Effects of Enriched Fruit Juice on Blood Glucose Levels After a Meal in Healthy Subjects

NCT03255876 | Unknown

• 1 other identifier: MEEC 16-011
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

Results from a large number of studies in humans have shown that diets rich in foods that give lower glucose response bring lower risk of type 2 diabetes. Polyphenols, naturally found in fruits, vegetables and grains, have shown the potential to attenuate post-prandial blood glucose spikes following a carbohydrate-rich meal, through partial inhibition of the main enzymes of carbohydrate digestion and reduction in glucose and fructose transport from the gut after digestion and by enhancing the insulin action after glucose reaches the bloodstream. This study is designed to determine whether polyphenols, as normally and naturally present in food extracts and beverages, added to a carbohydrate-rich meal, can lower blood glucose levels after its consumption, and hence lower its glycaemic index, and if this effect is mediated through effects on insulin and other hormones. The study is designed as an acute, double-blind, randomised, placebo-controlled crossover trial in 24 healthy subjects with normal glycaemic response to white bread. Participants will be asked to consume either white bread with pomegranate juice enriched with extracts from grape seeds and apple peels or white bread with placebo drink. The effects on plasma glucose levels, levels of hormones and other biomarkers involved in postprandial response will be determined over 3 hours after the consumption.

Conditions

Hyperglycemia, Postprandial; Healthy

Keywords

Polyphenols; Hyperglycemia; Postprandial; Starch; Alpha-amylase

Outcome Measures

Primary Outcomes (1)

• Changes in maximal incremental plasma glucose level (iCmax) between baseline and endpoint within the intervention group vs. placebo control.

  The incremental glucose levels will be determined for each time point (at 15, 30, 45, 60, 90, 120, 150 and 180 min) as the change in plasma glucose levels after the consumption of enriched pomegranate juice or placebo drink concomitantly with white bread, compared to the glucose levels before the consumption of test meals (baseline value, t=0min).

  Baseline, 15 min, 30 min, 45 min, 60 min, 90 min, 120 min, 150 min, 180 min.

Secondary Outcomes (4)

• Changes in area under the curve of incremental plasma glucose levels (iAUC) in the intervention group vs. placebo control.

  Baseline, 15 min, 30 min, 45 min, 60 min, 90 min, 120 min, 150 min, 180 min.

• Changes in plasma insulin levels between baseline and endpoint within the intervention group vs. placebo control.

  Baseline, 15 min, 30 min, 45 min, 60 min, 90 min, 120 min, 150 min, 180 min.

• Changes in plasma gastric inhibitory peptide (GIP) levels between baseline and endpoint within the intervention group vs. placebo control.

  Baseline, 15 min, 30 min, 45 min, 60 min, 90 min, 120 min, 150 min, 180 min.

• Changes in glucagon-like peptide-1 (GIP-1) levels between baseline and endpoint within the intervention group vs. placebo control.

  Baseline, 15 min, 30 min, 45 min, 60 min, 90 min, 120 min, 150 min, 180 min.

Other Outcomes (3)

• Changes in organic acids profile between baseline and endpoint within the intervention group vs. placebo control.

  Baseline, 15 min, 30 min, 45 min, 60 min, 90 min, 120 min, 150 min, 180 min.

• Changes in fatty acids profile between baseline and endpoint within the intervention group vs. placebo control.

  Baseline, 15 min, 30 min, 45 min, 60 min, 90 min, 120 min, 150 min, 180 min.

• Changes in triglycerides levels between baseline and endpoint within the intervention group vs. placebo control.

  Baseline, 15 min, 30 min, 45 min, 60 min, 90 min, 120 min, 150 min, 180 min.

Study Arms (2)

Enriched pomegranate juice

EXPERIMENTAL

Participants will consume 200 ml of pure pomegranate juice enriched with grape seed and apple peel extracts concomitantly with 109 g of white bread

Dietary Supplement: Enriched pomegranate juice

Placebo beverage

PLACEBO COMPARATOR

Participants will consume 200 ml of placebo drink concomitantly with 109 g of white bread

Dietary Supplement: Placebo beverage

Interventions

Enriched pomegranate juice DIETARY_SUPPLEMENT

Pure pomegranate juice enriched with grape seed and apple peel extract (200 ml) to be consumed with 109 g of bread

Enriched pomegranate juice

Placebo beverage DIETARY_SUPPLEMENT

Beverage containing the same type and amount of carbohydrates as pomegranate juice and similar flavor (200 ml) to be consumed with 109 g of bread

Placebo beverage

Eligibility Criteria

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

You may qualify if:

• Fasting glucose ≤ 5.6 mM;
• Body mass index (BMI) ≤ 30;
• Max glucose after the consumption of app. 109g of white bread less than about 8-9 mM (which is typical for the subjects we have measured previously);

You may not qualify if:

• Smoking;
• Participating in another trial that requires blood collection;
• Diagnosed with any chronic illness (including diabetes, hypertension etc.);
• On long term prescribed medication (except contraceptives);
• Pregnant or lactating;
• On a special diet or dietary regimen (for weight management or if regularly consuming fruit extract supplements);
• Allergy to fruits vegetables or pollen.

Sponsors & Collaborators

• University of Leeds: lead

Study Sites (1)

School of Food Science and Nutrition, University of Leeds

Leeds, West Yorkshire, LS2 9JT, United Kingdom

RECRUITING

MeSH Terms

Conditions

Hyperglycemia

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Gary Williamson, PhD

  University of Leeds

  STUDY CHAIR

• Aleksandra Konic Ristic, PhD

  University of Leeds

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gary Williamson, PhD

CONTACT

+441133438380; G.Williamson@leeds.ac.uk

Aleksandra Konic Ristic, PhD

CONTACT

+441133432979; A.KonicRistic@leeds.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Gary Williamson

Study Record Dates

• First Submitted: August 17, 2017
• First Posted: August 21, 2017
• Study Start: April 10, 2017
• Primary Completion: August 20, 2018
• Study Completion: September 1, 2018
• Last Updated: June 28, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will share

Locations

GB (1)