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

NCT02940249 | Completed Results

• 1 other identifier: GLU-Pomme
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Prevention of Hyperglycaemia

Keywords

Polyphenol; Apple; Fruit; Hyperglycaemia; Metabolic

Outcome Measures

Primary Outcomes (1)

• Postprandial Glycaemia

  Primary outcome: Area over baseline t+0-30 min for plasma glucose

  30 min following the test drink

Secondary Outcomes (13)

• Postprandial Insulinaemia

  baseline and 10, 20, 30, 45, 60, 75, 90, 120, 150, 180, 240 min following the test drink

• Postprandial Glucose-dependent Insulinotropic Polypeptide (GIP) Concentrations

  baseline and 10, 20, 30, 45, 60, 75, 90, 120, 150, 180, 240 min following the test drink

• Postprandial Glucagon-like Peptide-1 (GLP-1) Concentrations

  baseline and 10, 20, 30, 45, 60, 75, 90, 120, 150, 180, 240 min following the test drink

• Postprandial C-peptide Concentrations

  baseline and 10, 20, 30, 45, 60, 75, 90, 120, 150, 180, 240 min following the test drink

• Postprandial Non-esterified Fatty Acid (NEFA) Concentrations

  baseline and 10, 20, 30, 45, 60, 75, 90, 120, 150, 180, 240 min following the test drink

Other Outcomes (2)

• 7-day Food Diary

  Baseline

• Women's Health Questionnaire

  Baseline

Study Arms (4)

1.2 g apple polyphenols

EXPERIMENTAL

1200 mg apple polyphenols delivered in a low sugar drink.

Dietary Supplement: Apple polyphenols

0.9 g apple polyphenols

EXPERIMENTAL

900 mg apple polyphenols delivered in a low sugar drink.

Dietary Supplement: Apple polyphenols

0.6 g apple polyphenols

EXPERIMENTAL

600 mg apple polyphenols delivered in a low sugar drink.

Dietary Supplement: Apple polyphenols

Placebo

PLACEBO COMPARATOR

No polyphenols delivered in a low sugar drink.

Dietary Supplement: Placebo

Interventions

Apple polyphenols DIETARY_SUPPLEMENT

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.

0.6 g apple polyphenols; 0.9 g apple polyphenols; 1.2 g apple polyphenols

Placebo DIETARY_SUPPLEMENT

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: 18-70 y
• Male and female

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• King's College London: lead
• DIANA Food: collaborator

Study Sites (1)

Metabolic Research Unit at King's College London

Waterloo Campus, London, SE1 9NH, United Kingdom

Location

MeSH Terms

Conditions

Hyperglycemia

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Results Point of Contact

• Title: Dr Wendy Hall
• Organization: King's College London

wendy.hall@kcl.ac.uk

020 7836 5454

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2016
• First Posted: October 20, 2016
• Study Start: January 1, 2017
• Primary Completion: November 1, 2017
• Study Completion: February 1, 2018
• Last Updated: June 17, 2020
• Results First Posted: June 17, 2020

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)