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CompletedNCT06055582Updated Sep 26, 2023

To Study the Effects of Mango Ingestion in T2DM and Non-diabetic Subjects.

An interventional study of Bread and Mango in Normoglycemia and T2DM (Type 2 Diabetes Mellitus), sponsored by Diabetes Foundation, India. Completed at 1 site in India. Open to participants aged 25 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-09-26.

Sponsored by Diabetes Foundation, India · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 1 year 5 months after the study started (first participant enrolled Feb 2022, registered Jul 2023).
Phase
Not applicable
Study type
Interventional
Enrollment
130
Allocation
Randomized
Ages
25 Years to 60 Years
Sex
All
01

Study 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.

      Circumferences:

      • Waist circumference (cm)
      • Hip circumference (cm)
      • Mid-arm circumference (cm)
      • Mid-thigh circumference (cm)

    3. 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)

  2. 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
  3. Body Composition Analysis (TANITA)
Read the detailed description

  1. 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.

  2. 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:

    1. Continuous glucose monitoring system (CGMS): It will be affixed for 3 days.
    2. The research team will be contacting the study subjects every day for any discomfort due to CGMS device or diet.
    3. 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.
    4. Study subjects will be asked to maintain a food diary and record the foods consumed during the entire period of 3 days.
    5. The subjects will also be asked to fill questionnaire of dietary assessment on Day 1 and Day 4 for per schedule of assessments.

  3. 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:

  1. Dietary assessment
  2. Physical activity (PA) assessment (GPAQ)
  3. Blood pressure
  4. Anthropometry measures
  5. Body composition
  6. Biochemical investigations
02

Conditions studied

  • Normoglycemia
  • T2DM (Type 2 Diabetes Mellitus)

Keywords

  • Insulin resistance
  • body composition
  • glycemic index
03

In context

Diabetes Mellitus, Type 2

9,359 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,318 are open to participants now.

This study's enrollment of 130 is above the median of 80 across 7,525 interventional studies indexed under Diabetes Mellitus, Type 2.

Browse Diabetes Mellitus, Type 2 studies →

Lead sponsor

Diabetes Foundation, India is the lead sponsor of 29 studies on the registry; 13 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
25 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

-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%

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
130 participants (actual)

Study arms

  • Other
    Treatment - Mango

    Subjects in mango group will be further randomized into three different groups. Each group will be tested on a different variety of mango.

    Dietary Supplement: Mango

  • Other
    Controlled- Bread

    Subjects in bread group were given 81g (3 slices) harvest gold white bread as standard food in raw form.

    Dietary Supplement: Bread

Interventions

  • Dietary supplementBread

    81g (3 slices) harvest gold white bread as standard food.

  • Dietary supplementMango

    250g of mango pulp of each mango variety was given to the subjects.

    Also known as: Safeda, Dushehri, Langra

06

What researchers measure

Primary outcomes

  1. Outcome for all the phases will be as follows

    Fasting glucose (mg/dL)

    Time frame: Baseline, after six months of intervention

  2. Postprandial blood glucose (mg/dL)

    Time frame: Baseline, after six months of intervention

  3. Glycemic indices as per Continuous glucose monitoring system (CGMS) & HbA1c (%)

    Time frame: Baseline, after six months of intervention

07

Study locations

1 site
  • Fortis CDOC Hospital
    New Delhi, Delhi 110048, India
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 26, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06055582
Lead sponsor
Diabetes Foundation, India
Collaborators
Indian Council of Medical Research
Responsible party
Dr Anoop Misra (Director, Diabetes Foundation, India) — Principal investigator
First posted
Sep 26, 2023
Start date
Feb 11, 2022
Primary completion
Feb 15, 2023
Completion
Mar 1, 2023
Last update
Sep 26, 2023

Study contacts

Anoop Misra, MD
principal investigator · Fortis CDOC Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.

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