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

Fasting Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04923503
• Other study ID #: RMD
• Status: Completed
• Phase: N/A
• Start date: March 1, 2021
• Est. completion date: May 1, 2021

Study information

• Verified date: June 2021
• Source: Universitas Diponegoro
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: May 1, 2021
• Est. primary completion date: April 12, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Fasting

Intervention

Behavioral:
• diurnal fasting
subject conduct fasting in Ramadan for 30 days

Locations

Country	Name	City	State
Indonesia	Etika Ratna Noer	Semarang	Central Java

Sponsors (1)

Lead Sponsor	Collaborator
Universitas Diponegoro

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change acylated ghrelin	Change from Baseline acyl ghrelin at 30 days taken in the lab from venous blood specimen	30 days
Primary	change PYY	Change from Baseline PYY at 30 days taken in the lab from venous blood specimen	30 days
Primary	change GLP-1	Change from Baseline GLP-1 at 30 days taken in the lab from venous blood specimen	30 days
Primary	change insulin	Change from Baseline Insulin at 30 days taken in the lab from venous blood specimen	30 days
Secondary	change body weight	Change from Baseline body weight at 30 days	30 days