NormoglycemiaNCT06055582
To Study the Effects of Mango Ingestion in T2DM and Non-diabetic Subjects.
A study testing Bread and Mango in people with Normoglycemia and T2DM (Type 2 Diabetes Mellitus), run by Diabetes Foundation, India at 1 site in India.
Trial summary
T2DM patient will be recruited from endocrine OPD 1. Clinical History and Examination: 1. General Physical Examination: Height (cm) weight (kg) BMI (kg/m2) Blood Pressure (mmHg) 2. Anthropometry: Circumferences and skinfold thickness will be recorded for the patients in the following manner. Read more about this study
- Who is it for?
- Ages 25 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Normoglycemia, T2DM (Type 2 Diabetes Mellitus)
- What is being tested?
- Bread and Mango
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteIndia
- Study dates
- 11 Feb 2022to 1 Mar 2023
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- -For patients with diabetes: Stable glycemic control on metformin or sulfonylurea for past 3 months and without any major complications and HbA1C less than 8%
Who cannot join
- Acute infections and advanced end-organ damage
- History of hepatitis or pancreatitis, abnormal liver and renal functions
- Recent (<3 months) changes in weight
- Any known allergy to mangoes and bread
- Subjects with hypothyroidism
- On any drug causing weight gain or weight loss.
Trial locations and contacts
1 site in 1 country.
India1 site
Fortis CDOC Hospital
New Delhi, National Capital Territory of Delhi, 110048
About this study
Official title: A Randomized Controlled Study to Compare Effects of Mango Ingestion on Glycemia (Glycemic Response, Continuous Glucose Monitoring and Fructosamine) Insulin Resistance and Body Composition in Patients With T2DM and Non-diabetic Subjects.
T2DM patient will be recruited from endocrine OPD
- Clinical History and Examination:
- General Physical Examination:
Read more
- Height (cm)
- weight (kg)
- BMI (kg/m2)
- Blood Pressure (mmHg)
- Anthropometry: Circumferences and skinfold thickness will be recorded for the patients in the following manner. Circumferences:
- Waist circumference (cm)
- Hip circumference (cm)
- Mid-arm circumference (cm)
- Mid-thigh circumference (cm)
- Skin fold thickness: Skin fold thickness will be measured by using (LANGE skin fold calipers) (to nearest of 1 mm) at the following sites
- Biceps (mm)
- Triceps (mm)
- Thigh (mm)
- Calf (mm)
- Sub scapular (mm)
- Supra-iliac (mm)
- Anterior axillary fold. (mm)
- Biochemical Test: The biochemical analysis will be done using ELISA kit or commercially available kits
- Blood glucose (mg/dL)
- HbA1c (%)
- Serum insulin (μIU/mL)
- Total Cholestrol (mg/dl)
- Triglyceride (mg/dl)
- Fructosamine (umol/L)
- Adiponectin (µg/ml) -- HOMA-IR
- Body Composition Analysis (TANITA)
Read the detailed description
- Phase I: Exploratory Acute Phase- Stratified randomized study
- Study population: 2 groups; patients with T2DM and non-diabetic subjects n=45 (20 T2DM subject, 25 non-diabetic subjects).
- Study groups: 3 groups; OGTT (n=5), mango (n=30), bread (n=10) Subjects in mango group will be further randomized into three different groups. Each group will be tested on a different variety of mango. Procedure for Phase I: After measuring baseline glucose level on empty stomach, three groups will be given their respective standardized food item and blood samples will be drawn every half an hour upto 2 hours of ingestion at (minutes): 0, 30, 60, 90 and 120. Fingertip capillary blood will be used for the estimation of blood glucose using a glucometer of contour brand.
- Phase II: Exploratory Sub-Acute Phase- Two randomized cross over study
- Study population: 2 groups; patients with T2DM and non-diabetic subjects, n=50 (25 in each study population group)
- Study groups: 2 groups; mango (n=30), bread (n=20) Subjects in mango group will be further randomized into three different groups. Each group will be tested on a different variety of mango. Procedure for Phase II:
- Continuous glucose monitoring system (CGMS): It will be affixed for 3 days.
- The research team will be contacting the study subjects every day for any discomfort due to CGMS device or diet.
- On day 4 study subjects will be called to the study site and CGMS will be removed and data will be transferred to the study records.
- Study subjects will be asked to maintain a food diary and record the foods consumed during the entire period of 3 days.
- The subjects will also be asked to fill questionnaire of dietary assessment on Day 1 and Day 4 for per schedule of assessments.
