Diabetes Mellitus, Type 2NCT04412798
Orange Juice and Glycaemic Control in Type 2 Diabetes Mellitus
A study testing orange juice concentrate, Sugar-sweetened orange-flavoured beverage and Whole orange juice with skin removed in people with Diabetes Mellitus, Type 2, run by Hasselt University at 1 site in Belgium.
Trial summary
The evidence on the consumption of 100% orange juice in people with type 2 diabetes is highly variable and largely out-of-date, with a few studies reporting acute negative glycaemic effects when 100% orange juice is drunk with or without a meal. Read more about this study
- Who is it for?
- Ages 25 to 75 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- orange juice concentrate, Sugar-sweetened orange-flavoured beverage and Whole orange juice with skin removed
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteBelgium
- Study dates
- 1 May 2020to 1 Apr 2024
- 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 25 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Inclusion Criteria: individuals (aged 25-75 years) with up to 8 years of T2DM, according to ADA criteria (Two-hour plasma glucose ≥200 mg/dL (11.1 mmol/L) during OGTT. The test should be performed as described by the WHO, using a glucose load containing the equivalent of 75-g anhydrous glucose dissolved in water; or HbA1c > ≥6.5% (48 mmol/mol)).
Who cannot join
- pregnancy,
- participants on exogenous insulin therapy,
- HbA1c >8.5%,
- BMI <22 or >35 kg/m²,
- regular smokers (>1 cigarette per day),
- participants with established cardiovascular disease,
Show all 10Show fewer
- neurological disease,
- cancer,
- renal disease.
- Participants who are unwilling to consume any of the standard foods/drinks
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Orange Juice During Breakfast on Glycaemic Control in Individuals With Type 2 Diabetes Mellitus
The evidence on the consumption of 100% orange juice in people with type 2 diabetes is highly variable and largely out-of-date, with a few studies reporting acute negative glycaemic effects when 100% orange juice is drunk with or without a meal. The aim of the project is to study the impact of the intake of a single serving of 100% orange juice on glycaemic control in male patients with pre-existing type 2 diabetes mellitus. In addition, immunological parameters and Alzheimer disease related biomarkers will be assessed to examine the chronic inflammatory state of these patients
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- orange juice concentrate, Sugar-sweetened orange-flavoured beverage, Whole orange juice with skin removed
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
orange juice concentrateOther
250mL of 100% orange juice made from concentrate
Sugar-sweetened orange-flavoured beverageOther
Sugar-sweetened orange-flavoured beverage, energy-matched to the orange juice condition
Whole orange juice with skin removedOther
Whole orange pieces with skin removed, energy-matched to the orange juice condition
| Study group | Role | What they receive |
|---|---|---|
| group 1 | Other | orange juice concentrate Receives: Other: orange juice concentrate |
| Group 2 | Other | Sugar-sweetened orange-flavoured beverage Receives: Other: Sugar-sweetened orange-flavoured beverage |
| Group 3 | Other | Whole orange juice with skin removed Receives: Other: Whole orange juice with skin removed |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycaemic responses venous blood
Venous blood samples collected to examine systemic glycemia (venous blood glucose concentration (mg/dL)) before, during and after a breakfast (differing in supplemented juice composition) for up to 5 hours postprandial.
Measured: baseline
Glycaemic responses venous blood
Venous blood samples collected to examine systemic glycemia (venous blood glucose concentration (mg/dL)) before, during and after a breakfast (differing in supplemented juice composition) for up to 5 hours postprandial.
Measured: Day 5
Glycaemic responses venous blood
Venous blood samples collected to examine systemic glycemia (venous blood glucose concentration (mg/dL)) before, during and after a breakfast (differing in supplemented juice composition) for up to 5 hours postprandial.
Measured: Day 10
Insulin responses
Venous blood samples collected to examine systemic insulinemia (venous blood insulin concentration (pmol/L)) before, during and after a breakfast (differing in supplemented juice composition) for up to 5 hours postprandial.
Measured: Baseline
Insulin responses
Venous blood samples collected to examine systemic insulinemia (venous blood insulin concentration (pmol/L)) before, during and after a breakfast (differing in supplemented juice composition) for up to 5 hours postprandial.
Measured: Day 5
Insulin responses
Venous blood samples collected to examine systemic insulinemia (venous blood insulin concentration (pmol/L)) before, during and after a breakfast (differing in supplemented juice composition) for up to 5 hours postprandial.
Measured: Day 10
Capillary glycaemic responses
Capillary blood samples collected to examine glycemia before, during and after a breakfast (differing in supplemented juice composition) for up to 5 hours postprandial.
Measured: Baseline
Capillary glycaemic responses
Capillary blood samples collected to examine glycemia before, during and after a breakfast (differing in supplemented juice composition) for up to 5 hours postprandial.
Measured: Day 5
Capillary glycaemic responses
Capillary blood samples collected to examine glycemia before, during and after a breakfast (differing in supplemented juice composition) for up to 5 hours postprandial.
