PreDiabetesNCT06417840
To Evaluate the Impact of Consumption of a Bioactive Compound on Fasting Blood Glucose Levels in Asian Indians With Pre-diabetes
A study testing N-trans-caffeoyltyramine (NCT) and N-trans-feruloyltyramine (NFT) in people with PreDiabetes, run by Brightseed at 1 site in India.
Trial summary
This is randomized placebo controlled, double-blinded, parallel arm study on free living Asian Indians. Eligible subjects will undergo one-week run-in period and subjects will be asked to maintain their usual diet and exercise regime. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- PreDiabetes
- What is being tested?
- N-trans-caffeoyltyramine (NCT) and N-trans-feruloyltyramine (NFT)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 130 participants
- Where
- 1 siteIndia
- Study dates
- 22 Jun 2024to 30 Oct 2024
- 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
- Fasting Blood Glucose between 100-125 mg/dL;
- and BMI range 25-30 kg/m2;
- and waist circumference ≥80cm for women and ≥90cm for men;
Who cannot join
- Weight loss or gain ≥4.5 kg within 90 days of visit 1.
- Use of weight loss medications within 90 days of visit 1.
- History of gastrointestinal surgery (e.g., bariatric surgery) or cosmetic procedures (e.g., liposuction) for weight/fat reducing purposes.
- Use of dietary supplements or related products that, in the judgment of the Investigator, are likely to markedly affect weight loss or appetite within 30 days of visit 1.
- History of extreme dietary habits (e.g., Atkins diet, etc.), as judged by the Investigator.
- History of an eating disorder (e.g., anorexia nervosa, bulimia nervosa, or binge eating) diagnosed by a health professional.
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- Current medical diagnosis of type 1 or type 2 diabetes mellitus.
- HbA1c ≥48 mmol/mol (6.5%) as measured at visit 1.
- History of a chronic gastrointestinal disorder, such as peptic ulcer disease or malabsorption syndrome (mild lactose intolerance or gastroesophageal reflux diseases are acceptable).
- Signs or symptoms of an active infection of clinical relevance within 5 days of visit 1. The visit may be rescheduled such that all signs and symptoms have resolved (at the discretion of the Clinical Investigator) at least 5 days prior to visit 1.
- Is pregnant, planning to be pregnant during the study period, lactating, or is of childbearing potential and is unwilling to commit to the use of a medically approved form of contraception throughout the study period. The method of contraception must be recorded in the source document.
- Any condition the Investigator believes would interfere with his or her ability to provide informed consent, comply with the study protocol, or which might confound the interpretation of the study results or put the person at undue risk.
- Excessive alcohol consumption (> 2 Drinks, 60 ml of Whisky Per Day).
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
Diabetes Foundation (India)
New Delhi, 110 016
Anoop Misra, PhD, 91-11-41759672, anoopmisra@gmail.com
About this study
Official title: To Evaluate the Impact of Consumption of a Bioactive Compound Extracted From Fermented Yeast on Fasting Blood Glucose Levels in Asian Indians With Pre-diabetes: A Randomized, Double Blinded, Placebo-controlled Parallel Arm Trial
This is randomized placebo controlled, double-blinded, parallel arm study on free living Asian Indians. Eligible subjects will undergo one-week run-in period and subjects will be asked to maintain their usual diet and exercise regime. At the end of the run-in period, subjects fulfilling the inclusion/exclusion criteria at this stage will be randomized either to the intervention arm or control arm using computerized random number tables.
The measured parameters will include, 24-h diet recall, food frequency questionnaire, anthropometry including circumferences, height and weight, and blood parameters including blood glucose (fasting), serum insulin (fasting), HbA1c and lipid profile.
- Conditions
- PreDiabetes
- Being tested
- N-trans-caffeoyltyramine (NCT) and N-trans-feruloyltyramine (NFT), Placebo Control
- Medical subject headings
- Prediabetic State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
N-trans-caffeoyltyramine (NCT) and N-trans-feruloyltyramine (NFT)Dietary supplement
N-trans-caffeoyltyramine (NCT) and N-trans-feruloyltyramine (NFT) derived via synthetic biology (i.e., fermentation using a recombinant microorganism) to provide a high purity (>85%) form of these compounds that are structurally identical to their naturally occurring counterparts. All ingredients in the encapsulated final test article, including the NCT and NFT, are manufactured under food GMPs and are of suitable quality for use in food, dietary supplements, and specialty nutrition products.
Placebo ControlDietary supplement
Placebo Control
| Study group | Role | What they receive |
|---|---|---|
| Placebo Control | Placebo comparator | Not described Receives: Dietary Supplement: Placebo Control |
| N-trans-caffeoyltyramine (NCT) and N-trans-feruloyltyramine (NFT) | Experimental | Not described Receives: Dietary Supplement: N-trans-caffeoyltyramine (NCT) and N-trans-feruloyltyramine (NFT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fasting Blood Glucose
Blood Glucose Concentration mg/dL
Measured: 0, and 28 days
Secondary outcomes (11)
Fasting Blood Insulin
Blood Insulin Concentration mcIU/mL
Measured: 0, and 28 days
HbA1c
Percent (%) blood HbA1c level
Measured: 0, and 28 days
Continuous Glucose Monitoring
Continuous Blood Glucose Monitoring mg/dL
Measured: 0, and 28 days
Total Cholesterol
Total blood cholesterol mg/dL
Measured: 0, and 28 days
Low-density lipoprotein (LDL) cholesterol
Blood Low-density lipoprotein (LDL) cholesterol mg/dL
Measured: 0, and 28 days
High-density lipoprotein (HDL) cholesterol
Blood High-density lipoprotein (HDL) cholesterol mg/dL
Measured: 0, and 28 days
Triglycerides
Blood Triglycerides mg/dL
Measured: 0, and 28 days
Weight
kg of Body Weight
Measured: 0, and 28 days
Height
Height in meters (m)
Measured: 0, and 28 days
Body Mass Index (BMI)
Body mass index (BMI) measured via weight in kilograms divided by the square of height in meters.
