial Glucagon-like Peptide-1 (GLP-1) Concentrations	Peak postprandial GLP-1 concentrations (Cmax) t +0-30 min and change from baseline data and areas over baseline t+0-30 min and t+0-240 min.	baseline and 10, 20, 30, 45, 60, 75, 90, 120, 150, 180, 240 min following the test drink
Secondary	Postprandial C-peptide Concentrations	Peak postprandial C-peptide concentrations (Cmax) t +0-30 min and change from baseline data and areas over baseline t+0-30 min and t+0-240 min.	baseline and 10, 20, 30, 45, 60, 75, 90, 120, 150, 180, 240 min following the test drink
Secondary	Postprandial Non-esterified Fatty Acid (NEFA) Concentrations	Peak postprandial NEFA concentrations (Cmax) t +0-30 min and change from baseline data and areas over baseline t+0-30 min and t+0-240 min	baseline and 10, 20, 30, 45, 60, 75, 90, 120, 150, 180, 240 min following the test drink
Secondary	Postprandial Triglyceride (TAG) Concentrations	Peak postprandial TAG concentrations (Cmax) t +0-30 min and change from baseline data and areas over baseline t+0-30 min and t+0-240 min.	baseline and 10, 20, 30, 45, 60, 75, 90, 120, 150, 180, 240 min following the test drink
Secondary	Postprandial Paracetamol Concentrations	Peak postprandial paracetamol concentrations (Cmax) t +0-30 min and change from baseline data and areas over baseline t+0-30 min and t+0-240 min (1.5 g paracetamol will be added to all test drinks in a sub-group of participants).	baseline and 10, 20, 30, 45, 60, 75, 90, 120, 150, 180, 240 min following the test drink
Secondary	Postprandial Polyphenol Metabolite Concentrations	Peak postprandial polyphenol metabolites concentrations (Cmax) t +0-30 min and change from baseline data and areas over baseline t+0-30 min and t+0-240 min.	baseline and 10, 20, 30, 45, 60, 75, 90, 120, 150, 180, 240 min following the test drink
Secondary	Vascular Endothelial Function by Flow-mediated Dilation (FMD)	Change in FMD after the consumption of test drink.	baseline and 120, 240, 300 min following the test drink
Secondary	Vascular Function (Arteriograph Measurement)	Change in augmentation index following the test drink.	Baseline and 60, 90, 120, 180, 240 min following the test drink
Secondary	Blood Pressure	Change in blood pressure following the test drink.	Baseline and 60, 90, 120, 180, 240 min following the test drink
Secondary	Urinary Polyphenol Metabolites	Change in urinary polyphenol metabolite concentration following the test drink.	0-4 h, 4-8 h, 8-24 h following the test drink
Secondary	Urinary Glucose	Change in urinary glucose concentration following the test drink.	0-4 h, 4-8 h, 8-24 h following the test drink

External Links

•   Castro-Acosta et al. (2016). Drinks containing anthocyanin-rich blackcurrant extract decrease postprandial blood glucose, insulin and incretin concentrations. The Journal of Nutritional Biochemistry 38: 154-161.