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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04867655
Other study ID # Glasgow University
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date July 10, 2019
Est. completion date May 4, 2022

Study information

Verified date October 2021
Source University of Glasgow
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 16
Est. completion date May 4, 2022
Est. primary completion date May 4, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 50 Years
Eligibility 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)

Study Design


Related Conditions & MeSH terms


Intervention

Other:
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 ß-Glucan
Approximately 500 ml of orange juice mixed with either 6g or 3 g of ß-Glucan will be consumed and then blood and urine samples will be collected for 24 hours

Locations

Country Name City State
United Kingdom Human Nutrition, College of Medicine, Veterinary and Life Science Glasgow

Sponsors (1)

Lead Sponsor Collaborator
University of Glasgow

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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 Body weight Difference in body weight in kilograms between two experimental trials measured by TANITA scales (TBF-300, Cranela, UK). 7 days
Secondary Body fatness Difference in percentage of body fat between two experimental trials measured by TANITA scales (TBF-300, Cranela, UK). 7 days
Secondary Dietary Intake Difference in energy/macronutrient intake prior to and during the experimental trails measured from weighted food records 3 days and 24 hours
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