Post-prandial GlycemiaNCT05112133
Effect of Mulberry Leaf Extract on Glucose Response of a Test Meal
A study testing Mulberry leaf extract and Water in people with Post-prandial Glycemia, run by Société des Produits Nestlé (SPN) at 1 site in Switzerland.
Trial summary
The aim of this study is to test the effects of Mulberry leaf extract on glucose response of a standardized complete meal when taken just before or when mixed with the meal. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Post-prandial Glycemia
- What is being tested?
- Mulberry leaf extract and Water
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteSwitzerland
- Study dates
- 24 Jan 2020to 7 Feb 2020
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male and female participants
- Healthy status (based on anamnesis)
- Age between 18 and 45 years
- BMI between 20 and 29.9 kg/m2
- Ability to understand and sign an informed consent form
Who cannot join
- Pregnant or lactating women
- Major medical/surgical event in the last 3 months potentially interfering with study procedures and assessments
- Known food allergy and intolerance to test product
- Medically known cutaneous hypersensitivity to adhesives and plasters
- Alcohol intake higher than 2 servings per day. A serving is 0.4 dl of strong alcohols, 1 dl of red or white wine, or 3 dl of beer.
- Smokers
- Volunteer who cannot be expected to comply with the protocol
- Subject having a hierarchical link with the research team members.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Nestlé Clinical Research Unit
Lausanne, Canton of Vaud, 1000
About this study
The aim of this study is to test the effects of Mulberry leaf extract on glucose response of a standardized complete meal when taken just before or when mixed with the meal.
- Conditions
- Post-prandial Glycemia
- Being tested
- Mulberry leaf extract, Water
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mulberry leaf extractDietary supplement
Oral administration
WaterDietary supplement
Oral administration
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | Water administrated just before a meal Receives: Dietary Supplement: Water |
| Mulberry leaf extract before | Experimental | 250 mg of Mulberry leaf extract was administered before a standard meal Receives: Dietary Supplement: Mulberry leaf extract |
| Mulberry leaf extract during | Experimental | 250 mg of Mulberry leaf extract was administered during a standard meal Receives: Dietary Supplement: Mulberry leaf extract |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-prandial glucose
Incremental area under the curve
Measured: Hour 0 to hour 3 after standard meal consumption
Secondary outcomes (2)
C max glucose
Incremental C max
Measured: Hour 0 to hour 3 after standard meal consumption
T max glucose
Incremental T max
Measured: Hour 0 to hour 3 after standard meal consumption
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2021
- Study start24 Jan 2020
- Primary completion7 Feb 2020
- Study completion7 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-prandial GlycemiaStudies of the same condition, open and under way.
- More trials run by Société des Produits Nestlé (SPN)The sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05112133
- Sponsor's protocol ID
- 19.09 NRC
- Status last verified
- Oct 2023
- First submitted
- 30 Sep 2021
- Last updated
- 6 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Mulberry Leaf Extract on Glucose Response of a Test Meal
- ClinicalTrials.gov ID
- NCT05112133
- Acronym / sponsor ID
- 19.09 NRC
- Conditions
- Post-prandial Glycemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Study start
- 24 Jan 2020 (actual)
- Primary completion
- 7 Feb 2020 (actual)
- Study completion
- 7 Feb 2020 (actual)
- First posted
- 8 Nov 2021 (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.
The aim of this study is to test the effects of Mulberry leaf extract on glucose response of a standardized complete meal when taken just before or when mixed with the meal.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Dietary Supplement: WaterWater administrated just before a meal |
| Mulberry leaf extract before | Experimental | Dietary Supplement: Mulberry leaf extract250 mg of Mulberry leaf extract was administered before a standard meal |
| Mulberry leaf extract during | Experimental | Dietary Supplement: Mulberry leaf extract250 mg of Mulberry leaf extract was administered during a standard meal |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Male and female participants
- Healthy status (based on anamnesis)
- Age between 18 and 45 years
- BMI between 20 and 29.9 kg/m2
- Ability to understand and sign an informed consent form
Key exclusion criteria (8 listed)
- Pregnant or lactating women
- Major medical/surgical event in the last 3 months potentially interfering with study procedures and assessments
- Known food allergy and intolerance to test product
- Medically known cutaneous hypersensitivity to adhesives and plasters
- Alcohol intake higher than 2 servings per day. A serving is 0.4 dl of strong alcohols, 1 dl of red or white wine, or 3 dl of beer.
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 |
|---|---|---|
| Mulberry leaf extractOral administration | Dietary supplement | Mulberry leaf extract before, Mulberry leaf extract during |
| WaterOral administration | Dietary supplement | Control |
Primary outcome
Post-prandial glucose
Time frame: Hour 0 to hour 3 after standard meal consumption
Incremental area under the curve
2 secondary outcomes
C max glucose
Time frame: Hour 0 to hour 3 after standard meal consumption
T max glucose
Time frame: Hour 0 to hour 3 after standard meal consumption
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 6 Oct 2023.
- Individual participant dataSharing planned: Undecided
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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 Mulberry leaf extract and Water in people with Post-prandial Glycemia, run by Société des Produits Nestlé (SPN) at 1 site in Switzerland.
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 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 6 Oct 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 Switzerland. 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?
Post-prandial glucose (time frame: Hour 0 to hour 3 after standard meal consumption). 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 6 Oct 2023.