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

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

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)

Study Overview

• Status: Completed
• Conditions: T2DM (Type 2 Diabetes Mellitus); Normoglycemia
• Intervention / Treatment: Dietary supplement: Mango; Dietary supplement: Bread

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 Type: Interventional
• Enrollment (Actual): 130
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Delhi
    • New Delhi, Delhi, India, 110048
      • Fortis CDOC Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; 250g of mango pulp of each mango variety was given to the subjects.; Other Names: Safeda, Dushehri, Langra
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; 81g (3 slices) harvest gold white bread as standard food.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Outcome for all the phases will be as follows	Fasting glucose (mg/dL)	Baseline, after six months of intervention
Postprandial blood glucose (mg/dL)		Baseline, after six months of intervention
Glycemic indices as per Continuous glucose monitoring system (CGMS) & HbA1c (%)		Baseline, after six months of intervention

Collaborators and Investigators

• Sponsor: Diabetes Foundation, India
• Collaborators: Indian Council of Medical Research
• Investigators: Principal Investigator: Anoop Misra, MD, Fortis CDOC Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 11, 2022
• Primary Completion (Actual): February 15, 2023
• Study Completion (Actual): March 1, 2023

Study Registration Dates

• First Submitted: July 19, 2023
• First Submitted That Met QC Criteria: September 20, 2023
• First Posted (Actual): September 26, 2023

Study Record Updates

• Last Update Posted (Actual): September 26, 2023
• Last Update Submitted That Met QC Criteria: September 20, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Insulin resistance; glycemic index; body composition
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: 5/9/1309/2020-Nut

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No