New Insights Into the Biological Activity Evaluation of Mango Juices Processed by Sustainable Emerging Technologies

NCT07068854 | Not Yet Recruiting

• 1 other identifier: PID2023-147025NB-I00
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this clinical trial is to study the effect of a habitual dietary intake of commercial high pressure-processed (HPP) mango juice \[mango puree (20%)-orange juice (80%)\] or control juice \[water (20%)-HPP orange juice (80%)\]. There are numerous in vitro and in vivo animal studies that support exceptional health-promoting characteristics of mango products (pulp, peel, seed, juice, extracts, etc.) such as antidiabetic, anticancer, antiinflammatory, antioxidant and antibacterial activities based on their phytochemical composition, but there are many fewer studies assessing the absorption, metabolism, and health-related properties of phytochemical from commercial mango fruit juices (only 20% of mango pulp) in humans. Consequently, this study proposes for the first time the study of the effects of commercial HPP mango juice consumption on health biomarkers by a human intervention study. Researchers will compare the bioavailability (metabolite profiles) of compounds with health effects and the biomarkers of health to evaluate if mango juice works better that control juice.

Conditions

Biomarkers of Food Intake in Healthy Subjects

Keywords

Mango juice; Phytochemicals; Bioavailability; Biomarkers; Health

Outcome Measures

Primary Outcomes (1)

• C-Reactive Protein (CRP)

  Changes of plasma CRP levels as result of HPP mango juice intake

  At Week 0 (day 0-Baseline), and Weeks 2 (day 14), and 4 (day 28)

Secondary Outcomes (25)

• BMI

  At Week 0 (day 0-Baseline), and Weeks 2 (day 14), and 4 (day 28)

• Body weight

  At Week 0 (day 0-Baseline), and Weeks 2 (day 14), and 4 (day 28)

• Pulse

  At Week 0 (day 0-Baseline), and Weeks 2 (day 14), and 4 (day 28)

• Temperature

  At Week 0 (day 0-Baseline), and Weeks 2 (day 14), and 4 (day 28)

• Systolic blood pressure

  At Week 0 (day 0-Baseline), and Weeks 2 (day 14), and 4 (day 28)

Study Arms (2)

HPP mango juice

EXPERIMENTAL

mango puree (20%)-orange juice (80%)

Other: HPP mango juice group

control juice

EXPERIMENTAL

water (20%)-HPP orange juice (80%)

Other: control juice

Interventions

HPP mango juice group OTHER

During each intervention period, participants will be instructed to consume 500 mL of juice/day in two doses, 250 mL in the morning and 250 mL in the afternoon

HPP mango juice

control juice OTHER

During each intervention period, participants will be instructed to consume 500 mL of juice/day in two doses, 250 mL in the morning and 250 mL in the afternoon

control juice

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Body mass index \[BMI\] 25-29.9 kg/m\^2
• Age 18-50 years
• Plasma total cholesterol levels 180-235 mg/dL
• Plasma retinol concentration in the upper tertile of the normal reference range (20-60 µg/dL)

You may not qualify if:

• Use of medication/food supplements to lower blood cholesterol
• Chronic disease, such as high blood pressure, diabetes, and heart disease
• Pregnancy or lactation
• Smoking habits
• Alcohol consumption above recommendations
• Allergy to mango or orange fruit

Sponsors & Collaborators

• National Research Council, Spain: lead

Study Sites (1)

Institute of Food Science, Technology and Nutrition (ICTAN), National Research Council (CSIC)

Madrid, Madrid, 28040, Spain

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: June 24, 2025
• First Posted: July 16, 2025
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: July 16, 2025

Record last verified: 2025-07

Locations

ES (1)