HealthyNCT02662738
The Effect of a Natural Extract on Glucose Fluxes After Consumption of a Wheat Product
A study testing Natural fruit extract and Glucose solution in people with Healthy, run by Unilever R&D at 1 site in Netherlands.
Trial summary
This study is to quantify the effect of a natural fruit extract added to a wheat product on the time needed to absorb 50% of the apparent total of available exogenous carbohydrate (RaE * Time). In addition the different glucose fluxes will be quantified (RaE, EGP and GCR) Read more about this study
- Who is it for?
- Ages 20 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Natural fruit extract and Glucose solution
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteNetherlands
- Study dates
- Jan 2016to Feb 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 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy Caucasian male.
- Body mass index (BMI) ≥ 18.0 and ≤ 25.0 kg/m2.
- Apparently healthy: no medical conditions which might affect the study measurements including diabetes type 1 and type 2, gastrointestinal dysfunction, gastrointestinal surgery and inflammatory diseases.
- Fasting blood glucose value of volunteer is ≥ 3.4 and ≤ 6.1 mmol/liter (i.e. 62- 110 mg/dl) at screening.
- HbA1c ≤ 6.5 % (48 mmol/mol).
Who cannot join
- Use of antibiotics within 3 months before Day 1; use of any other medication except paracetamol within 14 days before Day 1.
Trial locations and contacts
1 site in 1 country.
About this study
This study is to quantify the effect of a natural fruit extract added to a wheat product on the time needed to absorb 50% of the apparent total of available exogenous carbohydrate (RaE * Time). In addition the different glucose fluxes will be quantified (RaE, EGP and GCR)
- Conditions
- Healthy
- Being tested
- Natural fruit extract, Placebo, Glucose solution
- Keywords
- Blood glucose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Natural fruit extractDietary supplement
PlaceboOther
Glucose solutionOther
| Study group | Role | What they receive |
|---|---|---|
| A wheat product | Active comparator | A wheat product (containing 2% 13C-universally-labeled wheat) with natural fruit extract added. Receives: Dietary Supplement: Natural fruit extract |
| Control | Placebo comparator | A wheat product (containing 2% 13C-universally-labeled wheat) without natural fruit extract added. Receives: Other: Placebo |
| Glucose solution | Other | A solution of 50g glucose of which 2% 13C-universally-labeled glucose (2%) and unlabeled glucose (98%) in 250 mL water. Receives: Other: Glucose solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
13C (13 carbon) and D-[6,6-2H2] glucose
Measured: 0-6 hours
Secondary outcomes (11)
Total blood glucose (BG)
Measured: 0-2 hours and 0-4 hours
Insulin
Measured: 0-2 hours and 0-4 hours
Endogenous glucose production (EGP)
Measured: 0-2 hours and 0-4 hours
Glucose clearance rate (GCR)
Measured: 0-2 hours and 0-4 hours
13C Metabolites of glucose (metabolomics)
Measured: 0-2 hours and 0-4 hours
12C Metabolites of glucose (metabolomics)
Measured: 0-2 hours and 0-4 hours
Postprandial hormones (Gastric inhibitory polypeptide, glucagon-like peptide-1 and Glucagon)
Measured: 0-2 hours and 0-4 hours
Selected anti-oxidants (vitamin E (alpha-tocopherol), lycopene, retinol, alpha-carotene and beta-carotene)
Measured: -5, 60, 120, 180, 240 and 300 minutes
Haematocrit
Measured: -5, 60, 120, 180, 240 and 300 minutes
Concentration of key active in extract
Measured: -5, 15, 30, 45, 60, 90, 120, 150, 180, 240, 300 and 360 minutes
13CO2 in breath
Measured: 30, 30, 60, 90,120, 150, 180 and every 30 minutes up to 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2016 (estimated)
- Study startJan 2016
- Primary completionFeb 2016
- Study completionFeb 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
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Unilever R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tjeerd Mensinga, MD, PhD, Principal investigator, QPS Netherlands
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02662738
- Sponsor's protocol ID
- FDS-NAA-1650
- Status last verified
- Oct 2016
- First submitted
- 20 Jan 2016
- Last updated
- 26 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Natural Extract on Glucose Fluxes After Consumption of a Wheat Product
- ClinicalTrials.gov ID
- NCT02662738
- Acronym / sponsor ID
- FDS-NAA-1650
- Conditions
- Healthy
- Keywords
- Blood glucose
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Unilever R&DIndustry (pharma, biotech, devices)
- Study start
- Jan 2016
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 25 Jan 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.