- Phase III: Confirmatory Chronic Phase- Randomized controlled parallel arm study
- Study population: patients with T2DM, n=35
- Study groups: 2 groups; mango (n=20), bread (n=15) Subjects in mango group will be further randomized into two different groups. Each group will be tested on a different variety of mango.
Procedure for Phase III:
Subjects will be given glucometers and will be asked to monitor blood glucose at fasting state and after standard breakfast meal at baseline, at day 30 and day 60 in both the study groups. The intermediate term effect of mango consumption and bread consumption will be assessed at baseline and at day 60 in terms of following investigations:
- Dietary assessment
- Physical activity (PA) assessment (GPAQ)
- Blood pressure
- Anthropometry measures
- Body composition
- Biochemical investigations
- Conditions
- Normoglycemia, T2DM (Type 2 Diabetes Mellitus)
- Being tested
- Bread, Mango
- Keywords
- Insulin resistance, body composition, glycemic index
- Medical subject headings
- Diabetes Mellitus, Type 2, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BreadDietary supplement
81g (3 slices) harvest gold white bread as standard food.
MangoDietary supplement
Also called Safeda, Dushehri, Langra
250g of mango pulp of each mango variety was given to the subjects.
| Study group | Role | What they receive |
|---|---|---|
| Treatment - Mango | Other | Subjects in mango group will be further randomized into three different groups. Each group will be tested on a different variety of mango. Receives: Dietary Supplement: Mango |
| Controlled- Bread | Other | Subjects in bread group were given 81g (3 slices) harvest gold white bread as standard food in raw form. Receives: Dietary Supplement: Bread |
What is being measured
The primary outcome is the main question the study is designed to answer.
Outcome for all the phases will be as follows
Fasting glucose (mg/dL)
Measured: Baseline, after six months of intervention
Postprandial blood glucose (mg/dL)
Measured: Baseline, after six months of intervention
Glycemic indices as per Continuous glucose monitoring system (CGMS) & HbA1c (%)
Measured: Baseline, after six months of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2023
- Study start11 Feb 2022
- Primary completion15 Feb 2023
- Study completion1 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NormoglycemiaStudies 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
- Crossover
- Model description
- Patients with T2DM and non-diabetic subjects were randomized into two food groups- mango and bread for 3 days, then after a 7 days washout period, the cross-over took place.
- Masking
- None (open label)
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Diabetes Foundation, India
- Sponsor type
- University, hospital or other
- Collaborators
- Indian Council of Medical Research
- Responsible party
- Principal investigator, Dr Anoop Misra, Diabetes Foundation, India
- Investigators
- Anoop Misra, MD, Principal investigator, Fortis CDOC Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06055582
- Sponsor's protocol ID
- 5/9/1309/2020-Nut
- Status last verified
- Sep 2023
- First submitted
- 19 Jul 2023
- Last updated
- 26 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Study to Compare Effects of Mango Ingestion on Glycemia (Glycemic Response, Continuous Glucose Monitoring and Fructosamine) Insulin Resistance and Body Composition in Patients With T2DM and Non-diabetic Subjects.
- ClinicalTrials.gov ID
- NCT06055582
- Acronym / sponsor ID
- 5/9/1309/2020-Nut
- Conditions
- Normoglycemia, T2DM (Type 2 Diabetes Mellitus)
- Keywords
- Insulin resistance, body composition, glycemic index
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Diabetes Foundation, IndiaUniversity, hospital or other
- Collaborators
- Indian Council of Medical Research
- Study start
- 11 Feb 2022 (actual)
- Primary completion
- 15 Feb 2023 (actual)
- Study completion
- 1 Mar 2023 (actual)
- First posted
- 26 Sep 2023 (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.
T2DM patient will be recruited from endocrine OPD
- Clinical History and Examination:
- General Physical Examination:
- Height (cm)
- weight (kg)
- BMI (kg/m2)
- Blood Pressure (mmHg)
- Anthropometry: Circumferences and skinfold thickness will be recorded for the patients in the following manner. Circumferences:
- Waist circumference (cm)
- Hip circumference (cm)
- Mid-arm circumference (cm)
- Mid-thigh circumference (cm)
- Skin fold thickness: Skin fold thickness will be measured by using (LANGE skin fold calipers) (to nearest of 1 mm) at the following sites
- Biceps (mm)
- Triceps (mm)
- Thigh (mm)
- Calf (mm)
- Sub scapular (mm)
- Supra-iliac (mm)
- Anterior axillary fold. (mm)
- Biochemical Test: The biochemical analysis will be done using ELISA kit or commercially available kits
- Blood glucose (mg/dL)
- HbA1c (%)
- Serum insulin (μIU/mL)
- Total Cholestrol (mg/dl)
- Triglyceride (mg/dl)
- Fructosamine (umol/L)
- Adiponectin (µg/ml) -- HOMA-IR
- Body Composition Analysis (TANITA)
Detailed description
- Phase I: Exploratory Acute Phase- Stratified randomized study
- Study population: 2 groups; patients with T2DM and non-diabetic subjects n=45 (20 T2DM subject, 25 non-diabetic subjects).
