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

NCT06055582 | Completed DMC

• 1 other identifier: 5/9/1309/2020-Nut
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

Brief Summary

T2DM patient will be recruited from endocrine OPD

• 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.
• 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)

Conditions

Normoglycemia; T2DM (Type 2 Diabetes Mellitus)

Keywords

Insulin resistance; body composition; glycemic index

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

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.

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.

Dietary Supplement: Bread

Interventions

Bread DIETARY_SUPPLEMENT

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

Controlled- Bread

Mango DIETARY_SUPPLEMENT

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

Also known as: Safeda, Dushehri, Langra

Treatment - Mango

Eligibility Criteria

• Age: 25 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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%

You may not qualify if:

• 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.

Sponsors & Collaborators

• Diabetes Foundation, India: lead
• Indian Council of Medical Research: collaborator

Study Sites (1)

Fortis CDOC Hospital

New Delhi, National Capital Territory of Delhi, 110048, India

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Insulin Resistance

Interventions

Bread; Mangifera indica extract

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperinsulinism

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Anoop Misra, MD

  Fortis CDOC Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Patients were recruited from Fortis C-DOC OPD.
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Model Details: 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.

Study Record Dates

• First Submitted: July 19, 2023
• First Posted: September 26, 2023
• Study Start: February 11, 2022
• Primary Completion: February 15, 2023
• Study Completion: March 1, 2023
• Last Updated: September 26, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)