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

NCT06638190 | Completed

• 1 other identifier: CE092408
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Orange juice; Sugar composition; Fruit matrix; Adult males; Glucose response; Insuline response; Lifestyle habits

Outcome Measures

Primary Outcomes (1)

• Incremental Area Under the Curve (iAUC) of blood glucose over 120 minutes.

  Blood glucose samples collected via vein cannulation. Glucose measured using a Glucose Oxidase (GOD) Activity Assay Kit (E-BC-K520-M) (Elabscience, Texas, USA).

  0 minutes, 15 minutes, 30 minutes, 45 minutes, 60 minutes, 90 minutes and 120 minutes following the consumption of each drink.

Secondary Outcomes (7)

• Peak Blood Glucose Concentration

  0 minutes, 15 minutes, 30 minutes, 45 minutes, 60 minutes, 90 minutes and 120 minutes following the consumption of each drink.

• Blood Glucose Concentration at 15 Minutes

  0 minutes, 15 minutes, 30 minutes, 45 minutes, 60 minutes, 90 minutes and 120 minutes following the consumption of each drink.

• Time to peak concentration for glucose

  0 minutes, 15 minutes, 30 minutes, 45 minutes, 60 minutes, 90 minutes and 120 minutes following the consumption of each drink.

• Incremental Area Under the Curve (iAUC) of blood insulin over 120 minutes.

  0 minutes, 15 minutes, 30 minutes, 45 minutes, 60 minutes, 90 minutes and 120 minutes following the consumption of each drink.

• Peak Blood Insulin Concentration

  0 minutes, 15 minutes, 30 minutes, 45 minutes, 60 minutes, 90 minutes and 120 minutes following the consumption of each drink.

Other Outcomes (8)

• Dietary habits

  1st visit to the study laboratory after passing the telephone interview and before starting the intervention.

• Physical Activity

  1st visit to the study laboratory after passing the telephone interview and before starting the intervention.

• Sleep Quality

  1st visit to the study laboratory after passing the telephone interview and before starting the intervention.

Study Arms (6)

100% Orange juice

ACTIVE COMPARATOR

In this arm, the participants will drink a total of 250 mL of a commercial 100% orange juice with known total sugar content (25 g) and matrix composition.

Other: 100% Orange juice

50% Orange juice

EXPERIMENTAL

In this arm, the participants will drink 250 mL of a beverage containing 50% of the same commercial orange juice (active comparator) with added sugars to match the content of sugars the 100% juice. The content of matrix will be 50% of the active comparator.

Other: 50% Orange juice

0% Orange juice

EXPERIMENTAL

In this arm, the participants will drink 250 mL of 100% water with added sugars to match the content of sugars of the commercial 100% orange juice (active comparator). This drink will not contain the food matrix components.

Other: 0% Orange juice

Glucose solution

ACTIVE COMPARATOR

In this arm, the participants will drink 250 mL of a glucose solution with a total 25 g of glucose (to match the total concentration of sugars in the test beverages). This arm will allow for the measurement of the glycemic indexes of the test drinks. In addition, it will allow for a characterization of the participant (basal glucose level at the start of the intervention and type of responder, e.g. biphasic, monophasic).

Other: Glucose

100% Orange juice Rep

ACTIVE COMPARATOR

This arm will be a repetition of the 100% Orange juice arm

Other: 100% Orange juice Rep

0% Orage juice Rep

EXPERIMENTAL

Thia arm will be a repetition of the 0% Prange juice arm

Other: 0% Orange juice Rep

Interventions

100% Orange juice OTHER

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

100% Orange juice

50% Orange juice OTHER

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

50% Orange juice

0% Orange juice OTHER

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

0% Orange juice

Glucose OTHER

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

Glucose solution

100% Orange juice Rep OTHER

Repetition of the 100% orange juice intervention

100% Orange juice Rep

0% Orange juice Rep OTHER

Repetition of the 0% orange juice intervention

0% Orage juice Rep

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• BMI between 18.5 and 29.9 kg/m2
• To be habitual breakfast consumers
• To be willing to consume the study beverages

You may not qualify if:

• To be on a diet
• To have food allergies
• To have some kind of sensitiviness or aversion to beverages in this study
• To have had significant weight fluctuations within the past 6 months
• Previous diagnosis of diabetes or pre-diabetes
• Previous diagnosis of other gastrointestinal disease
• Previous diagnosis of liver disease
• Previous diagnosis of kidney disease
• Previous diagnosis of a metabolic disorder

Sponsors & Collaborators

• María-Teresa García-Conesa: lead
• Universidad Católica San Antonio de Murcia: collaborator

Study Sites (1)

Universidad Catolica de San Antonio (UCAM)

Murcia, Murcia, 30107, Spain

Location

Related Publications (14)

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MeSH Terms

Interventions

Glucose

Intervention Hierarchy (Ancestors)

Hexoses; Monosaccharides; Sugars; Carbohydrates

Study Officials

• Francisco-Tomás G Barberán, PhD

  CEBAS-CSIC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Test beverages will be served cold in plastic bottles with lids.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Senior Researcher

Model Details: Participants will complete four tests at least 2-3 day apart. They will arrive at the laboratory at 8:00 am following a 10-12 h fast, except for a small amount of water permitted up to 1 h before arriving. Foods rich in polyphenols (particularly citrus fruits) will be forbidden on the day before the studies. On the day before to each test session, the participants will complete a food diary to verify adherence to the polyphenol-free diet and fasting protocol and to estimate the amount of nutrients consumed (carbohydrates, fibre, water). The sequence of beverages intake will be randomized. Participants will consume one of the three beverages, including (1) 100% orange juice (AMC Murcia, Spain), (2) orange beverage with 50% orange juice and 50% water with added sugars to match the content of the 100% juice, and (3) 100% water with added sugars to match the content of the 100% juice. The study will be repeated to evaluate intra and inter-individual variability.

Study Record Dates

• First Submitted: October 7, 2024
• First Posted: October 15, 2024
• Study Start: October 21, 2024
• Primary Completion: December 20, 2024
• Study Completion: January 31, 2025
• Last Updated: November 28, 2025

Record last verified: 2025-11

Locations

ES (1)