- Study groups: 3 groups; OGTT (n=5), mango (n=30), bread (n=10) Subjects in mango group will be further randomized into three different groups. Each group will be tested on a different variety of mango. Procedure for Phase I: After measuring baseline glucose level on empty stomach, three groups will be given their respective standardized food item and blood samples will be drawn every half an hour upto 2 hours of ingestion at (minutes): 0, 30, 60, 90 and 120. Fingertip capillary blood will be used for the estimation of blood glucose using a glucometer of contour brand.
- Phase II: Exploratory Sub-Acute Phase- Two randomized cross over study
- Study population: 2 groups; patients with T2DM and non-diabetic subjects, n=50 (25 in each study population group)
- Study groups: 2 groups; mango (n=30), bread (n=20) Subjects in mango group will be further randomized into three different groups. Each group will be tested on a different variety of mango. Procedure for Phase II:
- Continuous glucose monitoring system (CGMS): It will be affixed for 3 days.
- The research team will be contacting the study subjects every day for any discomfort due to CGMS device or diet.
- On day 4 study subjects will be called to the study site and CGMS will be removed and data will be transferred to the study records.
- Study subjects will be asked to maintain a food diary and record the foods consumed during the entire period of 3 days.
- The subjects will also be asked to fill questionnaire of dietary assessment on Day 1 and Day 4 for per schedule of assessments.
- Phase III: Confirmatory Chronic Phase- Randomized controlled parallel arm study
- Study population: patients with T2DM, n=35
- Study groups: 2 groups; mango (n=20), bread (n=15) Subjects in mango group will be further randomized into two different groups. Each group will be tested on a different variety of mango.
Procedure for Phase III:
Subjects will be given glucometers and will be asked to monitor blood glucose at fasting state and after standard breakfast meal at baseline, at day 30 and day 60 in both the study groups. The intermediate term effect of mango consumption and bread consumption will be assessed at baseline and at day 60 in terms of following investigations:
- Dietary assessment
- Physical activity (PA) assessment (GPAQ)
- Blood pressure
- Anthropometry measures
- Body composition
- Biochemical investigations
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients with T2DM and non-diabetic subjects were randomized into two food groups- mango and bread for 3 days, then after a 7 days washout period, the cross-over took place.
| Arm | Type | Receives |
|---|---|---|
| Treatment - Mango | Other | Dietary Supplement: MangoSubjects in mango group will be further randomized into three different groups. Each group will be tested on a different variety of mango. |
| Controlled- Bread | Other | Dietary Supplement: BreadSubjects in bread group were given 81g (3 slices) harvest gold white bread as standard food in raw form. |
Who may qualify
- Ages
- 25 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- -For patients with diabetes: Stable glycemic control on metformin or sulfonylurea for past 3 months and without any major complications and HbA1C less than 8%
Key exclusion criteria (6 listed)
- Acute infections and advanced end-organ damage
- History of hepatitis or pancreatitis, abnormal liver and renal functions
- Recent (<3 months) changes in weight
- Any known allergy to mangoes and bread
- Subjects with hypothyroidism
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 |
|---|---|---|
| Bread81g (3 slices) harvest gold white bread as standard food. | Dietary supplement | Controlled- Bread |
| MangoAlso: Safeda, Dushehri, Langra250g of mango pulp of each mango variety was given to the subjects. | Dietary supplement | Treatment - Mango |
Primary outcome
Outcome for all the phases will be as follows
Time frame: Baseline, after six months of intervention
Fasting glucose (mg/dL)
Postprandial blood glucose (mg/dL)
Time frame: Baseline, after six months of intervention
Glycemic indices as per Continuous glucose monitoring system (CGMS) & HbA1c (%)
Time frame: Baseline, after six months of intervention
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 26 Sep 2023.
- 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.
Anoop Misra, MD principal investigator
Fortis CDOC Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bread and Mango in people with Normoglycemia and T2DM (Type 2 Diabetes Mellitus), 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 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: finished, as of the sponsor's last update on 26 Sep 2023. 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. 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?
Outcome for all the phases will be as follows (time frame: Baseline, after six months of intervention). The study lists 3 primary outcomes in all. 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 26 Sep 2023.