This study is to quantify the effect of a natural fruit extract added to a wheat product on the time needed to absorb 50% of the apparent total of available exogenous carbohydrate (RaE * Time). In addition the different glucose fluxes will be quantified (RaE, EGP and GCR)
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A wheat product | Active comparator | Dietary Supplement: Natural fruit extractA wheat product (containing 2% 13C-universally-labeled wheat) with natural fruit extract added. |
| Control | Placebo comparator | Other: PlaceboA wheat product (containing 2% 13C-universally-labeled wheat) without natural fruit extract added. |
| Glucose solution | Other | Other: Glucose solutionA solution of 50g glucose of which 2% 13C-universally-labeled glucose (2%) and unlabeled glucose (98%) in 250 mL water. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy Caucasian male.
- Body mass index (BMI) ≥ 18.0 and ≤ 25.0 kg/m2.
- Apparently healthy: no medical conditions which might affect the study measurements including diabetes type 1 and type 2, gastrointestinal dysfunction, gastrointestinal surgery and inflammatory diseases.
- Fasting blood glucose value of volunteer is ≥ 3.4 and ≤ 6.1 mmol/liter (i.e. 62- 110 mg/dl) at screening.
- HbA1c ≤ 6.5 % (48 mmol/mol).
Key exclusion criteria (1 listed)
- Use of antibiotics within 3 months before Day 1; use of any other medication except paracetamol within 14 days before Day 1.
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 |
|---|---|---|
| Natural fruit extract | Dietary supplement | A wheat product |
| Placebo | Other | Control |
| Glucose solution | Other | Glucose solution |
Primary outcome
13C (13 carbon) and D-[6,6-2H2] glucose
Time frame: 0-6 hours
11 secondary outcomes
Total blood glucose (BG)
Time frame: 0-2 hours and 0-4 hours
Insulin
Time frame: 0-2 hours and 0-4 hours
Endogenous glucose production (EGP)
Time frame: 0-2 hours and 0-4 hours
Glucose clearance rate (GCR)
Time frame: 0-2 hours and 0-4 hours
13C Metabolites of glucose (metabolomics)
Time frame: 0-2 hours and 0-4 hours
12C Metabolites of glucose (metabolomics)
Time frame: 0-2 hours and 0-4 hours
Postprandial hormones (Gastric inhibitory polypeptide, glucagon-like peptide-1 and Glucagon)
Time frame: 0-2 hours and 0-4 hours
Selected anti-oxidants (vitamin E (alpha-tocopherol), lycopene, retinol, alpha-carotene and beta-carotene)
Time frame: -5, 60, 120, 180, 240 and 300 minutes
Haematocrit
Time frame: -5, 60, 120, 180, 240 and 300 minutes
Concentration of key active in extract
Time frame: -5, 15, 30, 45, 60, 90, 120, 150, 180, 240, 300 and 360 minutes
13CO2 in breath
Time frame: 30, 30, 60, 90,120, 150, 180 and every 30 minutes up to 6 hours
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 26 Oct 2016.
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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.
Tjeerd Mensinga, MD, PhD principal investigator
QPS Netherlands
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Natural fruit extract and Glucose solution in people with Healthy, run by Unilever R&D at 1 site in Netherlands.
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 1 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 26 Oct 2016. 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 Netherlands. 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. Some participants in this study may receive a placebo. 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?
13C (13 carbon) and D-[6,6-2H2] glucose (time frame: 0-6 hours). 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 26 Oct 2016.