Blood GlucoseNCT04396262
Effect of Processed Blueberry on Blood Glucose and Antioxidant Status in Human Adults
A study testing Food-1 and Food-2 in people with Blood Glucose, run by Mount Saint Vincent University at 1 site in Canada.
Trial summary
Canada's Food Guide (2007) recommended 7-10 servings of fruits and vegetables per day for a normal adult population. Although fruit juice (125 ml) is considered as one serving of fruits, the consumption of some fruit juices may be limited due to their high amount of sugar. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Blood Glucose
- What is being tested?
- Food-1 and Food-2
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteCanada
- Study dates
- 1 Nov 2015to 31 Aug 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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adults
- Body mass index (BMI) within normal range (18.5-24.9 kg/m2 for adults)
Who cannot join
- Chronic metabolic diseases or inflammatory conditions
- Smokers
- A medication that influences glucose control or gastrointestinal function
- Known allergies
- Intellectual disabilities
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Hydro-Thermodynamic (HTD) Processed Blueberries on Postprandial Blood Glucose Control and Antioxidant Status in Human Adults
Canada's Food Guide (2007) recommended 7-10 servings of fruits and vegetables per day for a normal adult population. Although fruit juice (125 ml) is considered as one serving of fruits, the consumption of some fruit juices may be limited due to their high amount of sugar. The consumption of sugary drinks can lead to a rapid rise in postprandial glycaemia. Wild blueberries, due to their high level of anthocyanins, may provide multiple health benefits including improved blood glucose control, however, the consumption of fresh berries is limited by their short seasonal availability. Hydro-Thermodynamic (HTD) processing of blueberries allows the processing of whole berries including their skin and seeds into a beverage with the amount of anthocyanins comparable with fresh berries. The objective of the study is to investigate the effect of HTD-processed blueberries on postprandial glycaemia and antioxidant activity.
- Conditions
- Blood Glucose
- Being tested
- Food-1, Food-2
- Keywords
- Blueberry, Blood Glucose, Antioxidants, Hydro-Thermodynamic Processing, Beverages
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Food-1Other
HTD-blueberry beverage with white bread.
Food-2Other
Sweetened water with white bread as a control.
| Study group | Role | What they receive |
|---|---|---|
| HTD-blueberry beverage with white bread | Experimental | The beverage prepared using hydro-thermodynamic processing of whole wild blueberries. Receives: Other: Food-1 |
| Sweetened water (control) with white bread | Experimental | The water control of the same volume and with the same amount of available carbohydrate as HTD-blueberry beverage. Receives: Other: Food-2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood glucose
The concentration of glucose in venous blood after consuming HTD-blueberry beverage with white bread or water control with white bread.
Measured: 0-120 min
Secondary outcomes (1)
Postprandial antioxidant activity in blood
The total antioxidant activity in blood plasma determined using a commercial Antioxidant Assay Kit.
Measured: 0-120 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2020
- Study start1 Nov 2015
- Primary completion31 Aug 2016
- Study completion31 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood GlucoseStudies 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
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mount Saint Vincent University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bohdan Luhovyy, PhD, Principal investigator, Mount Saint Vincent University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04396262
- Sponsor's protocol ID
- 2019-204
- Other IDs
- 2015-102
- Status last verified
- Mar 2023
- First submitted
- 1 Apr 2020
- Last updated
- 20 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Hydro-Thermodynamic (HTD) Processed Blueberries on Postprandial Blood Glucose Control and Antioxidant Status in Human Adults
- ClinicalTrials.gov ID
- NCT04396262
- Acronym / sponsor ID
- 2019-204
- Conditions
- Blood Glucose
- Keywords
- Blueberry, Blood Glucose, Antioxidants, Hydro-Thermodynamic Processing, Beverages
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Mount Saint Vincent UniversityUniversity, hospital or other
- Study start
- 1 Nov 2015 (actual)
- Primary completion
- 31 Aug 2016 (actual)
- Study completion
- 31 Aug 2022 (actual)
- First posted
- 20 May 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.
Canada's Food Guide (2007) recommended 7-10 servings of fruits and vegetables per day for a normal adult population. Although fruit juice (125 ml) is considered as one serving of fruits, the consumption of some fruit juices may be limited due to their high amount of sugar. The consumption of sugary drinks can lead to a rapid rise in postprandial glycaemia. Wild blueberries, due to their high level of anthocyanins, may provide multiple health benefits including improved blood glucose control, however, the consumption of fresh berries is limited by their short seasonal availability. Hydro-Thermodynamic (HTD) processing of blueberries allows the processing of whole berries including their skin and seeds into a beverage with the amount of anthocyanins comparable with fresh berries. The objective of the study is to investigate the effect of HTD-processed blueberries on postprandial glycaemia and antioxidant activity.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HTD-blueberry beverage with white bread | Experimental | Other: Food-1The beverage prepared using hydro-thermodynamic processing of whole wild blueberries. |
| Sweetened water (control) with white bread | Experimental | Other: Food-2The water control of the same volume and with the same amount of available carbohydrate as HTD-blueberry beverage. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy adults
- Body mass index (BMI) within normal range (18.5-24.9 kg/m2 for adults)
Key exclusion criteria (5 listed)
- Chronic metabolic diseases or inflammatory conditions
- Smokers
- A medication that influences glucose control or gastrointestinal function
- Known allergies
- Intellectual disabilities
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 |
|---|---|---|
| Food-1HTD-blueberry beverage with white bread. | Other | HTD-blueberry beverage with white bread |
| Food-2Sweetened water with white bread as a control. | Other | Sweetened water (control) with white bread |
Primary outcome
Blood glucose
Time frame: 0-120 min
The concentration of glucose in venous blood after consuming HTD-blueberry beverage with white bread or water control with white bread.
1 secondary outcome
Postprandial antioxidant activity in blood
Time frame: 0-120 min
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 20 Mar 2023.
- 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.
Bohdan Luhovyy, PhD principal investigator
Mount Saint Vincent 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 Food-1 and Food-2 in people with Blood Glucose, run by Mount Saint Vincent University at 1 site in Canada.
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 2 inclusion and 5 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 20 Mar 2023. 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 Canada. 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?
Blood glucose (time frame: 0-120 min). 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 20 Mar 2023.