Measured: Day 10
Secondary outcomes (6)
Glycated haemoglobin measure
Measured on a single blood sample to characterize patients' overall glycaemic contro
Measured: Baseline
Flow cytometry
Fasting venous blood samples collected to examine Peripheral blood mononuclear cells (flow cytometry) to measure immunological parameters
Measured: Baseline
Alzheimer disease related biomarkers
Blood samples will be collected every 30 min for 5 hours to examine Alzheimer disease relevant biomarkers (Abeta42, Abeta40, Tau, p-Tau, neuroinflammatory markers and other)
Measured: Baseline
BMI
body weight/height (to determine BMI)
Measured: Baseline
Waist/hip circumference (Body composition)
Waist/hip circumference
Measured: Baseline
Systolic/diastolic blood pressure
Systolic/diastolic blood pressure
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2020
- Study start1 May 2020
- Primary completion1 Apr 2024
- Study completion1 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hasselt University
- Sponsor type
- University, hospital or other
- Collaborators
- Hochschule Geisenheim University
- Responsible party
- Principal investigator, Dominique Hansen, Hasselt University
- Investigators
- Dominique Hansen, prof. dr., Principal investigator, Hasselt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04412798
- Sponsor's protocol ID
- Orange -Juice-001
- Status last verified
- May 2024
- First submitted
- 29 May 2020
- Last updated
- 17 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Orange Juice During Breakfast on Glycaemic Control in Individuals With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT04412798
- Acronym / sponsor ID
- Orange -Juice-001
- Conditions
- Diabetes Mellitus, Type 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Hasselt UniversityUniversity, hospital or other
- Collaborators
- Hochschule Geisenheim University
- Study start
- 1 May 2020 (actual)
- Primary completion
- 1 Apr 2024 (actual)
- Study completion
- 1 Apr 2024 (actual)
- First posted
- 2 Jun 2020 (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.
The evidence on the consumption of 100% orange juice in people with type 2 diabetes is highly variable and largely out-of-date, with a few studies reporting acute negative glycaemic effects when 100% orange juice is drunk with or without a meal. The aim of the project is to study the impact of the intake of a single serving of 100% orange juice on glycaemic control in male patients with pre-existing type 2 diabetes mellitus. In addition, immunological parameters and Alzheimer disease related biomarkers will be assessed to examine the chronic inflammatory state of these patients
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| group 1 | Other | Other: orange juice concentrateorange juice concentrate |
| Group 2 | Other | Other: Sugar-sweetened orange-flavoured beverageSugar-sweetened orange-flavoured beverage |
| Group 3 | Other | Other: Whole orange juice with skin removedWhole orange juice with skin removed |
Who may qualify
- Ages
- 25 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Inclusion Criteria: individuals (aged 25-75 years) with up to 8 years of T2DM, according to ADA criteria (Two-hour plasma glucose ≥200 mg/dL (11.1 mmol/L) during OGTT. The test should be performed as described by the WHO, using a glucose load containing the equivalent of 75-g anhydrous glucose dissolved in water; or HbA1c > ≥6.5% (48 mmol/mol)).
Key exclusion criteria (10 listed)
- pregnancy,
- participants on exogenous insulin therapy,
- HbA1c >8.5%,
- BMI <22 or >35 kg/m²,
- regular smokers (>1 cigarette per day),
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 juice concentrate250mL of 100% orange juice made from concentrate | Other | group 1 |
| Sugar-sweetened orange-flavoured beverageSugar-sweetened orange-flavoured beverage, energy-matched to the orange juice condition | Other | Group 2 |
| Whole orange juice with skin removedWhole orange pieces with skin removed, energy-matched to the orange juice condition | Other | Group 3 |
Primary outcome
Glycaemic responses venous blood
Time frame: baseline
Venous blood samples collected to examine systemic glycemia (venous blood glucose concentration (mg/dL)) before, during and after a breakfast (differing in supplemented juice composition) for up to 5 hours postprandial.
Glycaemic responses venous blood
Time frame: Day 5
Venous blood samples collected to examine systemic glycemia (venous blood glucose concentration (mg/dL)) before, during and after a breakfast (differing in supplemented juice composition) for up to 5 hours postprandial.
Glycaemic responses venous blood
Time frame: Day 10
Venous blood samples collected to examine systemic glycemia (venous blood glucose concentration (mg/dL)) before, during and after a breakfast (differing in supplemented juice composition) for up to 5 hours postprandial.
Insulin responses
Time frame: Baseline
Venous blood samples collected to examine systemic insulinemia (venous blood insulin concentration (pmol/L)) before, during and after a breakfast (differing in supplemented juice composition) for up to 5 hours postprandial.
Insulin responses
Time frame: Day 5
Venous blood samples collected to examine systemic insulinemia (venous blood insulin concentration (pmol/L)) before, during and after a breakfast (differing in supplemented juice composition) for up to 5 hours postprandial.
Insulin responses
Time frame: Day 10
Venous blood samples collected to examine systemic insulinemia (venous blood insulin concentration (pmol/L)) before, during and after a breakfast (differing in supplemented juice composition) for up to 5 hours postprandial.
Capillary glycaemic responses
Time frame: Baseline
Capillary blood samples collected to examine glycemia before, during and after a breakfast (differing in supplemented juice composition) for up to 5 hours postprandial.
Capillary glycaemic responses
Time frame: Day 5
Capillary blood samples collected to examine glycemia before, during and after a breakfast (differing in supplemented juice composition) for up to 5 hours postprandial.
Capillary glycaemic responses
Time frame: Day 10
Capillary blood samples collected to examine glycemia before, during and after a breakfast (differing in supplemented juice composition) for up to 5 hours postprandial.
6 secondary outcomes
Glycated haemoglobin measure
Time frame: Baseline
Flow cytometry
Time frame: Baseline
Alzheimer disease related biomarkers
Time frame: Baseline
BMI
Time frame: Baseline
Waist/hip circumference (Body composition)
Time frame: Baseline
Systolic/diastolic blood pressure
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2024.
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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.
Dominique Hansen, prof. dr. principal investigator
Hasselt University
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 concentrate, Sugar-sweetened orange-flavoured beverage and Whole orange juice with skin removed in people with Diabetes Mellitus, Type 2, run by Hasselt University at 1 site in Belgium.
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 1 inclusion and 10 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: finished, as of the sponsor's last update on 17 May 2024. 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 Belgium. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Glycaemic responses venous blood (time frame: baseline). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 May 2024.