Acute Effect of Orange Juice Mixed With Oat β-Glucan on Bioavailability of Polyphenols in Healthy Individuals
NCT ID: NCT04867655
Last Updated: 2021-11-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
16 participants
INTERVENTIONAL
2019-07-10
2022-05-04
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Eligible participants for this study will be healthy adults aged 18 - 50 years and with a BMI in the normal or overweight to obese range (≥20 kg/m2). Participants will be required to be non-smokers, with a stable weight for the previous 3 months, and not engage in regular strenuous physical activity. Other exclusion criteria will include suffering from any chronic disease, taking any medication, or following a special diet, including being vegetarian and vegan. Before being enrolled in the study, potential participants will attend a health screening session, in which they will complete a health screening and physical activity questionnaire
This study will be a randomised controlled cross-over trial in which each participant will complete two 24-h feeding trials. The experimental trials will be separated by a wash out period of at least 7 days. The order of trials will be randomised for each participant, using a random sequence generator. In the morning of the experimental trial participants will consumed approximately 500ml of OJ (Tropicana 'with bits') without or with Oatwell fibre supplement, providing either 6g or 3 g of β-Glucan. Blood samples and urinary fractions will be collected prior to (baseline) and for 24 hours after consumption of corresponding beverage. Participants will be asked to follow a special polyphenol-free diet and record weighted dietary intake for 2 days preceding each trial and during the day of the experimental trial.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
OTHER
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Orange juice only
Experimental test for 24 hours after consumption of orange juice only (Tropicana 'with bits').
Orange Juice
Approximately 500 ml of orange juice will be consumed and then blood and urine samples will be collected for 24 hours
Orange Juice mixed with either 6g or 3 g of β-Glucan
Experimental test for 24 hours after consumption of orange juice (Tropicana 'with bits') with either 6g or 3 g of β-Glucan.
Orange juice with either 6g or 3 g of β-Glucan
Approximately 500 ml of orange juice mixed with either 6g or 3 g of β-Glucan will be consumed and then blood and urine samples will be collected for 24 hours
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Orange Juice
Approximately 500 ml of orange juice will be consumed and then blood and urine samples will be collected for 24 hours
Orange juice with either 6g or 3 g of β-Glucan
Approximately 500 ml of orange juice mixed with either 6g or 3 g of β-Glucan will be consumed and then blood and urine samples will be collected for 24 hours
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* BMI (20 kg/m2-35 kg/m2)
* non-smoker
* not taking any drug therapies
* normal dietary habits
Exclusion Criteria
* following a special diet
* take vitamin supplements, prebiotics, probiotics
* vegetarian
* engaged in strenuous exercise training
* heavy alcohol consumer
* pregnant or breastfeeding (females)
18 Years
50 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Glasgow
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Dr Dalia Malkova
Senior Lecturer
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Dale Malkova, PhD
Role: STUDY_CHAIR
University of Glasgow
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Human Nutrition, College of Medicine, Veterinary and Life Science
Glasgow, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Pereira-Caro G, Almutairi TM, Caceres-Jimenez S, Moreno-Rojas JM, Malkova D, Garcia AL, Crozier A. Bioavailability of orange juice (poly)phenols: beta-glucan-rich oat bran decreases urinary excretion of flavanone phase II metabolites and enhances excretion of microbiota-derived phenolic catabolites. Free Radic Biol Med. 2023 Apr;199:34-43. doi: 10.1016/j.freeradbiomed.2023.02.002. Epub 2023 Feb 9.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Glasgow University
Identifier Type: -
Identifier Source: org_study_id