Blood GlucoseNCT04258501
Exploratory Study of Efficacy on Selected Natural Extracts Reducing Post Prandial Blood Glucose Response
A study testing Mulberry fruit, Mulberry leaf and White bean in people with Blood Glucose, run by Unilever R&D at 1 site in India.
Trial summary
Randomized, balanced, incomplete block design exploratory study of efficacy, with 8 active treatments (4 treatments per subject; 35 or 37 subjects per treatment) compared to a reference treatment (all 72 subjects). Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Blood Glucose
- What is being tested?
- Mulberry fruit, Mulberry leaf and White bean
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteIndia
- Study dates
- 24 Nov 2011to 6 Jan 2012
- 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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Is the volunteer willing to give his consent to participate in the study in writing?
- Is the volunteer between the age of >20 and <50 yrs?
- Is the volunteer's Body Mass Index (BMI) in between >18 and <25 kg/m2?
- Lactase deficient as indicated by screening test1
- Is the volunteer apparently healthy? [No medical conditions which might affect study measurement, as judged by study physician or measured by questionnaire, and/or assessed by haematology, blood chemistry and urinalysis]
- Is the volunteer willing to comply to study protocol during the study?
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- Is the volunteer agreeing to be informed about medically relevant personal test-results by study physician?
- Is the volunteer willing to refrain from drinking of alcohol on and one day before the blood withdrawal?
- Is the fasting blood glucose value of the volunteer is >3.4 and <6.1 mmol/ litre (i.e. 62-110 mg/dl)?
- Is the Haemoglobin level within normal reference range as judged by the research physician?
- Is the volunteer literate?
Who cannot join
- Is the volunteer an employee of Unilever, Hindustan Lever, or Lambda Therapeutics Research?
- Has the volunteer participated in any other biomedical study 3 months before screening visit day of this study and/or participating in any other biomedical study during the study period?
- Does the volunteer take too much of alcohol (> 120 ml / week)?
- Is the volunteer on a medically prescribed/slimming diet?
- Does the volunteer work in night shifts (between 23.00 and 6.00 hrs) in the week preceding or during the study?
- Is the volunteer using any medication including traditional medicines, vitamins, tonics which might interfere with study measurements, as judged by the PI and/or study physician?
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- Does the volunteer engage in intense exercise > 10h/week? (Intense exercise is defined as exercise which induces sweating and causes sufficient breathlessness to limit conversation)
- Has the volunteer reported weight loss/gain > 10% of body weight in the 6 months preceding screening?
- Has the volunteer donated any blood for 2 months prior to screening visit?
- Does the volunteer urine analysis show any drug abuse?
- Is the volunteer allergic to any food or cosmetics?
- Does the volunteer smoke or consume tobacco in any form, and/or was smoking or consuming tobacco in any form for 6 months preceding the study and/or will be smoking or consuming tobacco in any form, during the study?
- If female, is the volunteer pregnant or will she be planning pregnancy during the study period?
- If female, is the volunteer lactating or has been lactating for 6 weeks before pre-study investigation and/or during the study period?
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Exploratory Study of Efficacy and Tolerance on Selected Natural Extracts, With the Potential of Reducing Post Prandial Blood Glucose Response, in Healthy Indian Adult Subjects
Randomized, balanced, incomplete block design exploratory study of efficacy, with 8 active treatments (4 treatments per subject; 35 or 37 subjects per treatment) compared to a reference treatment (all 72 subjects).
Read the detailed description
Incomplete block design cross over study in which the subjects consumed commercial rice porridge (60 grams of extruded rice to which 300 ml of boiling water was added) in the morning in a fasted state. On each visit one of the seven different natural exacts was mixed into this porridge just before consumption. The reference was consumed by all subjects and consisted of plain porridge with no extract added.
