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

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

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

Study Overview

• Status: Completed
• Conditions: Fasting; Gut Hormone
• Intervention / Treatment: Behavioral: diurnal fasting

Detailed 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

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Indonesia
  • Central Java
    • Semarang, Central Java, Indonesia, 50275
      • Etika Ratna Noer

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: lean ramadan fasting; conduct ramadan fasting for 30 days	Behavioral: diurnal fasting; subject conduct fasting in Ramadan for 30 days; Other Names: ramadan fasting
Experimental: obese ramadan fasting; conduct ramadan fasting for 30 days	Behavioral: diurnal fasting; subject conduct fasting in Ramadan for 30 days; Other Names: ramadan fasting
Experimental: diabetics ramadan fasting; conduct ramadan fasting for 30 days	Behavioral: diurnal fasting; subject conduct fasting in Ramadan for 30 days; Other Names: ramadan fasting

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change acylated ghrelin	Change from Baseline acyl ghrelin at 30 days taken in the lab from venous blood specimen	30 days
change PYY	Change from Baseline PYY at 30 days taken in the lab from venous blood specimen	30 days
change GLP-1	Change from Baseline GLP-1 at 30 days taken in the lab from venous blood specimen	30 days
change insulin	Change from Baseline Insulin at 30 days taken in the lab from venous blood specimen	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change body weight	Change from Baseline body weight at 30 days	30 days

Collaborators and Investigators

• Sponsor: Universitas Diponegoro
• Investigators: Principal Investigator: Etika R Noer, Diponegoro University

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2021
• Primary Completion (Actual): April 12, 2021
• Study Completion (Actual): May 1, 2021

Study Registration Dates

• First Submitted: June 6, 2021
• First Submitted That Met QC Criteria: June 6, 2021
• First Posted (Actual): June 11, 2021

Study Record Updates

• Last Update Posted (Actual): June 29, 2021
• Last Update Submitted That Met QC Criteria: June 26, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: obesity; lean; metabolic parameters; gut hormones; diabetics; ramadan fasting
• Other Study ID Numbers: RMD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: the result of this study is available to cite everyone
• IPD Sharing Time Frame: anytime
• IPD Sharing Access Criteria: etikaratna@fk.undip.ac.id
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No