HealthyNCT02168296
Pharmacokinetics of Plant-based Ingredient
A study testing Plant-based ingredient added to starchy meal, Plant-based ingredient added to liquid and No Plant-based ingredient in people with Healthy, run by Unilever R&D at 1 site in France.
Trial summary
The study is designed to explore the pharmacokinetics of a Plant-based ingredient in two different matrices, at different dose levels. 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?
- Plant-based ingredient added to starchy meal, Plant-based ingredient added to liquid and No Plant-based ingredient
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2014to Oct 2014
- 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 males, age at start of the study 20 and 50 years
- Body mass index (BMI) ≥ 20,0 and ≤ 25,0 kg/m2
- Apparently healthy: no medical conditions which might affect the study measurements, absorption, metabolism and distribution (including diabetes type 1 and type 2, gastrointestinal dysfunction, gastrointestinal surgery and inflammatory diseases)
- Fasting blood glucose value of subjects is ≥ 3.4 and ≤ 6.1 mmol/litre (i.e. 62-110 mg/dl) at screening
Who cannot join
- Any history of diabetes, hyper- (or hypo-) glycemia or other disorder of glucose metabolism
- Any history of gastro-intestinal disorders (including frequent diarrhoea for example)
- Blood donation in the past 2 months
- Reported participation in another nutritional or biomedical trial 3 months before the pre-study examination or during the study
- Reported intense sporting activities > 10 h/w
- Consumption of > 21 alcoholic drinks in a typical week
Show all 14Show fewer
- Not being used to eat breakfast
- Reported use of any nicotine containing products in the six months preceding the study and during the study itself
- Use of medication which interferes with study measurements
- Reported dietary habits: medically prescribed diet, slimming diet
- Not used to eat 3 meals a day
- Vegetarian
- Reported weight loss/gain (>10%) in the last six month before the study;
- Allergy or intolerance to food products and aversion to food products;
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Exploratory Study to Assess the Pharmacokinetics in Relation to Blood Glucose and Insulin Levels After Intake of a Plant-based Ingredient in Healthy Subjects
The study is designed to explore the pharmacokinetics of a Plant-based ingredient in two different matrices, at different dose levels.
- Conditions
- Healthy
- Being tested
- Plant-based ingredient added to starchy meal, Plant-based ingredient added to liquid, No Plant-based ingredient
- Keywords
- Pharmacokinetics, Blood glucose, subjects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plant-based ingredient added to starchy mealDietary supplement
Plant-based ingredient added to liquidDietary supplement
No Plant-based ingredientDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| No added Plant-based ingredient | Placebo comparator | No Plant-based ingredient added to starchy meal Receives: Dietary Supplement: No Plant-based ingredient |
| Low dose added to starchy meal | Active comparator | Plant-based ingredient in low dose added to starchy meal Receives: Dietary Supplement: Plant-based ingredient added to starchy meal |
| High dose added to starchy meal | Active comparator | Plant-based ingredient in high dose added to starchy meal Receives: Dietary Supplement: Plant-based ingredient added to starchy meal |
| Low dose added to liquid | Active comparator | Plant-based ingredient in low dose added to liquid Receives: Dietary Supplement: Plant-based ingredient added to liquid |
| High dose added to liquid | Active comparator | Plant-based ingredient in high dose added to liquid Receives: Dietary Supplement: Plant-based ingredient added to liquid |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC of the plant based ingredient calculated by a non-compartmental model
Measured: predose, 15min, 30min, 45min, 1h, 1.5hrs, 2hrs, 3hrs, 5hrs, 8hrs, 12hrs.
Secondary outcomes (2)
AUC of the plant based ingredient calculated by a compartmental model
Measured: predose, 15min, 30min, 45min, 1hr, 1.5hrs, 2hrs, 3hrs, 5hrs, 8hrs, 12hrs.
