Blood GlucoseNCT04256746
Dose Response Study of a Natural Extract for Reducing Post Prandial Blood Glucose
A study testing Boiled Rice, Boiled Rice+0.37 gr mulberry fruit powdered extract and Boiled Rice+0.75 gr mulberry fruit powdered extract in people with Blood Glucose, run by Unilever R&D at 1 site in India.
Trial summary
Randomized, balanced incomplete block design dose response study of efficacy, with 4 different dosages of mulberry fruit powdered extract added to cooked rice compared to a reference treatment (cooked rice only). 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?
- Boiled Rice, Boiled Rice+0.37 gr mulberry fruit powdered extract and Boiled Rice+0.75 gr mulberry fruit powdered extract
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 1 siteIndia
- Study dates
- 24 Sep 2012to 19 Oct 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
- Willing to give consent to participate in the study in writing;
- Healthy male and female subjects between ≥ 20 and ≤ 50.0 years of age;
- BMI of ≥18.0 and ≤ 25.0 kg/m2;
- Apparently healthy: no medical conditions which might effect study measurements as judged by the study physician or measured by questionnaire, and/or assessed by hematology, blood chemistry and urinalysis;
- Willing to comply to study protocol during the study;
- Agreeing to be informed about medically relevant personal test-results by study physician;
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- Willing to refrain from drinking of alcohol on and one day before the blood withdrawal;
- Fasting blood glucose value of volunteer is ≥ 3.4 and ≤ 6.1 mmol/litre (i.e. 62-110 mg/dl) at screening;
- Haemoglobin level within clinically acceptable range (for male 12 to 17 gm/dL and for females 11 to 15 gm / dL; both inclusive) as judged by the research physician.
Who cannot join
- Being an employee of Unilever of Lambda;
- Chronic smokers, tobacco chewers and drinkers;
- Participation in any other biomedical study 3 months before screening visit day of this study and/or participating in any other biomedical study during the screening period;
- High intake of alcohol (>120 mL/week);
- Reported use of medically prescribed/slimming diet;
- Reported participation in night shifts (between 23.00 and 6.00 hrs);
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- Use of medication which interferes with study measurements including vitamins, tonics;
- Reported intense exercise ≥10 h/week;
- Reported weight loss/gain ≥ 10% of body weight in the 6 months preceding screening
- Blood donation for 2 months prior to screening;
- Urine analysis that showed any drug abuse;
- Allergy to any food or cosmetics;
- If female, not being pregnant or planning pregnancy during the study period;
- If female, 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: A Natural Extract for Reducing the Post Prandial Blood Glucose Response in Healthy Indian Adults: A Dose-response Study of Efficacy and Tolerance
Randomized, balanced incomplete block design dose response study of efficacy, with 4 different dosages of mulberry fruit powdered extract added to cooked rice compared to a reference treatment (cooked rice only).
Read the detailed description
Dose response study with 4 dosages of mulberry fruit powdered extract (0.37, 0.75, 1.12 and 1.5 g) added to cooked rice, compared to cooked rice only(reference) on post prandial blood glucose response in healthy Indian adults.
In addition, 1.5 g of mulberry fruit powdered extract was added to instant rice porridge and compared to instant rice porridge only as positive control (replication of previous research.
In total there were 7 test products in the study: 5 active treatments and 2 reference treatments.
The study was a cross-over study (4 interventions per subject, 4 out of the 7 test products). The recovery period between treatments was at least seven days.
- Conditions
- Blood Glucose
- Being tested
- Boiled Rice, Boiled Rice+0.37 gr mulberry fruit powdered extract, Boiled Rice+0.75 gr mulberry fruit powdered extract, Boiled Rice+1.12 gr mulberry fruit powdered extract, Boiled Rice+1.50 gr mulberry fruit powdered extract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Boiled RiceOther
Boiled Rice+0.37 gr mulberry fruit powdered extractOther
Boiled Rice+0.75 gr mulberry fruit powdered extractOther
Boiled Rice+1.12 gr mulberry fruit powdered extractOther
Boiled Rice+1.50 gr mulberry fruit powdered extractOther
Rice PorridgeOther
Rice porridge+1.50 gr mulberry fruit powdered extractOther
| Study group | Role | What they receive |
|---|---|---|
| Boiled Rice | Placebo comparator | 63 g of raw rice was cooked. Receives: Other: Boiled Rice |
| Boiled Rice+0.37 gr extract | Experimental | 63 g of raw rice was cooked and 0.37 gr mulberry fruit powdered extract added and mixed Receives: Other: Boiled Rice+0.37 gr mulberry fruit powdered extract |
| Boiled Rice+0.75 gr extract | Experimental | 63 g of raw rice was cooked and 0.75 gr mulberry fruit powdered extract added and mixed Receives: Other: Boiled Rice+0.75 gr mulberry fruit powdered extract |
| Boiled Rice+1.12 gr extract | Experimental | 63 g of raw rice was cooked and 1.12 gr mulberry fruit powdered extract added and mixed Receives: Other: Boiled Rice+1.12 gr mulberry fruit powdered extract |
| Boiled Rice+1.50 gr extract | Experimental | 63 g of raw rice was cooked and 1.50 gr mulberry fruit powdered extract added and mixed Receives: Other: Boiled Rice+1.50 gr mulberry fruit powdered extract |
| Rice porridge | Placebo comparator | 60 g of rice porridge was rehydrated with 300 ml boiling hot water Receives: Other: Rice Porridge |
| Rice porridge+1.50 gr extract | Active comparator | 60 g of rice porridge was rehydrated with 300 ml boiling hot water and 1.50 gr mulberry fruit powdered extract added and mixed Receives: Other: Rice porridge+1.50 gr mulberry fruit powdered extract |
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 after test product intake
Secondary outcomes (1)
Post-prandial insulin
Post-prandial serum insulin
Measured: Total area under the insulin versus time curves between 0 (before) and 2 hours after study product intake
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start24 Sep 2012
- Primary completion19 Oct 2012
- Study completion19 Oct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 dose response study of efficacy,
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 84 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
- NCT04256746
- Sponsor's protocol ID
- FDS-NAA-0720
- Status last verified
- Feb 2020
- First submitted
- 31 Jan 2020
- Last updated
- 5 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Natural Extract for Reducing the Post Prandial Blood Glucose Response in Healthy Indian Adults: A Dose-response Study of Efficacy and Tolerance
- ClinicalTrials.gov ID
- NCT04256746
- Acronym / sponsor ID
- FDS-NAA-0720
- Conditions
- Blood Glucose
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Unilever R&DIndustry (pharma, biotech, devices)
- Collaborators
- Lambda Therapeutic Research Ltd.
