Influence of the Fruit Matrix on Glucose and Insulin Responses After the Intake of Orange Juice in Healthy Human Males

Summary

QUALIFICATION: Role of the fruit matrix in glucose absorption from orange juice in healthy human volunteers.

MAIN OBJECTIVE:

Added sugars may have different effects on glycemic response than natural sugars present in fruit juice. The juice matrix (fiber, polyphenols, citric acid, vitamins, minerals) may positively influence this glycemic response. The main objective of this project is to investigate how, for the same qualitative and quantitative sugar composition, the variation in the percentage of fruit matrix present in the juice may affect the glycemic response in healthy male participants.

CLINICAL STUDY:

This is a randomized, double-blind, dose-response, crossover study in healthy male adult participants (18-45 years, 18.5-29.9 kg/m2, N=30). The participants will repeat the entire study (duplicate results) to address interindividual variability and increase the reliability of the results. Participants who agree to take part in the study will complete a series of validated questionnaires about their lifestyle habits. The company AMC Natural Drinks (Murcia, Spain) will prepare the following juices: 100% orange juice versus 50% orange juice and 0% orange juice (same sugar composition as 100% juice but with reduced or absent matrix, respectively). The drinks will be fully characterized in their composition.

The day before each trial, participants will complete a food diary to verify compliance with a polyphenol-free diet and estimate the amount of nutrients consumed (carbohydrates, fiber, water). They will arrive at the UCAM laboratory on an empty stomach where they will drink each of the juices on separate dates. The researchers will measure glycemic response by vein cannulation at baseline (0 min, baseline) and after the consumption of the drinks (time points: 15, 30, 45, 60, 90 and 120 minutes). Results will be compared with the response to a single oral dose of glucose (glycemic index). The participants will repeat some of the test drinks (total: 6 interventions at least 2 or 3 days apart). The researchers will also measure insulin (at the same time points after drinking the test drinks) and analyze the differences in the effects on glycemic and insulin responses between the three types of juices using appropriate statistical analysis.

Conditions

• Healthy Nutrition

Interventions

OTHER

50% Orange juice

250 mL of 50% diluted orange juice (100% orange juice) plus added sugars to attain the same concentration and composition of sugars (glucose, fructose, saccharose) as the 100% orange juice

OTHER

0% Orange juice

250 mL of water plus added sugars to attain the same concentration and composition of sugars (glucose, fructose, saccharose) as the 100% orange juice

OTHER

Glucose

250 mL of water with 25 g of glucose. To determine the glycemic index of the different drinks and to characterize the glucose and insuline response of the participants

OTHER

100% Orange juice Rep

Repetition of the 100% orange juice intervention

OTHER

0% Orange juice Rep

Repetition of the 0% orange juice intervention

OTHER

100% Orange juice

250 mL of commercial 100% orange juice containing 25 g of total sugars (glucose, fructose, saccharose).

Sponsors & Collaborators

• Universidad Católica San Antonio de Murcia

  collaborator OTHER

• María-Teresa García-Conesa

  lead OTHER_GOV

Principal Investigators

• Francisco-Tomás G Barberán, PhD · CEBAS-CSIC

Study Design

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

SINGLE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Max Age

45 Years

Sex

MALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2024-10-21

Primary Completion

2024-12-20

Completion

2025-01-31

Countries

• Spain

Study Locations