Urinary excretion of Plant-based ingredient
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2014 (estimated)
- Study startJun 2014
- Primary completionOct 2014
- Study completionOct 2014
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
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Unilever R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02168296
- Sponsor's protocol ID
- FDS-NAA-1602
- Status last verified
- Jun 2014
- First submitted
- 29 Apr 2014
- Last updated
- 18 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Study to Assess the Pharmacokinetics in Relation to Blood Glucose and Insulin Levels After Intake of a Plant-based Ingredient in Healthy Subjects
- ClinicalTrials.gov ID
- NCT02168296
- Acronym / sponsor ID
- FDS-NAA-1602
- Conditions
- Healthy
- Keywords
- Pharmacokinetics, Blood glucose, subjects
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Unilever R&DIndustry (pharma, biotech, devices)
- Study start
- Jun 2014
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 20 Jun 2014 (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.
The study is designed to explore the pharmacokinetics of a Plant-based ingredient in two different matrices, at different dose levels.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| No added Plant-based ingredient | Placebo comparator | Dietary Supplement: No Plant-based ingredientNo Plant-based ingredient added to starchy meal |
| Low dose added to starchy meal | Active comparator | Dietary Supplement: Plant-based ingredient added to starchy mealPlant-based ingredient in low dose added to starchy meal |
| High dose added to starchy meal | Active comparator | Dietary Supplement: Plant-based ingredient added to starchy mealPlant-based ingredient in high dose added to starchy meal |
| Low dose added to liquid | Active comparator | Dietary Supplement: Plant-based ingredient added to liquidPlant-based ingredient in low dose added to liquid |
| High dose added to liquid | Active comparator | Dietary Supplement: Plant-based ingredient added to liquidPlant-based ingredient in high dose added to liquid |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy males, age at start of the study 20 and 50 years
- Body mass index (BMI) ≥ 20,0 and ≤ 25,0 kg/m2
- Apparently healthy: no medical conditions which might affect the study measurements, absorption, metabolism and distribution (including diabetes type 1 and type 2, gastrointestinal dysfunction, gastrointestinal surgery and inflammatory diseases)
- Fasting blood glucose value of subjects is ≥ 3.4 and ≤ 6.1 mmol/litre (i.e. 62-110 mg/dl) at screening
Key exclusion criteria (14 listed)
- Any history of diabetes, hyper- (or hypo-) glycemia or other disorder of glucose metabolism
- Any history of gastro-intestinal disorders (including frequent diarrhoea for example)
- Blood donation in the past 2 months
- Reported participation in another nutritional or biomedical trial 3 months before the pre-study examination or during the study
- Reported intense sporting activities > 10 h/w
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 |
|---|---|---|
| Plant-based ingredient added to starchy meal | Dietary supplement | High dose added to starchy meal, Low dose added to starchy meal |
| Plant-based ingredient added to liquid | Dietary supplement | High dose added to liquid, Low dose added to liquid |
| No Plant-based ingredient | Dietary supplement | No added Plant-based ingredient |
Primary outcome
AUC of the plant based ingredient calculated by a non-compartmental model
Time frame: predose, 15min, 30min, 45min, 1h, 1.5hrs, 2hrs, 3hrs, 5hrs, 8hrs, 12hrs.
2 secondary outcomes
AUC of the plant based ingredient calculated by a compartmental model
Time frame: predose, 15min, 30min, 45min, 1hr, 1.5hrs, 2hrs, 3hrs, 5hrs, 8hrs, 12hrs.
Urinary excretion of Plant-based ingredient
Time frame: 24 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 18 Feb 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Plant-based ingredient added to starchy meal, Plant-based ingredient added to liquid and No Plant-based ingredient in people with Healthy, run by Unilever R&D at 1 site in France.
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 4 inclusion and 14 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 18 Feb 2015. 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 France. 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?
AUC of the plant based ingredient calculated by a non-compartmental model (time frame: predose, 15min, 30min, 45min, 1h, 1.5hrs, 2hrs, 3hrs, 5hrs, 8hrs, 12hrs.). 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 18 Feb 2015.