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

NCT ID: NCT03255876

Last Updated: 2018-06-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-04-10
• Study Completion Date: 2018-09-01

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.

Detailed Description

Consumption of carbohydrate-rich foods or sugary drinks affects blood glucose levels. Results from a large number of studies in humans have shown that diets rich in foods that give lower glucose response beneficially affect elevated fasting blood glucose and insulin levels, increase the sensitivity to insulin, contribute to the reduction of body weight and lipids levels and ultimately bring lower risk of type 2 diabetes.

Blood glucose responses depend on the amount and type of carbohydrate(s) present in the meal. Difference in post-prandial blood glucose response to different types of carbohydrates is mainly due to the different rate of their digestion. However, response to the same carbohydrate-rich food can be different between different individuals. Blood glucose levels after carbohydrate-rich meal are shown to be significantly higher in subjects on high-fat diet, in overweight or obese people, or in subjects with different levels of digestive enzymes.

Results from in vitro studies indicate the potential of polyphenols, naturally found in fruits, vegetables and grains, to attenuate post-prandial blood glucose spikes following a carbohydrate-rich meal. It was previously shown that different polyphenols can slow down carbohydrate digestion through partial inhibition of the main enzymes involved, can decrease glucose and fructose transport from the gut after digestion and can improve the action of insulin after glucose reaches the bloodstream.

In the previous study it was shown that pomegranate juice attenuates the increase in blood glucose levels after a starchy meal. This effect is, at least partly, the result of hindered starch digestion by polyphenols present in pomegranate juice.

The present study will 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 or determined by the individual levels of digestive enzymes.

Healthy volunteers will be asked to consume two different meals: (1) white bread with pomegranate juice enriched with extracts from grape seeds and apple peels or (2) white bread with placebo drink with the same type and amount of carbohydrates and similar flavor as enriched pomegranate juice, but without polyphenols.

The levels of glucose, insulin, gastric inhibitory polypeptide (GIP) and glucagon like peptide-1 (GLP-1) will be measured in plasma isolated from blood samples obtained before and up to 3 hours after the consumption of each meal. The levels of triglycerides and relevant organic and fatty acids will also be determined.

Before recruitment volunteers will be screened for eligibility based on glucose levels, BMI and glycemic response to white bread. Additional measurements taken at the screening will include blood pressure values and blood lipids levels. All participants will be characterized for the activity of salivary a-amylase and copies of a-amylase gene (AMY1).

Conditions

Hyperglycemia, Postprandial; Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Enriched pomegranate juice

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

Group Type: EXPERIMENTAL

Enriched pomegranate juice

Intervention Type: DIETARY_SUPPLEMENT

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

Placebo beverage

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

Group Type: PLACEBO_COMPARATOR

Placebo beverage

Intervention Type: 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

Interventions

Enriched pomegranate juice

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

Intervention Type: DIETARY_SUPPLEMENT

Placebo beverage

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

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• 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);

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Leeds

OTHER

Sponsor Role: lead

Responsible Party

Gary Williamson

Professor Gary Williamson

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gary Williamson, PhD

Role: STUDY_CHAIR

University of Leeds

Aleksandra Konic Ristic, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Leeds

Locations

School of Food Science and Nutrition, University of Leeds

Leeds, West Yorkshire, United Kingdom

Site Status: RECRUITING

Countries

United Kingdom

Central Contacts

Gary Williamson, PhD

Role: CONTACT

G.Williamson@leeds.ac.uk

+441133438380

Aleksandra Konic Ristic, PhD

Role: CONTACT

A.KonicRistic@leeds.ac.uk

+441133432979

Facility Contacts

Gary Williamson, PhD

Role: primary

G.Williamson@leeds.ac.uk

+441133438380

Aleksandra Konic Ristic, PhD

Role: backup

a.konicristic@leeds.ac.uk

+441133432979

Other Identifiers

MEEC 16-011

Identifier Type: -

Identifier Source: org_study_id