MedTrace Logo

Effect of Fasting and Calorie-Restricted Diets on Dopamine and Serotonin Levels Among Obese Women With BED and FA

NCT04873648 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2021-09-28

No results posted yet for this study

Summary

Obesity presents a substantial economic burden in Jordan. Binge eating disorder (BED) and food addiction (FA) are the most common eating disorders associated with obesity. BED and FA most therapeutic approach is cognitive-behavioral therapy. Dopamine (DA) and serotonin (5HT) the major neurotransmitter responsible for FA and BED. Daily calorie restriction (CR) and intermittent calorie restriction (ICR) are two forms of diet therapy that can help weight loss. Prolong fasting increases lipolysis and elevates ketones bodies' levels in the brain led to a significant increase in the DA and 5HT. No prior human research has examined the effect of ICR (model 8:16) on DA and 5HT levels and weight reduction on obese with BED and FA. Therefore, A Randomized, controlled trial of 6 weeks follow-up will be used. A sample of 100 obese women will be selected to be randomly assigned to daily CR or ICR, or control group without FA or BED for a period of 6 weeks. Participants will be undergoing nutrition assessment, Anthropometrics assessment, food Addiction assessment (YFAS), binge eating assessment (BEDS-7), and hormonal level (DA\&5HT) at baseline and after 6 weeks. The investigators anticipated that CR and ICR (model8:16) will significantly induce DA\&5HT level changes and that ICR (model8:16) will be significantly more effective than CR in reducing BED \& FA.

Conditions

Interventions

BEHAVIORAL

caloric reduced -intermitted fasting diet

obese women with food addiction and binge eating follow intermittent calorie restriction diet ( time-restricted eating - typically 16 -hour fasting and 8-hour eating)

BEHAVIORAL

Daily calorie restriction

obese women with food addiction and binge eating disorder follow a Daily calorie restriction diet

BEHAVIORAL

Control group

obese women without food addiction and binge eating disorder follow a Daily calorie restriction diet

Sponsors & Collaborators

  • University of Jordan

    lead OTHER

Principal Investigators

  • Rima H Mashal, Assoc. Prof · The University of Jordan

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-20
Primary Completion
2022-03-30
Completion
2022-06-30

Countries

  • Jordan

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04873648 on ClinicalTrials.gov