NCT04867655

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

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
16

participants targeted

Target at below P25 for not_applicable healthy

Timeline
Completed

Started Jul 2019

Longer than P75 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 10, 2019

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

April 27, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 30, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 4, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 4, 2022

Completed
Last Updated

November 2, 2021

Status Verified

October 1, 2021

Enrollment Period

2.8 years

First QC Date

April 27, 2021

Last Update Submit

October 31, 2021

Conditions

Keywords

Flavanonesβ-GlucanOrange JuiceBiological Availability

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

EXPERIMENTAL

Experimental test for 24 hours after consumption of orange juice only (Tropicana 'with bits').

Other: Orange Juice

Orange Juice mixed with either 6g or 3 g of β-Glucan

EXPERIMENTAL

Experimental test for 24 hours after consumption of orange juice (Tropicana 'with bits') with either 6g or 3 g of β-Glucan.

Other: Orange juice 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

Orange juice only

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

Orange Juice mixed with either 6g or 3 g of β-Glucan

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

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

Location

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.

Study Officials

  • Dale Malkova, PhD

    University of Glasgow

    STUDY CHAIR

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

Locations