HealthyNCT02388503
The Effect of a Natural Extract on the Post-prandial Blood Glucose Response After Bread Consumption: a Dose-response of Efficacy
A study testing no added fruit extract and fruit extract in people with Healthy, run by Unilever R&D at 1 site in Germany.
Trial summary
This study is designed to identify the minimal effective tested dose of fruit extract consumed with a bread which provides a reduction in venous post-prandial blood glucose compared to a reference bread. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- no added fruit extract and fruit extract
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteGermany
- Study dates
- Feb 2015to Mar 2015
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Body mass index (BMI) ≥ 18.0 and ≤ 30.0 kg/m2.
- Apparently healthy males and females: 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 subjects ≥ 3.4 and ≤ 6.1 mmol/litre (i.e. 62-110 mg/dl) at screening.
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.
- Blood donation in the past 3 months and/or during the study.
- Reported intense sporting activities > 10 h/week.
- Consumption of > 14 units (female subjects) and > 21 units (male subjects) alcoholic drinks in a typical week.
- Reported dietary habits: medically prescribed diet, slimming diet, not used to eat 3 meals a day, vegetarian.
- If female, is pregnant (or has been pregnant during the last < 3 months) or will be planning pregnancy during the study period.
- If female, is lactating or has been lactating in the 6 weeks before screening and/or during the study period.
- Dislike, known allergy or intolerance to test products or other food products provided during the study.
Trial locations and contacts
1 site in 1 country.
About this study
This study is designed to identify the minimal effective tested dose of fruit extract consumed with a bread which provides a reduction in venous post-prandial blood glucose compared to a reference bread.
- Conditions
- Healthy
- Being tested
- no added fruit extract, fruit extract
- Keywords
- Blood glucose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no added fruit extractDietary supplement
fruit extractDietary supplement
fruit extractDietary supplement
fruit extractDietary supplement
fruit extractDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Reference | Placebo comparator | No added fruit extract Receives: Dietary Supplement: no added fruit extract |
| Active 1 | Active comparator | lowest dose of fruit extract Receives: Dietary Supplement: fruit extract |
| Active 2 | Active comparator | low dose of fruit extract Receives: Dietary Supplement: fruit extract |
| Active 3 | Active comparator | medium dose of fruit extract Receives: Dietary Supplement: fruit extract |
| Active 4 | Active comparator | high dose of fruit extract Receives: Dietary Supplement: fruit extract |
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive incremental post-prandial blood glucose area under the curve
Measured: 120 minutes
Secondary outcomes (5)
Post-prandial insulin response
Measured: 120 minutes
Post-prandial insulin response
Measured: 180 minutes
AUC of fruit extract calculated by a non-compartmental model
Measured: 180 minutes
AUC of fruit extract calculated by a population model
Measured: 180 minutes
Positive incremental post-prandial blood glucose area under the curve
Measured: 180 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2015 (estimated)
- Study startFeb 2015
- Primary completionMar 2015
- Study completionMar 2015
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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 64 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
- NCT02388503
- Sponsor's protocol ID
- FDS-NAA-1946
- Status last verified
- Apr 2015
- First submitted
- 10 Feb 2015
- Last updated
- 1 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Natural Extract on the Post-prandial Blood Glucose Response After Bread Consumption: a Dose-response of Efficacy
- ClinicalTrials.gov ID
- NCT02388503
- Acronym / sponsor ID
- FDS-NAA-1946
- Conditions
- Healthy
- Keywords
- Blood glucose
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Unilever R&DIndustry (pharma, biotech, devices)
- Study start
- Feb 2015
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 17 Mar 2015 (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 designed to identify the minimal effective tested dose of fruit extract consumed with a bread which provides a reduction in venous post-prandial blood glucose compared to a reference bread.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Reference | Placebo comparator | Dietary Supplement: no added fruit extractNo added fruit extract |
| Active 1 | Active comparator | Dietary Supplement: fruit extractlowest dose of fruit extract |
| Active 2 | Active comparator | Dietary Supplement: fruit extractlow dose of fruit extract |
| Active 3 | Active comparator | Dietary Supplement: fruit extractmedium dose of fruit extract |
| Active 4 | Active comparator | Dietary Supplement: fruit extracthigh dose of fruit extract |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Body mass index (BMI) ≥ 18.0 and ≤ 30.0 kg/m2.
- Apparently healthy males and females: 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 subjects ≥ 3.4 and ≤ 6.1 mmol/litre (i.e. 62-110 mg/dl) at screening.
Key exclusion criteria (8 listed)
- Use of antibiotics within 3 months before day 1; use of any other medication except paracetamol, within 14 days before day 1.
- Blood donation in the past 3 months and/or during the study.
- Reported intense sporting activities > 10 h/week.
- Consumption of > 14 units (female subjects) and > 21 units (male subjects) alcoholic drinks in a typical week.
- Reported dietary habits: medically prescribed diet, slimming diet, not used to eat 3 meals a day, vegetarian.
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 |
|---|---|---|
| no added fruit extract | Dietary supplement | Reference |
| fruit extract | Dietary supplement | Active 1 |
| fruit extract | Dietary supplement | Active 2 |
| fruit extract | Dietary supplement | Active 3 |
| fruit extract | Dietary supplement | Active 4 |
Primary outcome
Positive incremental post-prandial blood glucose area under the curve
Time frame: 120 minutes
5 secondary outcomes
Post-prandial insulin response
Time frame: 120 minutes
Post-prandial insulin response
Time frame: 180 minutes
AUC of fruit extract calculated by a non-compartmental model
Time frame: 180 minutes
AUC of fruit extract calculated by a population model
Time frame: 180 minutes
Positive incremental post-prandial blood glucose area under the curve
Time frame: 180 minutes
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 1 May 2015.
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
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 no added fruit extract and fruit extract in people with Healthy, run by Unilever R&D 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 3 inclusion and 8 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 1 May 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 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. 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?
Positive incremental post-prandial blood glucose area under the curve (time frame: 120 minutes). 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 1 May 2015.