Acute Effect of Orange Juice Mixed With Oat β-Glucan on Bioavailability of Polyphenols in Healthy Individuals
1 other identifier
interventional
16
1 country
1
Brief Summary
Brief summary Orange juice is the most widely consumed fruit juice, accounting for around a third of the total fruit juice market and is a rich source of vitamin C and bioactive compounds, predominantly flavonoids. Current research into the health effects of fruit juice consumption has presented some conflicting conclusions. Although potential health benefits have been attributed to the anti-inflammatory and anti-oxidant properties of the bioactive components in juice, other studies have suggested that the benefits of consuming orange are outweighed by the negative implications of the high sugar content leading to increases in blood glucose and insulin. At the same time it is well established that supplementation with a mean dose of 5g of β-Glucan, a soluble fibre derived from cereals such as oats or barley, significantly reduces insulin and glucose in healthy subjects and metabolic compromised individuals. Thus, the formulation of an OJ beverage with an added β-Glucan supplement may be a useful strategy to attenuate the detrimental impact of high sugar content. However, while delaying the absorption of glucose brings about favourable effects on post-prandial glycemia, dietary fibre may also reduce the bioavailability of some beneficial compounds, including polyphenols. So far, it remains unclear how addition of β-Glucan impacts bioavailability of orange juice flavanones. Thus, this study aims to determine how the bioavailability of orange juice polyphenols of healthy adults is affected mixing orange juice with 3 g and 6 g of oat β-Glucan.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable healthy
Started Jul 2019
Longer than P75 for not_applicable healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 10, 2019
CompletedFirst Submitted
Initial submission to the registry
April 27, 2021
CompletedFirst Posted
Study publicly available on registry
April 30, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 4, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
May 4, 2022
CompletedNovember 2, 2021
October 1, 2021
2.8 years
April 27, 2021
October 31, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Plasma pharmacokinetics of naringenin, hesperetin, eriodictyol, isorhamnetin and phenolic acid metabolites including phenylpropionic acids, phenylacetic acid and benzoic acid derivatives
Change in plasma concentrations collected at base line (0 hours) and 0.5,1, 2, 3,4,5,6,7,8, and 24 hours after ingestion of orange juice
24 hours
Urinary excretion of naringenin, hesperetin, eriodictyol, isorhamnetin and phenolic acid metabolites including phenylpropionic acids, phenylacetic acid and benzoic acid derivatives
Change in concentrations in urinary fraction collected at base line (0 hours) and after ingestion of orange juice (0-5, 5-8, 8-10, 10-24 hours)
24 hours
Secondary Outcomes (3)
Body weight
7 days
Body fatness
7 days
Dietary Intake
3 days and 24 hours
Study Arms (2)
Orange juice only
EXPERIMENTALExperimental test for 24 hours after consumption of orange juice only (Tropicana 'with bits').
Orange Juice mixed with either 6g or 3 g of β-Glucan
EXPERIMENTALExperimental test for 24 hours after consumption of orange juice (Tropicana 'with bits') with either 6g or 3 g of β-Glucan.
Interventions
Approximately 500 ml of orange juice will be consumed and then blood and urine samples will be collected for 24 hours
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
You may qualify if:
- healthy
- BMI (20 kg/m2-35 kg/m2)
- non-smoker
- not taking any drug therapies
- normal dietary habits
You may not qualify if:
- history of gastrointestinal diseases
- following a special diet
- take vitamin supplements, prebiotics, probiotics
- vegetarian
- engaged in strenuous exercise training
- heavy alcohol consumer
- pregnant or breastfeeding (females)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Human Nutrition, College of Medicine, Veterinary and Life Science
Glasgow, G31 2ER, United Kingdom
Related Publications (1)
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.
PMID: 36764628DERIVED
Study Officials
- STUDY CHAIR
Dale Malkova, PhD
University of Glasgow
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Senior Lecturer
Study Record Dates
First Submitted
April 27, 2021
First Posted
April 30, 2021
Study Start
July 10, 2019
Primary Completion
May 4, 2022
Study Completion
May 4, 2022
Last Updated
November 2, 2021
Record last verified: 2021-10