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

NCT ID: NCT06055582

Last Updated: 2023-09-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 130 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-11
• Study Completion Date: 2023-03-01

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)

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

Conditions

Normoglycemia; T2DM (Type 2 Diabetes Mellitus)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: OTHER

Mango

Intervention Type: DIETARY_SUPPLEMENT

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

Controlled- Bread

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

Group Type: OTHER

Bread

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

Bread

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

Intervention Type: DIETARY_SUPPLEMENT

Mango

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

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Safeda, Dushehri, Langra

Eligibility 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.

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Indian Council of Medical Research

OTHER_GOV

Sponsor Role: collaborator

Diabetes Foundation, India

OTHER

Sponsor Role: lead

Responsible Party

Dr Anoop Misra

Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Anoop Misra, MD

Role: PRINCIPAL_INVESTIGATOR

Fortis CDOC Hospital

Locations

Fortis CDOC Hospital

New Delhi, National Capital Territory of Delhi, India

Countries

India

Other Identifiers

5/9/1309/2020-Nut

Identifier Type: -

Identifier Source: org_study_id