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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06055582
Recruitment Status : Completed
First Posted : September 26, 2023
Last Update Posted : September 26, 2023
Sponsor:
Collaborator:
Indian Council of Medical Research
Information provided by (Responsible Party):
Dr Anoop Misra, Diabetes Foundation, India

Study Description
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Brief 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)

Condition or disease Intervention/treatment Phase
Normoglycemia T2DM (Type 2 Diabetes Mellitus) Dietary Supplement: Bread Dietary Supplement: Mango Not Applicable

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
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention 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)
Masking Description: Patients were recruited from Fortis C-DOC OPD.
Primary Purpose: Prevention
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.
Actual Study Start Date : February 11, 2022
Actual Primary Completion Date : February 15, 2023
Actual Study Completion Date : March 1, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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
250g of mango pulp of each mango variety was given to the subjects.
Other Name: Safeda, Dushehri, Langra
Controlled- Bread
Subjects in bread group were given 81g (3 slices) harvest gold white bread as standard food in raw form.
 Dietary Supplement: Bread
81g (3 slices) harvest gold white bread as standard food.


Outcome Measures
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Primary Outcome Measures :
  1. Outcome for all the phases will be as follows [ Time Frame: Baseline, after six months of intervention ]
    Fasting glucose (mg/dL)

  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 ]

Eligibility Criteria
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Ages Eligible for Study:   25 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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:

  • 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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06055582


Locations
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India
Fortis CDOC Hospital
New Delhi, Delhi, India, 110048
Sponsors and Collaborators
Diabetes Foundation, India
Indian Council of Medical Research
Investigators
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Principal Investigator: Anoop Misra, MD Fortis CDOC Hospital
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Dr Anoop Misra, Director, Diabetes Foundation, India
ClinicalTrials.gov Identifier: NCT06055582    
Other Study ID Numbers: 5/9/1309/2020-Nut
First Posted: September 26, 2023    Key Record Dates
Last Update Posted: September 26, 2023
Last Verified: September 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr Anoop Misra, Diabetes Foundation, India:
Insulin resistance
body composition
glycemic index
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases