DiabetesDiabetesNCT06645002
Effect of Stevia Leave Powder on Blood Glucose and Lipid Profile of Diabetic Patients
A study testing stevia rebaudiana bertoni in people with Diabetes, run by University of Lahore at 1 site in Pakistan.
Trial summary
The goal of this clinical trial is to know if stevia leave powder capsule (1000 mg/day) will work to treat diabetes in participants. The main objectives it aims to answer are: Does stevia decrease the blood glucose level in diabetic subjects that will use stevia powder capsule? Does stevia play its role in blood lipid… Read more about this study
- Who is it for?
- Ages 25 to 35 years
- Conditions the study is for
- Diabetes
- What is being tested?
- stevia rebaudiana bertoni
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 1 sitePakistan
- Study dates
- 22 Aug 2024to 22 Feb 2025
- 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 25 to 35 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Inclusion Criteria: Individuals with the following conditions will be included as participants;
- Patients of type 2 diabetes mellitus with the age range between 25-35 years from both genders
- Diabetic patients without anti-diabetic drugs and their duration of diabetes no longer than 6 months
- Diabetic patients with HbA1c \>6% and blood sugar level \>200 mg/dL
Who cannot join
- Individuals with the following conditions were not included as participants;
- Patients with nephropathy, retinopathy, diabetic foot, phenylketonuria, maple syrup urine disease
- Participants with acute and chronic kidney disease, kidney stone,
- Participants with history of acute liver injury (e.g., hepatitis) or severe cirrhosis
- Diabetic patients with obesity, cardiovascular diseases, pregnancy
- Participants taking nutritional supplements and other medicines
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Short and Long-Term Treatment of Stevia Leave Powder on Blood Glucose and Lipid Profile of Diabetic Patients.
The goal of this clinical trial is to know if stevia leave powder capsule (1000 mg/day) will work to treat diabetes in participants. The main objectives it aims to answer are:
Does stevia decrease the blood glucose level in diabetic subjects that will use stevia powder capsule? Does stevia play its role in blood lipid profile in diabetic subjects that will use stevia powder capsule? The purpose of the study to see the impact of stevia in short (7 days) and long-term treatments (60 days) in diabetic subjects and compare the results
Read more
Diabetic subjects will:
Take stevia powder capsule every day for 7 days in short term study Take stevia powder capsule every day for 60 days in long term study
Check the biochemical assessment including blood glucose and lipid profile tests at 0 and 7th days in short term study Check the biochemical assessment including blood glucose and lipid profile tests at 0 and 30 and 60th days in long term study Keep a record of all the tests for comparison
Read the detailed description
The selected participants will be randomly divided into placebo and treatment groups. The Initial (0-Day) data on anthropometric measurements and blood analysis on glucose, lipid levels and liver function tests (LFTs) will be carried out.
The balance diet plan will be prepared according to Pakistan dietary guidelines and given to all the study participants. Treatment stevia powder capsules will be provided to the participants for 7 days and for 60 days for short and long-term study respectively, for monitoring of compliance. Anthropometric measurements and biochemical assessments like blood glucose levels, lipid profile, insulin resistance and LFTs for short-term study will be measured at baseline, 7th and 60th day while, measurements of blood glucose, lipid profile, insulin resistance and LFTs will be carried out a baseline, 30, and 60 days for long-term study. In this research we will be analysed the effect of stevia powder capsules on diabetic patients for short and long term study.
- Conditions
- Diabetes
- Being tested
- stevia rebaudiana bertoni
- Keywords
- Diabetes, Stevia, Glucose, Lipid profile
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
stevia rebaudiana bertoniDietary supplement
effect of short term study (7 days) of stevia leave powder 1000 mg/day in diabetic subjects
stevia rebaudiana bertoniDietary supplement
effect of long term study (60 days) of stevia leave powder 1000 mg/day in diabetic subjects
| Study group | Role | What they receive |
|---|---|---|
| short term study | Experimental | short term study (7 days) stevia leave powder 1000 mg/day Receives: Dietary Supplement: stevia rebaudiana bertoni |
| long term study | Experimental | Long term study (60 days) stevia leave powder 1000 mg/day Receives: Dietary Supplement: stevia rebaudiana bertoni |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the effects of short and long-term treatment of stevia powder capsules on blood glucose levels among diabetic patients
Teatment group respondents of short term study will be received the stevia powder capsules of 1000mg for 7 days, this group includes the initial screening and assessment of subjects suffering from type-II diabetes. The subjects will also being studied for medical history and anthropometric parameters which include height and weight, BMI and biochemical parameters which include blood glucose levels of fasting, post-prandial, insulin resistance and HbA1c In addition, a dietary study will also be done by food diary method on 3 alternative days. The biochemical parameters of the subjects will be measured at 0, 7th and at 60th day.
Long-term treatment group participants will receive the treatment with 1000mg stevia powder in capsulated form once per day for 60 days, this group will also undergo the initial screening and assessment of anthropometric and biochemical parameters at 0, 30th and 60th day then will perform comparison analysis at 60th day for both short and long-term studies.
Measured: Short term study (7 days) long term study (60 days)
Secondary outcomes (1)
To compare the effects of short and long-term treatment of stevia powder capsules on lipid profile and LFTs among diabetic patients
Treatment group respondents of short term study will be received the stevia powder capsules of 1000mg for 7 days, After initial assessment, BMI and blood glucose levels record, the lipid profile including, cholesterol, HDL, LDL and LFTs including ALT, AST will also be measured 0, 7th and at 60th day. Same tests will also be performed on long-term study participants and will measure the results at 0, 30 and 60th day of the study, then will perform comparison analysis at 60th day for both short and long-term studies.
Measured: Short term study (7 days) long term study (60 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2024
- Study start22 Aug 2024
- Primary completion22 Nov 2024 (estimated)
- Study completion22 Feb 2025 (estimated)
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 DiabetesStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Lahore
- Sponsor type
- University, hospital or other
- Collaborators
- Allied Hospital Faisalabad
- Responsible party
- Principal investigator, Fasiha Ahsan, University of Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06645002
- Sponsor's protocol ID
- IRB-UOL-FAHS/774/2020
- Acronym
- Diabetes
- Status last verified
- Sep 2024
- First submitted
- 27 Sep 2024
- Last updated
- 16 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Primary reason for not sharing the IPD is to protect participants privacy
Publications
Ritu M, Nandini J. Nutritional composition of Stevia rebaudiana, a sweet herb, and its hypoglycaemic and hypolipidaemic effect on patients with non-insulin dependent diabetes mellitus. J Sci Food Agric. 2016 Sep;96(12):4231-4. doi: 10.1002/jsfa.7627. Epub 2016 Feb 22.
PubMed 26781312
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Short and Long-Term Treatment of Stevia Leave Powder on Blood Glucose and Lipid Profile of Diabetic Patients.
- ClinicalTrials.gov ID
- NCT06645002
- Acronym / sponsor ID
- Diabetes / IRB-UOL-FAHS/774/2020
- Conditions
- Diabetes
- Keywords
- Diabetes, Stevia, Glucose, Lipid profile
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- University of LahoreUniversity, hospital or other
- Collaborators
- Allied Hospital Faisalabad
- Study start
- 22 Aug 2024 (actual)
- Primary completion
- 22 Nov 2024 (estimated)
- Study completion
- 22 Feb 2025 (estimated)
- First posted
- 16 Oct 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.
The goal of this clinical trial is to know if stevia leave powder capsule (1000 mg/day) will work to treat diabetes in participants. The main objectives it aims to answer are:
Does stevia decrease the blood glucose level in diabetic subjects that will use stevia powder capsule? Does stevia play its role in blood lipid profile in diabetic subjects that will use stevia powder capsule? The purpose of the study to see the impact of stevia in short (7 days) and long-term treatments (60 days) in diabetic subjects and compare the results
Diabetic subjects will:
Take stevia powder capsule every day for 7 days in short term study Take stevia powder capsule every day for 60 days in long term study
Check the biochemical assessment including blood glucose and lipid profile tests at 0 and 7th days in short term study Check the biochemical assessment including blood glucose and lipid profile tests at 0 and 30 and 60th days in long term study Keep a record of all the tests for comparison
Detailed description
The selected participants will be randomly divided into placebo and treatment groups. The Initial (0-Day) data on anthropometric measurements and blood analysis on glucose, lipid levels and liver function tests (LFTs) will be carried out.