- Study start
- 24 Sep 2012 (actual)
- Primary completion
- 19 Oct 2012 (actual)
- Study completion
- 19 Oct 2012 (actual)
- First posted
- 5 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 dose response study of efficacy, with 4 different dosages of mulberry fruit powdered extract added to cooked rice compared to a reference treatment (cooked rice only).
Detailed description
Dose response study with 4 dosages of mulberry fruit powdered extract (0.37, 0.75, 1.12 and 1.5 g) added to cooked rice, compared to cooked rice only(reference) on post prandial blood glucose response in healthy Indian adults.
In addition, 1.5 g of mulberry fruit powdered extract was added to instant rice porridge and compared to instant rice porridge only as positive control (replication of previous research.
In total there were 7 test products in the study: 5 active treatments and 2 reference treatments.
The study was a cross-over study (4 interventions per subject, 4 out of the 7 test products). The recovery period between treatments was at least seven days.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 7
- Model description
- Randomized, balanced incomplete block design dose response study of efficacy,
| Arm | Type | Receives |
|---|---|---|
| Boiled Rice | Placebo comparator | Other: Boiled Rice63 g of raw rice was cooked. |
| Boiled Rice+0.37 gr extract | Experimental | Other: Boiled Rice+0.37 gr mulberry fruit powdered extract63 g of raw rice was cooked and 0.37 gr mulberry fruit powdered extract added and mixed |
| Boiled Rice+0.75 gr extract | Experimental | Other: Boiled Rice+0.75 gr mulberry fruit powdered extract63 g of raw rice was cooked and 0.75 gr mulberry fruit powdered extract added and mixed |
| Boiled Rice+1.12 gr extract | Experimental | Other: Boiled Rice+1.12 gr mulberry fruit powdered extract63 g of raw rice was cooked and 1.12 gr mulberry fruit powdered extract added and mixed |
| Boiled Rice+1.50 gr extract | Experimental | Other: Boiled Rice+1.50 gr mulberry fruit powdered extract63 g of raw rice was cooked and 1.50 gr mulberry fruit powdered extract added and mixed |
| Rice porridge | Placebo comparator | Other: Rice Porridge60 g of rice porridge was rehydrated with 300 ml boiling hot water |
| Rice porridge+1.50 gr extract | Active comparator | Other: Rice porridge+1.50 gr mulberry fruit powdered extract60 g of rice porridge was rehydrated with 300 ml boiling hot water and 1.50 gr mulberry fruit powdered extract added and mixed |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Willing to give consent to participate in the study in writing;
- Healthy male and female subjects between ≥ 20 and ≤ 50.0 years of age;
- BMI of ≥18.0 and ≤ 25.0 kg/m2;
- Apparently healthy: no medical conditions which might effect study measurements as judged by the study physician or measured by questionnaire, and/or assessed by hematology, blood chemistry and urinalysis;
- Willing to comply to study protocol during the study;
Key exclusion criteria (14 listed)
- Being an employee of Unilever of Lambda;
- Chronic smokers, tobacco chewers and drinkers;
- Participation in any other biomedical study 3 months before screening visit day of this study and/or participating in any other biomedical study during the screening period;
- High intake of alcohol (>120 mL/week);
- Reported use of medically prescribed/slimming diet;
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 |
|---|---|---|
| Boiled Rice | Other | Boiled Rice |
| Boiled Rice+0.37 gr mulberry fruit powdered extract | Other | Boiled Rice+0.37 gr extract |
| Boiled Rice+0.75 gr mulberry fruit powdered extract | Other | Boiled Rice+0.75 gr extract |
| Boiled Rice+1.12 gr mulberry fruit powdered extract | Other | Boiled Rice+1.12 gr extract |
| Boiled Rice+1.50 gr mulberry fruit powdered extract | Other | Boiled Rice+1.50 gr extract |
| Rice Porridge | Other | Rice porridge |
| Rice porridge+1.50 gr mulberry fruit powdered extract | Other | Rice porridge+1.50 gr extract |
Primary outcome
Post-prandial blood glucose
Time frame: Positive incremental Area under the glucose versus time Curve between 0 (before) and 2 hours after test product intake
Glucose concentration in venous plasma
1 secondary outcome
Post-prandial insulin
Time frame: Total area under the insulin versus time curves between 0 (before) and 2 hours after study product intake
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 5 Feb 2020.
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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 Boiled Rice, Boiled Rice+0.37 gr mulberry fruit powdered extract and Boiled Rice+0.75 gr mulberry fruit powdered extract 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 9 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 5 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 after test product intake). 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 5 Feb 2020.