- Conditions
- Blood Glucose
- Being tested
- Mulberry fruit, Mulberry leaf, White bean, Apple, Elderberry
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mulberry fruitOther
Mulberry leafOther
White beanOther
AppleOther
ElderberryOther
TurmericOther
Rice porridgeOther
| Study group | Role | What they receive |
|---|---|---|
| Mulberry fruit extract | Experimental | 1.5 g of mulberry fruit powdered extract mixed into a bowl containing 60 g of extruded rice + 300 ml of boiling water Receives: Other: Mulberry fruit |
| Mulberry leaf extract | Experimental | 1.0 g of mulberry leaf powdered extract mixed into aa bowl containing 60 g of extruded rice + 300 ml of boiling water Receives: Other: Mulberry leaf |
| White bean extract | Experimental | 3 g of white bean powdered extract mixed into a bowl containing 60 g of extruded rice + 300 ml of boiling water Receives: Other: White bean |
| Apple extract | Experimental | 2 g of apple powdered extract standardized in phloridzin mixed into a bowl containing 60 g of extruded rice + 300 ml of boiling water Receives: Other: Apple |
| Elderberry extract | Experimental | 2 g of elderberry powder extract mixed into a bowl containing 60 g of extruded rice + 300 ml of boiling water Receives: Other: Elderberry |
| Turmeric extract | Experimental | 0.18 g of curcumin powdered extract mixed into a bowl containing 60 g of extruded rice + 300 ml of boiling water Receives: Other: Turmeric |
| Turmeric extract + Apple extract | Experimental | 0.18 g of curcumin powdered extract + 2 g of apple powdered extract standardized in phloridzin mixed into a bowl containing 60 g of extruded rice + 300 ml of boiling water Receives: Other: Apple; Other: Turmeric |
| Turmeric extract + Elderberry extract | Experimental | 0.18 g of curcumin powdered extract + 2 g of elderberry powder extract mixed into aa bowl containing 60 g of extruded rice + 300 ml of boiling water Receives: Other: Elderberry; Other: Turmeric |
| Rice porridge control | Placebo comparator | Bowl containing 60 g of extruded rice + 300 ml of boiling water Receives: Other: Rice porridge |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-prandial blood glucose
Glucose concentration in venous plasma
Measured: Positive incremental Area under the glucose versus time Curve between 0 (before) and 2 hours.
Secondary outcomes (3)
Breath hydrogen excretion
Hydrogen gas in exhaled breath. When a subject produced 10 ppm hydrogen or more above the basal breath hydrogen level the treatment was regarded as a "positive"
Measured: Fifteen minutes before (basal) and 65, 125, 185, 245, 305, 365 and 425 minutes after the ingestion of the test products
Intestinal discomfort
An intestinal discomfort questionnaire was administered. The questionnaire asked whether subjects had experienced 1) flatulence, 2) nausea, 3) bloating or 4) pain in the bowels. Percentage of "Yes" scores was calculated per discomfort.
Measured: Ten minutes before (baseline) and at 130, 250, 370 and 420 minutes after the ingestion of the test products.
Stool consistency and number of stools
Stool consistency was evaluated by semi-quantitative Bristol scale (score between 1 = constipation and 7 = watery diarrhea).
Measured: 24 hours before study product intake, during 7 hour the test day and in the 17 hours after the test day (telephone interview).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2020
- Study start24 Nov 2011
- Primary completion6 Jan 2012
- Study completion6 Jan 2012
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 Blood GlucoseStudies 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
- Model description
- Randomized, balanced, incomplete block design exploratory study of efficacy, with 8 active treatments (4 treatments per subject; 35 or 37 subjects per treatment) compared to a reference treatment (all 72 subjects).
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Unilever R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Lambda Therapeutic Research Ltd.
- Responsible party
- Sponsor
- Investigators
- David Mela, Dr., Study director, Unilever R&D Vlaardingen (retired)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04258501
- Sponsor's protocol ID
- FDS-NAA-0334
- Status last verified
- Feb 2020
- First submitted
- 31 Jan 2020
- Last updated
- 6 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mela DJ, Cao XZ, Dobriyal R, Fowler MI, Lin L, Joshi M, Mulder TJP, Murray PG, Peters HPF, Vermeer MA, Zhang Z. The effect of 8 plant extracts and combinations on post-prandial blood glucose and insulin responses in healthy adults: a randomized controlled trial. Nutr Metab (Lond). 2020 Jul 6;17:51. doi: 10.1186/s12986-020-00471-x. eCollection 2020.
PubMed 32647531
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Study of Efficacy and Tolerance on Selected Natural Extracts, With the Potential of Reducing Post Prandial Blood Glucose Response, in Healthy Indian Adult Subjects
- ClinicalTrials.gov ID
- NCT04258501
- Acronym / sponsor ID
- FDS-NAA-0334
- Conditions
- Blood Glucose
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Unilever R&DIndustry (pharma, biotech, devices)
- Collaborators
- Lambda Therapeutic Research Ltd.
- Study start
- 24 Nov 2011 (actual)
- Primary completion
- 6 Jan 2012 (actual)
- Study completion
- 6 Jan 2012 (actual)
- First posted
- 6 Feb 2020 (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.
Randomized, balanced, incomplete block design exploratory study of efficacy, with 8 active treatments (4 treatments per subject; 35 or 37 subjects per treatment) compared to a reference treatment (all 72 subjects).
