HealthyNCT04867655
Acute Effect of Orange Juice Mixed With Oat β-Glucan on Bioavailability of Polyphenols in Healthy Individuals
A study testing Orange Juice and Orange juice with either 6g or 3 g of β-Glucan in people with Healthy, run by University of Glasgow at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Orange Juice and Orange juice with either 6g or 3 g of β-Glucan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 10 Jul 2019to 4 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy
- BMI (20 kg/m2-35 kg/m2)
- non-smoker
- not taking any drug therapies
- normal dietary habits
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Human Nutrition, College of Medicine, Veterinary and Life Science
Glasgow, G31 2ER
About this study
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.
Read the 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.
- Conditions
- Healthy
- Being tested
- Orange Juice, Orange juice with either 6g or 3 g of β-Glucan
- Keywords
- Flavanones, β-Glucan, Orange Juice, Biological Availability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Orange JuiceOther
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-GlucanOther
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
| Study group | Role | What they receive |
|---|---|---|
| Orange juice only | Experimental | Experimental test for 24 hours after consumption of orange juice only (Tropicana 'with bits'). Receives: 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. Receives: Other: Orange juice with either 6g or 3 g of β-Glucan |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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)
Measured: 24 hours
Secondary outcomes (3)
Body weight
Difference in body weight in kilograms between two experimental trials measured by TANITA scales (TBF-300, Cranela, UK).
Measured: 7 days
Body fatness
Difference in percentage of body fat between two experimental trials measured by TANITA scales (TBF-300, Cranela, UK).
Measured: 7 days
Dietary Intake
Difference in energy/macronutrient intake prior to and during the experimental trails measured from weighted food records
Measured: 3 days and 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2021
- Study start10 Jul 2019
- Primary completion4 May 2022 (estimated)
- Study completion4 May 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Glasgow
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Dalia Malkova, University of Glasgow
- Investigators
- Dale Malkova, PhD, Study chair, University of Glasgow
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04867655
- Sponsor's protocol ID
- Glasgow University
- Status last verified
- Oct 2021
- First submitted
- 27 Apr 2021
- Last updated
- 2 Nov 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 36764628
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Effect of Orange Juice Mixed With Oat β-Glucan on Bioavailability of Polyphenols in Healthy Individuals
- ClinicalTrials.gov ID
- NCT04867655
- Acronym / sponsor ID
- Glasgow University
- Conditions
- Healthy
- Keywords
- Flavanones, β-Glucan, Orange Juice, Biological Availability
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- University of GlasgowUniversity, hospital or other
- Study start
- 10 Jul 2019 (actual)
- Primary completion
- 4 May 2022 (estimated)
- Study completion
- 4 May 2022 (estimated)
- First posted
- 30 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Orange juice only | Experimental | Other: Orange JuiceExperimental 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 | Experimental | Other: Orange juice with either 6g or 3 g of β-GlucanExperimental test for 24 hours after consumption of orange juice (Tropicana 'with bits') with either 6g or 3 g of β-Glucan. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- healthy
- BMI (20 kg/m2-35 kg/m2)
- non-smoker
- not taking any drug therapies
- normal dietary habits
Key exclusion criteria (7 listed)
- history of gastrointestinal diseases
- following a special diet
- take vitamin supplements, prebiotics, probiotics
- vegetarian
- engaged in strenuous exercise training
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Orange JuiceApproximately 500 ml of orange juice will be consumed and then blood and urine samples will be collected for 24 hours | Other | Orange juice only |
| Orange juice with either 6g or 3 g of β-GlucanApproximately 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 | Other | Orange Juice mixed with either 6g or 3 g of β-Glucan |
Primary outcome
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
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)
3 secondary outcomes
Body weight
Time frame: 7 days
Body fatness
Time frame: 7 days
Dietary Intake
Time frame: 3 days and 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2021.
- Derived from this study: PubMed 36764628Pereira-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dale Malkova, PhD study chair
University of Glasgow
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Orange Juice and Orange juice with either 6g or 3 g of β-Glucan in people with Healthy, run by University of Glasgow at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma pharmacokinetics of naringenin, hesperetin, eriodictyol, isorhamnetin and phenolic acid metabolites including phenylpropionic acids, phenylacetic acid and benzoic acid derivatives (time frame: 24 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04867655, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2021.