The balance diet plan will be prepared according to Pakistan dietary guidelines and given to all the study participants. Treatment stevia powder capsules will be provided to the participants for 7 days and for 60 days for short and long-term study respectively, for monitoring of compliance. Anthropometric measurements and biochemical assessments like blood glucose levels, lipid profile, insulin resistance and LFTs for short-term study will be measured at baseline, 7th and 60th day while, measurements of blood glucose, lipid profile, insulin resistance and LFTs will be carried out a baseline, 30, and 60 days for long-term study. In this research we will be analysed the effect of stevia powder capsules on diabetic patients for short and long term study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| short term study | Experimental | Dietary Supplement: stevia rebaudiana bertonishort term study (7 days) stevia leave powder 1000 mg/day |
| long term study | Experimental | Dietary Supplement: stevia rebaudiana bertoniLong term study (60 days) stevia leave powder 1000 mg/day |
Who may qualify
- Ages
- 25 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Inclusion Criteria: Individuals with the following conditions will be included as participants;
- Patients of type 2 diabetes mellitus with the age range between 25-35 years from both genders
- Diabetic patients without anti-diabetic drugs and their duration of diabetes no longer than 6 months
- Diabetic patients with HbA1c \>6% and blood sugar level \>200 mg/dL
Key exclusion criteria (6 listed)
- Individuals with the following conditions were not included as participants;
- Patients with nephropathy, retinopathy, diabetic foot, phenylketonuria, maple syrup urine disease
- Participants with acute and chronic kidney disease, kidney stone,
- Participants with history of acute liver injury (e.g., hepatitis) or severe cirrhosis
- Diabetic patients with obesity, cardiovascular diseases, pregnancy
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 |
|---|---|---|
| stevia rebaudiana bertonieffect of short term study (7 days) of stevia leave powder 1000 mg/day in diabetic subjects | Dietary supplement | long term study, short term study |
| stevia rebaudiana bertonieffect of long term study (60 days) of stevia leave powder 1000 mg/day in diabetic subjects | Dietary supplement | long term study |
Primary outcome
To compare the effects of short and long-term treatment of stevia powder capsules on blood glucose levels among diabetic patients
Time frame: Short term study (7 days) long term study (60 days)
Teatment group respondents of short term study will be received the stevia powder capsules of 1000mg for 7 days, this group includes the initial screening and assessment of subjects suffering from type-II diabetes. The subjects will also being studied for medical history and anthropometric parameters which include height and weight, BMI and biochemical parameters which include blood glucose levels of fasting, post-prandial, insulin resistance and HbA1c In addition, a dietary study will also be done by food diary method on 3 alternative days. The biochemical parameters of the subjects will be measured at 0, 7th and at 60th day. Long-term treatment group participants will receive the treatment with 1000mg stevia powder in capsulated form once per day for 60 days, this group will also undergo the initial screening and assessment of anthropometric and biochemical parameters at 0, 30th and 60th day then will perform comparison analysis at 60th day for both short and long-term studies.
1 secondary outcome
To compare the effects of short and long-term treatment of stevia powder capsules on lipid profile and LFTs among diabetic patients
Time frame: Short term study (7 days) long term study (60 days)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2024.
- Background: PubMed 26781312Ritu M, Nandini J. Nutritional composition of Stevia rebaudiana, a sweet herb, and its hypoglycaemic and hypolipidaemic effect on patients with non-insulin dependent diabetes mellitus. J Sci Food Agric. 2016 Sep;96(12):4231-4. doi: 10.1002/jsfa.7627. Epub 2016 Feb 22.
- Individual participant dataSharing planned: No. Primary reason for not sharing the IPD is to protect participants privacy
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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 stevia rebaudiana bertoni in people with Diabetes, run by University of Lahore at 1 site in Pakistan.
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 4 inclusion and 6 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 16 Oct 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 Pakistan. 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. 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?
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?
To compare the effects of short and long-term treatment of stevia powder capsules on blood glucose levels among diabetic patients (time frame: Short term study (7 days) long term study (60 days)). 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 NCT06645002, 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 16 Oct 2024.