HealthyNCT02974478
Orange Juice Consumption and Glucose Metabolism and Antioxidative Status
A study testing Orange juice with meals, Orange juice between meals and Sugar sweetened beverage between meals in people with Healthy, run by University of Hohenheim at 1 site in Germany.
Trial summary
Aim of the study is to investigate the impact of orange juice consumption (with meals or between meals) as well as sugar sweetened beverage (SSB) consumption (between meals) on glucose homeostasis and antioxidative status. Read more about this study
- Who is it for?
- Ages 20 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Orange juice with meals, Orange juice between meals and Sugar sweetened beverage between meals
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2016to Dec 2016
- 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 20 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy
Who cannot join
- regular use of medication,
- smoking,
- chronic disease,
- vegan/vegetarian diet,
- fructose intolerance,
- irregular eating behaviour (less then 3 meals/day)
Trial locations and contacts
1 site in 1 country.
Germany1 site
Institute of Nutritional Medicine, University of Hohenheim
Stuttgart, 70599
About this study
Official title: Impact of Orange Juice Consumption on Glucose Homeostasis and Antioxidative Status in Healthy Subjects
Aim of the study is to investigate the impact of orange juice consumption (with meals or between meals) as well as sugar sweetened beverage (SSB) consumption (between meals) on glucose homeostasis and antioxidative status.
Read the detailed description
Duration of the study is 3x three weeks including one wash-out week each followed by two weeks of juice/SSB consumption under free living conditions.
During wash-out weeks consumption of orange juice or citrus fruits is restricted.
During intervention weeks, participants are asked to eat three regular meals per day without snacking. Intervention weeks are (i) orange juice consumption with meals (ii) orange juice consumption between meals and (iii) SSB consumption between meals. Daily energy intake with orange juice/SSB is 20% of individual energy requirement. Additional caloric beverages (SSB, juice, coffee with sugar/milk, alcohol) are not allowed. At the beginning and the end of each intervention phase insulin sensitivity and antioxidative status are assessed.
- Conditions
- Healthy
- Being tested
- Orange juice with meals, Orange juice between meals, Sugar sweetened beverage between meals
- Keywords
- orange juice consumption, glucose homeostasis, antioxidative status
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Orange juice with mealsDietary supplement
orange juice (20% of energy requirement/day)
Orange juice between mealsDietary supplement
orange juice (20% of energy requirement/day)
Sugar sweetened beverage between mealsDietary supplement
Sugar sweetened beverage (20% of energy requirement/day)
| Study group | Role | What they receive |
|---|---|---|
| Orange juice with meals | Experimental | Effect of orange juice consumption with three meals per day (without snacking) on glucose metabolism and antioxidative status Receives: Dietary Supplement: Orange juice with meals |
| Orange juice between meals | Experimental | Effect of orange juice consumption between three meals per day (without snacking) on glucose metabolism and antioxidative status Receives: Dietary Supplement: Orange juice between meals |
| Sugar sweetened beverage between meals | Experimental | Effect of sugar sweetened beverage consumption between three meals per day (without snacking) on glucose metabolism and antioxidative status Receives: Dietary Supplement: Sugar sweetened beverage between meals |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes in daylong glycaemia between pre and post intervention periods
measured via continuous glucose monitoring [mg/dL]
Measured: two weeks
Secondary outcomes (3)
changes in uric acid between pre and post intervention periods
measured via uric acid serum levels [mg/dL]
Measured: two weeks
changes in insulin sensitivity between pre and post intervention periods
measured via "Matsuda-Index" from oral glucose tolerance test data
Measured: two weeks
changes in antioxidative status between pre and post intervention periods
measured via vitamin c blood levels [mg/L]
Measured: two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2016 (estimated)
- Study startApr 2016
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Hohenheim
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anja Bosy-Westphal, Prof PhD, Principal investigator, University of Hohenheim, Stuttgart, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02974478
- Sponsor's protocol ID
- OrangeJuice
- Status last verified
- Apr 2017
- First submitted
- 2 Nov 2016
- Last updated
- 25 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Orange Juice Consumption on Glucose Homeostasis and Antioxidative Status in Healthy Subjects
- ClinicalTrials.gov ID
- NCT02974478
- Acronym / sponsor ID
- OrangeJuice
- Conditions
- Healthy
- Keywords
- orange juice consumption, glucose homeostasis, antioxidative status
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- University of HohenheimUniversity, hospital or other
- Study start
- Apr 2016 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 28 Nov 2016 (estimated)
- 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.
Aim of the study is to investigate the impact of orange juice consumption (with meals or between meals) as well as sugar sweetened beverage (SSB) consumption (between meals) on glucose homeostasis and antioxidative status.
Detailed description
Duration of the study is 3x three weeks including one wash-out week each followed by two weeks of juice/SSB consumption under free living conditions.
During wash-out weeks consumption of orange juice or citrus fruits is restricted.
During intervention weeks, participants are asked to eat three regular meals per day without snacking. Intervention weeks are (i) orange juice consumption with meals (ii) orange juice consumption between meals and (iii) SSB consumption between meals. Daily energy intake with orange juice/SSB is 20% of individual energy requirement. Additional caloric beverages (SSB, juice, coffee with sugar/milk, alcohol) are not allowed. At the beginning and the end of each intervention phase insulin sensitivity and antioxidative status are assessed.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Orange juice with meals | Experimental | Dietary Supplement: Orange juice with mealsEffect of orange juice consumption with three meals per day (without snacking) on glucose metabolism and antioxidative status |
| Orange juice between meals | Experimental | Dietary Supplement: Orange juice between mealsEffect of orange juice consumption between three meals per day (without snacking) on glucose metabolism and antioxidative status |
| Sugar sweetened beverage between meals | Experimental | Dietary Supplement: Sugar sweetened beverage between mealsEffect of sugar sweetened beverage consumption between three meals per day (without snacking) on glucose metabolism and antioxidative status |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- healthy
Key exclusion criteria (6 listed)
- regular use of medication,
- smoking,
- chronic disease,
- vegan/vegetarian diet,
- fructose intolerance,
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 with mealsorange juice (20% of energy requirement/day) | Dietary supplement | Orange juice with meals |
| Orange juice between mealsorange juice (20% of energy requirement/day) | Dietary supplement | Orange juice between meals |
| Sugar sweetened beverage between mealsSugar sweetened beverage (20% of energy requirement/day) | Dietary supplement | Sugar sweetened beverage between meals |
Primary outcome
changes in daylong glycaemia between pre and post intervention periods
Time frame: two weeks
measured via continuous glucose monitoring [mg/dL]
3 secondary outcomes
changes in uric acid between pre and post intervention periods
Time frame: two weeks
changes in insulin sensitivity between pre and post intervention periods
Time frame: two weeks
changes in antioxidative status between pre and post intervention periods
Time frame: two weeks
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 25 Apr 2017.
- Individual participant dataSharing planned: No
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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.
Anja Bosy-Westphal, Prof PhD principal investigator
University of Hohenheim, Stuttgart, Germany
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 with meals, Orange juice between meals and Sugar sweetened beverage between meals in people with Healthy, run by University of Hohenheim at 1 site in Germany.
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 6 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 25 Apr 2017. 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 Germany. 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?
changes in daylong glycaemia between pre and post intervention periods (time frame: two weeks). 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 25 Apr 2017.