Measured: 0, and 28 days
Waist Circumference
Waist Circumference in cm
Measured: 0, and 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2024
- Study start22 Jun 2024
- Primary completion30 Oct 2024 (estimated)
- Study completion30 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PreDiabetesStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brightseed
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06417840
- Sponsor's protocol ID
- 1.4/FCDOC/EC/HAO/2024-25
- Status last verified
- Jul 2024
- First submitted
- 13 May 2024
- Last updated
- 24 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Evaluate the Impact of Consumption of a Bioactive Compound Extracted From Fermented Yeast on Fasting Blood Glucose Levels in Asian Indians With Pre-diabetes: A Randomized, Double Blinded, Placebo-controlled Parallel Arm Trial
- ClinicalTrials.gov ID
- NCT06417840
- Acronym / sponsor ID
- 1.4/FCDOC/EC/HAO/2024-25
- Conditions
- PreDiabetes
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- BrightseedIndustry (pharma, biotech, devices)
- Study start
- 22 Jun 2024 (actual)
- Primary completion
- 30 Oct 2024 (estimated)
- Study completion
- 30 Oct 2024 (estimated)
- First posted
- 16 May 2024 (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.
This is randomized placebo controlled, double-blinded, parallel arm study on free living Asian Indians. Eligible subjects will undergo one-week run-in period and subjects will be asked to maintain their usual diet and exercise regime. At the end of the run-in period, subjects fulfilling the inclusion/exclusion criteria at this stage will be randomized either to the intervention arm or control arm using computerized random number tables.
The measured parameters will include, 24-h diet recall, food frequency questionnaire, anthropometry including circumferences, height and weight, and blood parameters including blood glucose (fasting), serum insulin (fasting), HbA1c and lipid profile.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo Control | Placebo comparator | Dietary Supplement: Placebo Control |
| N-trans-caffeoyltyramine (NCT) and N-trans-feruloyltyramine (NFT) | Experimental | Dietary Supplement: N-trans-caffeoyltyramine (NCT) and N-trans-feruloyltyramine (NFT) |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Fasting Blood Glucose between 100-125 mg/dL;
- and BMI range 25-30 kg/m2;
- and waist circumference ≥80cm for women and ≥90cm for men;
Key exclusion criteria (13 listed)
- Weight loss or gain ≥4.5 kg within 90 days of visit 1.
- Use of weight loss medications within 90 days of visit 1.
- History of gastrointestinal surgery (e.g., bariatric surgery) or cosmetic procedures (e.g., liposuction) for weight/fat reducing purposes.
- Use of dietary supplements or related products that, in the judgment of the Investigator, are likely to markedly affect weight loss or appetite within 30 days of visit 1.
- History of extreme dietary habits (e.g., Atkins diet, etc.), as judged by the Investigator.
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 |
|---|---|---|
| N-trans-caffeoyltyramine (NCT) and N-trans-feruloyltyramine (NFT)N-trans-caffeoyltyramine (NCT) and N-trans-feruloyltyramine (NFT) derived via synthetic biology (i.e., fermentation using a recombinant microorganism) to provide a high purity (>85%) form of these compounds that are structurally identical to their naturally occurring counterparts. All ingredients in the encapsulated final test article, including the NCT and NFT, are manufactured under food GMPs and are of suitable quality for use in food, dietary supplements, and specialty nutrition products. | Dietary supplement | N-trans-caffeoyltyramine (NCT) and N-trans-feruloyltyramine (NFT) |
| Placebo ControlPlacebo Control | Dietary supplement | Placebo Control |
Primary outcome
Fasting Blood Glucose
Time frame: 0, and 28 days
Blood Glucose Concentration mg/dL
11 secondary outcomes
Fasting Blood Insulin
Time frame: 0, and 28 days
HbA1c
Time frame: 0, and 28 days
Continuous Glucose Monitoring
Time frame: 0, and 28 days
Total Cholesterol
Time frame: 0, and 28 days
Low-density lipoprotein (LDL) cholesterol
Time frame: 0, and 28 days
High-density lipoprotein (HDL) cholesterol
Time frame: 0, and 28 days
Triglycerides
Time frame: 0, and 28 days
Weight
Time frame: 0, and 28 days
Height
Time frame: 0, and 28 days
Body Mass Index (BMI)
Time frame: 0, and 28 days
Waist Circumference
Time frame: 0, and 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing N-trans-caffeoyltyramine (NCT) and N-trans-feruloyltyramine (NFT) in people with PreDiabetes, run by Brightseed 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 3 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 24 Jul 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anoop Misra, PhD (91-11-41759672, anoopmisra@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fasting Blood Glucose (time frame: 0, and 28 days). 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 24 Jul 2024.