Acute Effect of Orange Juice Mixed With Oat β-Glucan on Bioavailability of Polyphenols in Healthy Individuals

• ClinicalTrials.gov Identifier: NCT04867655
• Recruitment Status: Active, not recruiting
• First Posted: April 30, 2021
• Last Update Posted: November 2, 2021
• Sponsor: University of Glasgow
• Information provided by (Responsible Party): Dr Dalia Malkova, University of Glasgow

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Healthy	Other: Orange Juice; Other: Orange juice with either 6g or 3 g of β-Glucan	Not Applicable

Detailed Description:

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.

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 16 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Acute Effect of Orange Juice Mixed With Oat β-Glucan on Bioavailability of Polyphenols in Healthy Individuals
• Actual Study Start Date: July 10, 2019
• Estimated Primary Completion Date: May 4, 2022
• Estimated Study Completion Date: May 4, 2022

Arms and Interventions

Arm	Intervention/treatment
Experimental: Orange juice only; Experimental test for 24 hours after consumption of orange juice only (Tropicana 'with bits').	Other: Orange Juice; Approximately 500 ml of orange juice will be consumed and then blood and urine samples will be collected for 24 hours
Experimental: 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.	Other: 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

Outcome Measures

Primary Outcome Measures :

1. Plasma pharmacokinetics of naringenin, hesperetin, eriodictyol, isorhamnetin and phenolic acid metabolites including phenylpropionic acids, phenylacetic acid and benzoic acid derivatives [ Time Frame: 24 hours ]
   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
2. Urinary excretion of naringenin, hesperetin, eriodictyol, isorhamnetin and phenolic acid metabolites including phenylpropionic acids, phenylacetic acid and benzoic acid derivatives [ Time Frame: 24 hours ]
   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)

Secondary Outcome Measures :

1. Body weight [ Time Frame: 7 days ]
   Difference in body weight in kilograms between two experimental trials measured by TANITA scales (TBF-300, Cranela, UK).
2. Body fatness [ Time Frame: 7 days ]
   Difference in percentage of body fat between two experimental trials measured by TANITA scales (TBF-300, Cranela, UK).
3. Dietary Intake [ Time Frame: 3 days and 24 hours ]
   Difference in energy/macronutrient intake prior to and during the experimental trails measured from weighted food records

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 50 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

• healthy
• BMI (20 kg/m2-35 kg/m2)
• non-smoker
• not taking any drug therapies
• normal dietary habits

Exclusion Criteria:

• 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)

Contacts and Locations

Locations

United Kingdom

Human Nutrition, College of Medicine, Veterinary and Life Science

Glasgow, United Kingdom, G31 2ER

Sponsors and Collaborators

University of Glasgow

Investigators

• Study Chair: Dale Malkova, PhD; University of Glasgow

More Information

• Responsible Party: Dr Dalia Malkova, Senior Lecturer, University of Glasgow
• ClinicalTrials.gov Identifier: NCT04867655
• Other Study ID Numbers: Glasgow University
• First Posted: April 30, 2021
• Last Update Posted: November 2, 2021
• Last Verified: October 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Dr Dalia Malkova, University of Glasgow:

Flavanones; β-Glucan; Orange Juice; Biological Availability