InterventionPhase 3NCT06454773
To Evaluate the Impact of Consumption of Bioactive Compounds Extracted From Hemp Hull and Black Pepper on Fasting Blood Glucose Levels in People With Pre-diabetes: A Randomized Placebo-Controlled Parallel Arm Trial
A Phase 3 study testing NCT/NFT in people with Intervention, run by Diabetes Foundation, India at 1 site in India.
Trial summary
This is randomized controlled 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 25 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Intervention
- What is being tested?
- NCT/NFT
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 130 participants
- Where
- 1 siteIndia
- Study dates
- 1 Jun 2024to 31 Dec 2024
- Phase
- Phase 3
- 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 25 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Prediabetic individuals of BMI range 25-30 kg/m2 and waist circumference ≥80cm for women and ≥90cm for men with Fasting Blood Glucose between 100-125 mg/dL.
Who cannot join
- Prediabetic individuals of BMI range 25-30 kg/m2 and waist circumference ≥80cm for women and ≥90cm for men with Fasting Blood Glucose between 100-125 mg/dL.
- 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.
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- History of an eating disorder (e.g., anorexia nervosa, bulimia nervosa, or binge eating) diagnosed by a health professional.
- 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
National Diabetes, obesity and cholesterol foundation (NDOC)
Delhi, 110016
Seema Gulati, 09312069151, seemagulati2007@gmail.com
About this study
This is randomized controlled 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.
Read the detailed description
To study the impact of bioactive compound supplementation on fasting blood glucose.
To study the impact of intervention with bioactive compound on following measures of glycaemia:
- 24 hr AUC total from CGM Post-prandial glucose regulation
- iAUC determined from CGM readout up to 2 hr after consumption of a Standard Meal Blood Chemistry
- Fasting Insulin
- HbA1c
- Lipid profile Anthropometry
- Weight
- BMI
- Waist Circumference
- Conditions
- Intervention
- Being tested
- NCT/NFT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NCT/NFTDietary supplement
extract from black pepper and hemp hull
| Study group | Role | What they receive |
|---|---|---|
| intervention | Active comparator | bioactive compound from black pepper and hemp hull Receives: Dietary Supplement: NCT/NFT |
| control | Placebo comparator | Placebo Receives: Dietary Supplement: NCT/NFT |
What is being measured
The primary outcome is the main question the study is designed to answer.
fasting blood glucose
Measured: 30 days
Secondary outcomes (1)
Body weight
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2024
- Study start1 Jun 2024
- Primary completion1 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InterventionStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- double-blind placebo controlled
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Diabetes Foundation, India
- Sponsor type
- University, hospital or other
- Collaborators
- Brightseed
- Responsible party
- Principal investigator, Dr Anoop Misra, Diabetes Foundation, India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06454773
- Sponsor's protocol ID
- F.No 1.4 FCDOC/EC/HAO/2024-25
- Status last verified
- Jun 2024
- First submitted
- 6 Jun 2024
- Last updated
- 12 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Evaluate the Impact of Consumption of Bioactive Compounds Extracted From Hemp Hull and Black Pepper on Fasting Blood Glucose Levels in People With Pre-diabetes: A Randomized Placebo-Controlled Parallel Arm Trial
- ClinicalTrials.gov ID
- NCT06454773
- Acronym / sponsor ID
- F.No 1.4 FCDOC/EC/HAO/2024-25
- Conditions
- Intervention
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Diabetes Foundation, IndiaUniversity, hospital or other
- Collaborators
- Brightseed
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 12 Jun 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 controlled 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.
Detailed description
To study the impact of bioactive compound supplementation on fasting blood glucose.
To study the impact of intervention with bioactive compound on following measures of glycaemia:
- 24 hr AUC total from CGM Post-prandial glucose regulation
- iAUC determined from CGM readout up to 2 hr after consumption of a Standard Meal Blood Chemistry
- Fasting Insulin
- HbA1c
- Lipid profile Anthropometry
- Weight
- BMI
- Waist Circumference
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- double-blind placebo controlled
| Arm | Type | Receives |
|---|---|---|
| intervention | Active comparator | Dietary Supplement: NCT/NFTbioactive compound from black pepper and hemp hull |
| control | Placebo comparator | Dietary Supplement: NCT/NFTPlacebo |
Who may qualify
- Ages
- 25 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Prediabetic individuals of BMI range 25-30 kg/m2 and waist circumference ≥80cm for women and ≥90cm for men with Fasting Blood Glucose between 100-125 mg/dL.
Key exclusion criteria (14 listed)
- Prediabetic individuals of BMI range 25-30 kg/m2 and waist circumference ≥80cm for women and ≥90cm for men with Fasting Blood Glucose between 100-125 mg/dL.
- 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.
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 |
|---|---|---|
| NCT/NFTextract from black pepper and hemp hull | Dietary supplement | control, intervention |
Primary outcome
fasting blood glucose
Time frame: 30 days
1 secondary outcome
Body weight
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 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 Phase 3 study testing NCT/NFT in people with Intervention, run by Diabetes Foundation, India 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 1 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: status not confirmed, as of the sponsor's last update on 12 Jun 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 (49101222, 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: 30 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 12 Jun 2024.