Detailed description
Incomplete block design cross over study in which the subjects consumed commercial rice porridge (60 grams of extruded rice to which 300 ml of boiling water was added) in the morning in a fasted state. On each visit one of the seven different natural exacts was mixed into this porridge just before consumption. The reference was consumed by all subjects and consisted of plain porridge with no extract added.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 9
- Model description
- Randomized, balanced, incomplete block design exploratory study of efficacy, with 8 active treatments (4 treatments per subject; 35 or 37 subjects per treatment) compared to a reference treatment (all 72 subjects).
| Arm | Type | Receives |
|---|---|---|
| Mulberry fruit extract | Experimental | Other: Mulberry fruit1.5 g of mulberry fruit powdered extract mixed into a bowl containing 60 g of extruded rice + 300 ml of boiling water |
| Mulberry leaf extract | Experimental | Other: Mulberry leaf1.0 g of mulberry leaf powdered extract mixed into aa bowl containing 60 g of extruded rice + 300 ml of boiling water |
| White bean extract | Experimental | Other: White bean3 g of white bean powdered extract mixed into a bowl containing 60 g of extruded rice + 300 ml of boiling water |
| Apple extract | Experimental | Other: Apple2 g of apple powdered extract standardized in phloridzin mixed into a bowl containing 60 g of extruded rice + 300 ml of boiling water |
| Elderberry extract | Experimental | Other: Elderberry2 g of elderberry powder extract mixed into a bowl containing 60 g of extruded rice + 300 ml of boiling water |
| Turmeric extract | Experimental | Other: Turmeric0.18 g of curcumin powdered extract mixed into a bowl containing 60 g of extruded rice + 300 ml of boiling water |
| Turmeric extract + Apple extract | Experimental | Other: Apple, Other: Turmeric0.18 g of curcumin powdered extract + 2 g of apple powdered extract standardized in phloridzin mixed into a bowl containing 60 g of extruded rice + 300 ml of boiling water |
| Turmeric extract + Elderberry extract | Experimental | Other: Elderberry, Other: Turmeric0.18 g of curcumin powdered extract + 2 g of elderberry powder extract mixed into aa bowl containing 60 g of extruded rice + 300 ml of boiling water |
| Rice porridge control | Placebo comparator | Other: Rice porridgeBowl containing 60 g of extruded rice + 300 ml of boiling water |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Is the volunteer willing to give his consent to participate in the study in writing?
- Is the volunteer between the age of >20 and <50 yrs?
- Is the volunteer's Body Mass Index (BMI) in between >18 and <25 kg/m2?
- Lactase deficient as indicated by screening test1
- Is the volunteer apparently healthy? [No medical conditions which might affect study measurement, as judged by study physician or measured by questionnaire, and/or assessed by haematology, blood chemistry and urinalysis]
Key exclusion criteria (14 listed)
- Is the volunteer an employee of Unilever, Hindustan Lever, or Lambda Therapeutics Research?
- Has the volunteer participated in any other biomedical study 3 months before screening visit day of this study and/or participating in any other biomedical study during the study period?
- Does the volunteer take too much of alcohol (> 120 ml / week)?
- Is the volunteer on a medically prescribed/slimming diet?
- Does the volunteer work in night shifts (between 23.00 and 6.00 hrs) in the week preceding or during the study?
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 fruit | Other | Mulberry fruit extract |
| Mulberry leaf | Other | Mulberry leaf extract |
| White bean | Other | White bean extract |
| Apple | Other | Apple extract, Turmeric extract + Apple extract |
| Elderberry | Other | Elderberry extract, Turmeric extract + Elderberry extract |
| Turmeric | Other | Turmeric extract, Turmeric extract + Apple extract, Turmeric extract + Elderberry extract |
| Rice porridge | Other | Rice porridge control |
Primary outcome
Post-prandial blood glucose
Time frame: Positive incremental Area under the glucose versus time Curve between 0 (before) and 2 hours.
Glucose concentration in venous plasma
3 secondary outcomes
Breath hydrogen excretion
Time frame: Fifteen minutes before (basal) and 65, 125, 185, 245, 305, 365 and 425 minutes after the ingestion of the test products
Intestinal discomfort
Time frame: Ten minutes before (baseline) and at 130, 250, 370 and 420 minutes after the ingestion of the test products.
Stool consistency and number of stools
Time frame: 24 hours before study product intake, during 7 hour the test day and in the 17 hours after the test day (telephone interview).
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 Feb 2020.
- Derived from this study: PubMed 32647531Mela DJ, Cao XZ, Dobriyal R, Fowler MI, Lin L, Joshi M, Mulder TJP, Murray PG, Peters HPF, Vermeer MA, Zhang Z. The effect of 8 plant extracts and combinations on post-prandial blood glucose and insulin responses in healthy adults: a randomized controlled trial. Nutr Metab (Lond). 2020 Jul 6;17:51. doi: 10.1186/s12986-020-00471-x. eCollection 2020.
- Individual participant dataSharing planned: No
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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.
David Mela, Dr. study director
Unilever R&D Vlaardingen (retired)
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 fruit, Mulberry leaf and White bean in people with Blood Glucose, run by Unilever R&D at 1 site in India.
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 11 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 6 Feb 2020. 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 India. 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 blood glucose (time frame: Positive incremental Area under the glucose versus time Curve between 0 (before) and 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 NCT04258501, 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 6 Feb 2020.