At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Role of the Fruit Matrix on the Absorption of Glucose From Orange Juice in Humans
In Brief
A clinical study evaluating 100% Orange juice, 50% Orange juice, and 4 other interventions for Healthy Nutrition. Completed, enrolled 25 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
250 mL of commercial 100% orange juice containing 25 g of total sugars (glucose, fructose, saccharose).
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
250 mL of water plus added sugars to attain the same concentration and composition of sugars (glucose, fructose, saccharose) as the 100% orange juice
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
Repetition of the 100% orange juice intervention
Repetition of the 0% orange juice intervention