Back to resultsOrange Juice and Glycaemic Control in Type 2 Diabetes Mellitus
Primary Purpose
Diabetes Mellitus, Type 2
Status
Unknown status
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
orange juice concentrate
Sugar-sweetened orange-flavoured beverage
Whole orange juice with skin removed
Sponsored by
About this trial
This is an interventional other trial for Diabetes Mellitus, Type 2
Eligibility Criteria
Inclusion Criteria:
- Inclusion Criteria: Male individuals (aged 25-65 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)).
Exclusion Criteria:
- participants on exogenous insulin therapy,
- HbA1c >8.5%,
- BMI <27 or >33 kg/m²,
- regular smokers (>1 cigarette per day),
- participants with established cardiovascular disease,
- neurological disease,
- cancer,
- renal disease.
- Participants who are unwilling to consume any of the standard foods/drinks
Sites / Locations
- Hasselt UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Other
Other
Other
Arm Label
group 1
Group 2
Group 3
Arm Description
orange juice concentrate
Sugar-sweetened orange-flavoured beverage
Whole orange juice with skin removed
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
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.
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.
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.
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.
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.
Secondary Outcome Measures
Glycated haemoglobin measure
Measured on a single blood sample to characterize patients' overall glycaemic contro
Flow cytometry
Fasting venous blood samples collected to examine Peripheral blood mononuclear cells (flow cytometry) to measure immunological parameters
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)
BMI
body weight/height (to determine BMI)
Waist/hip circumference (Body composition)
Waist/hip circumference
Systolic/diastolic blood pressure
Systolic/diastolic blood pressure
Full Information
NCT ID
NCT04412798
First Posted
May 29, 2020
Last Updated
December 28, 2020
Sponsor
Hasselt University
Collaborators
Hochschule Geisenheim University
1. Study Identification
Unique Protocol Identification Number
NCT04412798
Brief Title
Orange Juice and Glycaemic Control in Type 2 Diabetes Mellitus
Official Title
Impact of Orange Juice During Breakfast on Glycaemic Control in Individuals With Type 2 Diabetes Mellitus
Study Type
Interventional
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Unknown status
Study Start Date
May 1, 2020 (Actual)
Primary Completion Date
June 30, 2021 (Anticipated)
Study Completion Date
June 30, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hasselt University
Collaborators
Hochschule Geisenheim University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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. 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
18 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
group 1
Arm Type
Other
Arm Description
orange juice concentrate
Arm Title
Group 2
Arm Type
Other
Arm Description
Sugar-sweetened orange-flavoured beverage
Arm Title
Group 3
Arm Type
Other
Arm Description
Whole orange juice with skin removed
Intervention Type
Other
Intervention Name(s)
orange juice concentrate
Intervention Description
250mL of 100% orange juice made from concentrate
Intervention Type
Other
Intervention Name(s)
Sugar-sweetened orange-flavoured beverage
Intervention Description
Sugar-sweetened orange-flavoured beverage, energy-matched to the orange juice condition
Intervention Type
Other
Intervention Name(s)
Whole orange juice with skin removed
Intervention Description
Whole orange pieces with skin removed, energy-matched to the orange juice condition
Primary Outcome Measure Information:
Title
Glycaemic responses venous blood
Description
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.
Time Frame
baseline
Title
Glycaemic responses venous blood
Description
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.
Time Frame
Day 5
Title
Glycaemic responses venous blood
Description
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.
Time Frame
Day 10
Title
Insulin responses
Description
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.
Time Frame
Baseline
Title
Insulin responses
Description
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.
Time Frame
Day 5
Title
Insulin responses
Description
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.
Time Frame
Day 10
Title
Capillary glycaemic responses
Description
Capillary blood samples collected to examine glycemia before, during and after a breakfast (differing in supplemented juice composition) for up to 5 hours postprandial.
Time Frame
Baseline
Title
Capillary glycaemic responses
Description
Capillary blood samples collected to examine glycemia before, during and after a breakfast (differing in supplemented juice composition) for up to 5 hours postprandial.
Time Frame
Day 5
Title
Capillary glycaemic responses
Description
Capillary blood samples collected to examine glycemia before, during and after a breakfast (differing in supplemented juice composition) for up to 5 hours postprandial.
Time Frame
Day 10
Secondary Outcome Measure Information:
Title
Glycated haemoglobin measure
Description
Measured on a single blood sample to characterize patients' overall glycaemic contro
Time Frame
Baseline
Title
Flow cytometry
Description
Fasting venous blood samples collected to examine Peripheral blood mononuclear cells (flow cytometry) to measure immunological parameters
Time Frame
Baseline
Title
Alzheimer disease related biomarkers
Description
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)
Time Frame
Baseline
Title
BMI
Description
body weight/height (to determine BMI)
Time Frame
Baseline
Title
Waist/hip circumference (Body composition)
Description
Waist/hip circumference
Time Frame
Baseline
Title
Systolic/diastolic blood pressure
Description
Systolic/diastolic blood pressure
Time Frame
Baseline
10. Eligibility
Sex
Male
Gender Based
Yes
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Inclusion Criteria: Male individuals (aged 25-65 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)).
Exclusion Criteria:
participants on exogenous insulin therapy,
HbA1c >8.5%,
BMI <27 or >33 kg/m²,
regular smokers (>1 cigarette per day),
participants with established cardiovascular disease,
neurological disease,
cancer,
renal disease.
Participants who are unwilling to consume any of the standard foods/drinks
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dominique Hansen, prof. dr.
Phone
+32 11 29 21 26
Email
dominique.hansen@uhasselt.be
First Name & Middle Initial & Last Name or Official Title & Degree
Kenneth Verboven, dr.
Phone
+32 11 28 69 49
Email
kenneth.verboven@uhasselt.be
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dominique Hansen, prof. dr.
Organizational Affiliation
Hasselt University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hasselt University
City
Hasselt
ZIP/Postal Code
3500
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dominique Hansen, prof. dr.
Phone
+32 11 29 21 26
Email
dominique.hansen@uhasselt.be
First Name & Middle Initial & Last Name & Degree
Dominique Hansen, prof. dr.
12. IPD Sharing Statement
Learn more about this trial
Orange Juice and Glycaemic Control in Type 2 Diabetes Mellitus
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