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

NCT ID: NCT04923503

Last Updated: 2021-06-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-01

Study Completion Date

2021-05-01

Brief Summary

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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

Detailed Description

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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

Conditions

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Fasting Gut Hormone

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

three arm parallel group with 45 subjects:

1. fasting in lean group
2. fasting in obese group
3. fasting in diabetics group
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors
subject with random allocation Investigator do not know the group the analysator do not know the group

Study Groups

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lean ramadan fasting

conduct ramadan fasting for 30 days

Group Type EXPERIMENTAL

diurnal fasting

Intervention Type BEHAVIORAL

subject conduct fasting in Ramadan for 30 days

obese ramadan fasting

conduct ramadan fasting for 30 days

Group Type EXPERIMENTAL

diurnal fasting

Intervention Type BEHAVIORAL

subject conduct fasting in Ramadan for 30 days

diabetics ramadan fasting

conduct ramadan fasting for 30 days

Group Type EXPERIMENTAL

diurnal fasting

Intervention Type BEHAVIORAL

subject conduct fasting in Ramadan for 30 days

Interventions

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diurnal fasting

subject conduct fasting in Ramadan for 30 days

Intervention Type BEHAVIORAL

Other Intervention Names

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ramadan fasting

Eligibility Criteria

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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
Minimum Eligible Age

35 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universitas Diponegoro

OTHER

Sponsor Role lead

Responsible Party

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Etika Ratna Noer

Department of Nutrition, Medical Faculty

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Etika R Noer

Role: PRINCIPAL_INVESTIGATOR

Diponegoro University

Locations

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Etika Ratna Noer

Semarang, Central Java, Indonesia

Site Status

Countries

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Indonesia

Other Identifiers

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RMD

Identifier Type: -

Identifier Source: org_study_id

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