Comparative effects of consuming various whole fruits before meals on fasting blood glucose and insulin levels among patients with type 2 diabetes mellitus in Indonesia

Low-, medium and high glycaemic index fruits meal sequence randomized controlled trial among type 2 diabetes mellitus (T2DM) in Indonesia

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN10024302

Enrollment

Registered

2022-01-20

Start date

2018-11-01

Completion date

Unknown

Last updated

2022-02-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 diabetes mellitus Nutritional, Metabolic, Endocrine Type 2 diabetes mellitus

Interventions

The researchers randomly chose four from 12 Health Clinics for Management Program of Chronic Diseases in Surakarta city, Central Java province which had sufficient patients with type 2 diabetes. To re

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Aged 30–75 years old 2. Routinely treated by anti-diabetic drugs except for DPP4 inhibitor 3. Able to ingest fresh fruits

Exclusion criteria

Exclusion criteria: 1. Pregnant 2. Smoking 3. Chronic disease (e.g. heart, kidney, liver disease) 4. Insulin and DPP4 inhibitor therapy 5. Not routinely visiting the clinics

Design outcomes

Primary

Measure	Time frame
1. Fasting blood glucose (FBG) levels measured using the enzymatic method (glucose oxidase – peroxidase aminoantypirin) at 1, 7, 14 and 21 days 2. Insulin levels measured using an enzyme-linked immunosorbent assay (ELISA) kit at 1, 7, 14 and 21 days 3. HOMA-ß ratio calculated using the FBG and insulin levels with the formula: (HOMA-ß = 20 X insulin level) / (FBG level – 3.5) at 1, 7, 14 and 21 days. 4. Acetic acid levels determined using gas chromatography-mass spectrometry at 14 and 21 days	—

Measure

Time frame

1. Fasting blood glucose (FBG) levels measured using the enzymatic method (glucose oxidase – peroxidase aminoantypirin) at 1, 7, 14 and 21 days 2. Insulin levels measured using an enzyme-linked immunosorbent assay (ELISA) kit at 1, 7, 14 and 21 days 3. HOMA-ß ratio calculated using the FBG and insulin levels with the formula: (HOMA-ß = 20 X insulin level) / (FBG level – 3.5) at 1, 7, 14 and 21 days. 4. Acetic acid levels determined using gas chromatography-mass spectrometry at 14 and 21 days

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Secondary

Measure	Time frame
1. Basic characteristics including age, gender, marital status, education, job, food allergy, duration of type 2 diabetes illness, and type of oral antidiabetic drugs, collected using open questionnaires consisting of short questions 1 week before the research commenced. 2. Physical activity collected using a global physical activity questionnaire from the World Health Organization (2016), which asked how long the patients performed vigorous or moderate physical activity during active and recreational times, what kind of transportation the patients went to their work or a specific place, and how long the patients performed mild physical activities/day such as sitting, lying and watching television, 1 week before the research commenced. 2. Daily food intake collected using a 24-hour food recall questionnaire at 1, 7, 14 and 21 days and converted into daily intake values of macro- and micronutrients using the free nutrisurvey software (https://www.nutrisurvey.de), which has been translated into Indonesian 3. Anthropometric data such as body weight, height and waist circumference measured using a scale and a tape measure at 1, 7, 14 and 21 days 4. Nutrition status presented as body mass index with the formula: body weight (kg)/ height² (m²), based on the Indonesian Ministry of Health (2013), at 1, 7, 14 and 21 days 5. Waist circumference/height ratio in cm determined at 1, 7, 14 and 21 days 6. DPP4 enzyme activity determined using a colorimetric assay with a synthetic Gly-Pro-p nitroanilide substrate at 1, 7, 14 and 21 days 7. HOMA-IR ratio calculated using the FBG and insulin levels with the formula: (HOMA-IR = FBG X insulin levels) / 22.5 at 1, 7, 14 and 21 days	—

Measure

Time frame

1. Basic characteristics including age, gender, marital status, education, job, food allergy, duration of type 2 diabetes illness, and type of oral antidiabetic drugs, collected using open questionnaires consisting of short questions 1 week before the research commenced. 2. Physical activity collected using a global physical activity questionnaire from the World Health Organization (2016), which asked how long the patients performed vigorous or moderate physical activity during active and recreational times, what kind of transportation the patients went to their work or a specific place, and how long the patients performed mild physical activities/day such as sitting, lying and watching television, 1 week before the research commenced. 2. Daily food intake collected using a 24-hour food recall questionnaire at 1, 7, 14 and 21 days and converted into daily intake values of macro- and micronutrients using the free nutrisurvey software (https://www.nutrisurvey.de), which has been translated into Indonesian 3. Anthropometric data such as body weight, height and waist circumference measured using a scale and a tape measure at 1, 7, 14 and 21 days 4. Nutrition status presented as body mass index with the formula: body weight (kg)/ height² (m²), based on the Indonesian Ministry of Health (2013), at 1, 7, 14 and 21 days 5. Waist circumference/height ratio in cm determined at 1, 7, 14 and 21 days 6. DPP4 enzyme activity determined using a colorimetric assay with a synthetic Gly-Pro-p nitroanilide substrate at 1, 7, 14 and 21 days 7. HOMA-IR ratio calculated using the FBG and insulin levels with the formula: (HOMA-IR = FBG X insulin levels) / 22.5 at 1, 7, 14 and 21 days

—

Countries

Indonesia

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026