HealthyNCT02599740
Natural Fruit Extract Versus the Assumed Key Active Compound in Reducing the Post-prandial Blood Glucose Level
A study testing Natural fruit extract and Assumed active in people with Healthy, run by Unilever R&D at 1 site in Germany.
Trial summary
This study is designed to test bioequivalence of a assumed key active compound vs. natural fruit extract as judged from the Incremental area under the curve (+iAUC0-2h) for blood glucose: i.e. the 90% confidence interval of the ratio +iAUC0-2h for blood glucose for assumed key active compound vs. 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?
- Natural fruit extract and Assumed active
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2015to Dec 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) ≥ 18.5 and ≤ 25.0 kg/m2.
- Apparently healthy males and females: no medical conditions which might affect the study measurements, absorption, metabolism and distribution (including diabetes type 1 and type 2, gastrointestinal dysfunction, gastrointestinal surgery [with exception of cholecystectomy and appendectomy] 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
- Use of antibiotics within 3 months before day 1; use of any other medication within 14 days before day 1 except for both paracetamol and hormonal contraception.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Bioequivalence of a Natural Extract Versus the Assumed Key Active Compound in Reducing the Post-prandial Blood Glucose Levels
This study is designed to test bioequivalence of a assumed key active compound vs. natural fruit extract as judged from the Incremental area under the curve (+iAUC0-2h) for blood glucose: i.e. the 90% confidence interval of the ratio +iAUC0-2h for blood glucose for assumed key active compound vs. natural extract falls between 0.8 - 1.25.
Read the detailed description
The basic study design for this Williams design consists of six distinct treatment sequences; within each of the treatment sequences the treatments are duplicated.
- Conditions
- Healthy
- Being tested
- Natural fruit extract, Assumed active, Placebo
- Keywords
- Blood glucose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Natural fruit extractOther
Natural fruit extract consumed with rice
Assumed activeOther
Assumed key active consumed with rice
PlaceboOther
Rice only
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Rice only Receives: Other: Placebo |
| Assumed active | Active comparator | Assumed key active consumed with rice Receives: Other: Assumed active |
| Natural fruit extract | Active comparator | Natural fruit extract consumed with rice Receives: Other: Natural fruit extract |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of 2-h Post Prandial Blood Glucose (PPG) based on response to different treatments
+iAUC
Measured: 0-2 hours
Secondary outcomes (7)
Change of 3-h PPG based on response to different treatments
+iAUC
Measured: 0-3 hours
Change of 2-h and 3-h post-prandial insulin based on response to different treatments
tAUC
Measured: 0-2 hours and 0-3 hours
Max plasma concentration for assumed key active
Cmax
Measured: 0-12 hours
Time of max plasma concentration for assumed key active
Tmax
Measured: 0-12 hours
AUC for plasma concentration versus time curve for assumed key active
AUC
Measured: 0-12 hours
Half-life of elimination phase for assumed key active
t1/2
Measured: 0-12 hours
Total amount of assumed key active excreted in urine
Measured: 0-36 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2015 (estimated)
- Study startOct 2015
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Unilever R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Christian Keicher, Dr, Principal investigator, Charité Research Organisation GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02599740
- Sponsor's protocol ID
- FDS-NAA-2093
- Status last verified
- Jan 2016
- First submitted
- 3 Nov 2015
- Last updated
- 15 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Hoogenraad AR, Geldof M, Hiemstra H, de Jong A, Duchateau GS, Mela DJ. Bioequivalence of Mulberry Fruit Extract and 1-Deoxynojirimycin for Postprandial Blood Glucose Lowering: A Randomized Trial in Humans. J Nutr. 2025 Jul;155(7):2164-2171. doi: 10.1016/j.tjnut.2025.05.037. Epub 2025 May 24.
PubMed 40419090
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Bioequivalence of a Natural Extract Versus the Assumed Key Active Compound in Reducing the Post-prandial Blood Glucose Levels
- ClinicalTrials.gov ID
- NCT02599740
- Acronym / sponsor ID
- FDS-NAA-2093
- Conditions
- Healthy
- Keywords
- Blood glucose
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Unilever R&DIndustry (pharma, biotech, devices)
- Study start
- Oct 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 9 Nov 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 test bioequivalence of a assumed key active compound vs. natural fruit extract as judged from the Incremental area under the curve (+iAUC0-2h) for blood glucose: i.e. the 90% confidence interval of the ratio +iAUC0-2h for blood glucose for assumed key active compound vs. natural extract falls between 0.8 - 1.25.
Detailed description
The basic study design for this Williams design consists of six distinct treatment sequences; within each of the treatment sequences the treatments are duplicated.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: PlaceboRice only |
| Assumed active | Active comparator | Other: Assumed activeAssumed key active consumed with rice |
| Natural fruit extract | Active comparator | Other: Natural fruit extractNatural fruit extract consumed with rice |
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) ≥ 18.5 and ≤ 25.0 kg/m2.
- Apparently healthy males and females: no medical conditions which might affect the study measurements, absorption, metabolism and distribution (including diabetes type 1 and type 2, gastrointestinal dysfunction, gastrointestinal surgery [with exception of cholecystectomy and appendectomy] 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 (1 listed)
- Use of antibiotics within 3 months before day 1; use of any other medication within 14 days before day 1 except for both paracetamol and hormonal contraception.
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 extractNatural fruit extract consumed with rice | Other | Natural fruit extract |
| Assumed activeAssumed key active consumed with rice | Other | Assumed active |
| PlaceboRice only | Other | Placebo |
Primary outcome
Change of 2-h Post Prandial Blood Glucose (PPG) based on response to different treatments
Time frame: 0-2 hours
+iAUC
7 secondary outcomes
Change of 3-h PPG based on response to different treatments
Time frame: 0-3 hours
Change of 2-h and 3-h post-prandial insulin based on response to different treatments
Time frame: 0-2 hours and 0-3 hours
Max plasma concentration for assumed key active
Time frame: 0-12 hours
Time of max plasma concentration for assumed key active
Time frame: 0-12 hours
AUC for plasma concentration versus time curve for assumed key active
Time frame: 0-12 hours
Half-life of elimination phase for assumed key active
Time frame: 0-12 hours
Total amount of assumed key active excreted in urine
Time frame: 0-36 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 15 Jan 2016.
- Derived from this study: PubMed 40419090Hoogenraad AR, Geldof M, Hiemstra H, de Jong A, Duchateau GS, Mela DJ. Bioequivalence of Mulberry Fruit Extract and 1-Deoxynojirimycin for Postprandial Blood Glucose Lowering: A Randomized Trial in Humans. J Nutr. 2025 Jul;155(7):2164-2171. doi: 10.1016/j.tjnut.2025.05.037. Epub 2025 May 24.
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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.
Christian Keicher, Dr principal investigator
Charité Research Organisation GmbH
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 Assumed active 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 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 15 Jan 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 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?
Change of 2-h Post Prandial Blood Glucose (PPG) based on response to different treatments (time frame: 0-2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02599740, which also lists 1 linked publication.
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 15 Jan 2016.