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Completed

NCT Number: NCT04923503

Diurnal Ramadan Fasting on Appetite Hormone and Metabolic Profile Among Lean, Obesity, Diabetics

Diabetes Mellitus individuals are known to have dietary rules, namely regulating the amount, type and time of eating. Ramadan fasting seems to be beneficial for people who want to reduce their weight, but it is not easy for diabetic patients. Because of its distinctive features, Ramadhan induces changes in eating habits, calorie consumption, sleeping patterns, and daily physical activity, which may contribute to changes in hunger-satiety responses and glicemic control. Examining changes in gut hormones during Ramadan fasting may reveal whether this observance could change glucose metabolism in diabetics without triggering the undesirable effect of gluconeogenesis. The proportions of fat, protein, and carbohydrate in meals vary between outside and within Ramadan. Alterations in timing and composition meal during Ramadan lead to reduced food intake may affect gut hormones and metabolic responses. The aim of this study to determine whether the effect of Ramadan fasting differed in people with DM patients, pre-DM and healthy individuals, with respect to gut hormones, body composition, metabolic parameters, and glycemic control

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Key information

Conditions

Fasting Behavior Body Weight Feeding Behavior Gut Hormone Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

35 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Etika Ratna Noer

Semarang, Central Java, 50275, Indonesia

About this study

The experimental study was performed during and after Ramadan fasting in 2021 (April to May) in Semarang, Indonesia. The present study was performed using the quasy-experimental method by pre-post measurement of three experimental groups (diabetics, Obese and healthy subjects) selected using the purposive sampling methods

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diabetics subjects: glucose fasting plasma > 200 mg/dL, with aged 35-60 years and body mass index above 25 kg/m;
  • Obese subjects: body mass index above 25 kg/m2 with aged 35-60 years and waist circumference for men >90 cm, for women > 80 cm
  • Lean subjects: body mass index below 23.5 kg/m2 with aged 35-60 years and waist circumference for men <90 cm, for women < 80 cm

Exclusion criteria

  • experienced weight loss more than 10% from the actual weight in the last three months
  • consumed medicine or supplement for weight loss diet, •. had the history of evidence of clinical depression, cognitive disorders, heart disease, cancer, liver or renal disease, chronic pulmonary disease, uncontrolled hypertension, physical disability, or other contraindications

Treatment and study plan

diurnal fasting

Behavioral

subject conduct fasting in Ramadan for 30 days

Other names: ramadan fasting

Primary outcomes

  1. change acylated ghrelin

    Time frame: 30 days

    Change from Baseline acyl ghrelin at 30 days taken in the lab from venous blood specimen

  2. change PYY

    Time frame: 30 days

    Change from Baseline PYY at 30 days taken in the lab from venous blood specimen

  3. change GLP-1

    Time frame: 30 days

    Change from Baseline GLP-1 at 30 days taken in the lab from venous blood specimen

  4. change insulin

    Time frame: 30 days

    Change from Baseline Insulin at 30 days taken in the lab from venous blood specimen

Secondary outcomes

  1. change body weight

    Time frame: 30 days

    Change from Baseline body weight at 30 days

Sponsors and collaborators

Lead sponsor

Universitas Diponegoro

Other

Registry information

Official study title

Department of Nutrition Science, Medical Faculty, Universitas Diponegoro, Semarang, Indonesia

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jun 11, 2021
Registry last updated
Jun 29, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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