Effect of Fasting and Calorie-Restricted Diets on Dopamine and Serotonin Levels Among Obese Women With BED and FA
The Effect of Intermittent Fasting Diet and Calorie-Restricted Diet on Dopamine and Serotonin Levels and Weight Management in Women With Obesity and Co-morbid Binge Eating Disorder and Food Addiction
1 other identifier
interventional
100
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 27, 2021
CompletedFirst Posted
Study publicly available on registry
May 5, 2021
CompletedStudy Start
First participant enrolled
June 20, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2022
CompletedSeptember 28, 2021
September 1, 2021
9 months
April 27, 2021
September 27, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Dopamine serum level
The level of serum dopamine in ng/ml at both baseline and 6 weeks of follow up
Through study completion, an average of 1 year
Serotonin serum level
The level of serum serotonin in ng/ml at both baseline and 6 weeks of follow up
Through study completion, an average of 1 year
food addiction disorder
by the diagnostic tool for food addiction - Yale Food Addiction Scale (YFAS), The content will be translated and the content validity will be assessed at both baseline and 6 weeks of follow-up. YFAS contains a 25-item self-report measure that includes mixed response categories (dichotomous and Likert-type format). The YFAS includes two scoring options: 1) a "symptom count" ranging from 0 to 7 that reflects the number of addiction-like criteria endorsed and 2) a dichotomous "diagnosis" that indicates whether a threshold of three or more "symptoms" plus clinically significant impairment or distress has been met. Food addiction can be "diagnosed" when three symptoms and clinically significant impairment or distress are present.
Through study completion, an average of 1 year
binge eating disorder (BED)
by the diagnostic tool, to assess BED, a previously translated and validated eating and weight patterns questionnaire (QEWP-5) will be used based on the new diagnostic and statistical manual of mental disorders-5 criteria. at both baseline and 6 weeks of follow up The screening was based on the diagnostic criteria of the DSM-5 In the original form of the QEWP-5 questionnaire, if the participant answered based on the following criteria, the participant is considered to be diagnosed with BED. * 8 and 9 if the participant answered (YES) (Binge eating) * 10, 2, 3, 4, 5, or 6 (At least one episode per a week in the last 3 months) * 11 (a through e) 3 or more items marked "YES" (At least 3 associated symptoms during binge-eating episodes) * 13 (4 0R 5) (Marked distress regarding binge eating)
Through study completion, an average of 1 year
Study Arms (5)
food addiction and binge eating follow caloric reduced -intermitted fasting diet
EXPERIMENTALObese women diagnosed with binge eating disorder and food addiction follow caloric reduced -intermitted fasting diet
food addiction and binge eating follow caloric restriction diet
ACTIVE COMPARATORObese women diagnosed with binge eating disorder and food addiction follow caloric restriction diet
binge eating disorder follow follow caloric reduced -intermitted fasting diet
EXPERIMENTALObese women diagnosed with binge eating disorder follow caloric reduced -intermitted fasting diet
binge eating disorder follow caloric restriction diet
ACTIVE COMPARATORObese women diagnosed with binge eating disorder follow a caloric restriction diet
obese women without food addiction and binge eating follow caloric restriction diet
PLACEBO COMPARATORObese women without eating disorder follow a caloric restriction diet
Interventions
obese women with food addiction and binge eating follow intermittent calorie restriction diet ( time-restricted eating - typically 16 -hour fasting and 8-hour eating)
obese women with food addiction and binge eating disorder follow a Daily calorie restriction diet
obese women without food addiction and binge eating disorder follow a Daily calorie restriction diet
Eligibility Criteria
You may qualify if:
- Females,
- Aged between 20-40 yr,
- Premenopausal,
- BMI(\>30 kg/m)
You may not qualify if:
- Male
- Females aged \<20-40\< yr,
- Menopausal,
- BMI(\<30 kg/m)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Zainb zaiter clinic
Amman, Jordan
Related Publications (11)
Adams RC, Sedgmond J, Maizey L, Chambers CD, Lawrence NS. Food Addiction: Implications for the Diagnosis and Treatment of Overeating. Nutrients. 2019 Sep 4;11(9):2086. doi: 10.3390/nu11092086.
PMID: 31487791BACKGROUNDAjlouni K, Jaddou H, Batieha A. Obesity in Jordan. Int J Obes Relat Metab Disord. 1998 Jul;22(7):624-8. doi: 10.1038/sj.ijo.0800637.
PMID: 9705020BACKGROUNDAllen GF, Ullah Y, Hargreaves IP, Land JM, Heales SJ. Dopamine but not l-dopa stimulates neural glutathione metabolism. Potential implications for Parkinson's and other dopamine deficiency states. Neurochem Int. 2013 Apr;62(5):684-94. doi: 10.1016/j.neuint.2012.12.004. Epub 2012 Dec 19.
PMID: 23261515BACKGROUNDAvena NM, Bocarsly ME, Hoebel BG, Gold MS. Overlaps in the nosology of substance abuse and overeating: the translational implications of "food addiction". Curr Drug Abuse Rev. 2011 Sep;4(3):133-9. doi: 10.2174/1874473711104030133.
PMID: 21999687BACKGROUNDBastani A, Rajabi S, Kianimarkani F. The Effects of Fasting During Ramadan on the Concentration of Serotonin, Dopamine, Brain-Derived Neurotrophic Factor and Nerve Growth Factor. Neurol Int. 2017 Jun 23;9(2):7043. doi: 10.4081/ni.2017.7043. eCollection 2017 Jun 23.
PMID: 28713531BACKGROUNDBello NT, Hajnal A. Dopamine and binge eating behaviors. Pharmacol Biochem Behav. 2010 Nov;97(1):25-33. doi: 10.1016/j.pbb.2010.04.016. Epub 2010 Apr 24.
PMID: 20417658BACKGROUNDBrownley KA, Berkman ND, Sedway JA, Lohr KN, Bulik CM. Binge eating disorder treatment: a systematic review of randomized controlled trials. Int J Eat Disord. 2007 May;40(4):337-48. doi: 10.1002/eat.20370.
PMID: 17370289BACKGROUNDCamandola S, Mattson MP. Brain metabolism in health, aging, and neurodegeneration. EMBO J. 2017 Jun 1;36(11):1474-1492. doi: 10.15252/embj.201695810. Epub 2017 Apr 24.
PMID: 28438892BACKGROUNDCitrome L. A primer on binge eating disorder diagnosis and management. CNS Spectr. 2015 Dec;20 Suppl 1:44-50; quiz 51. doi: 10.1017/S1092852915000772.
PMID: 26683528BACKGROUNDda Luz FQ, Hay P, Gibson AA, Touyz SW, Swinbourne JM, Roekenes JA, Sainsbury A. Does severe dietary energy restriction increase binge eating in overweight or obese individuals? A systematic review. Obes Rev. 2015 Aug;16(8):652-65. doi: 10.1111/obr.12295. Epub 2015 Jun 11.
PMID: 26094791BACKGROUNDDavis C. A commentary on the associations among 'food addiction', binge eating disorder, and obesity: Overlapping conditions with idiosyncratic clinical features. Appetite. 2017 Aug 1;115:3-8. doi: 10.1016/j.appet.2016.11.001. Epub 2016 Nov 2.
PMID: 27816464BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Rima H Mashal, Assoc. Prof
The University of Jordan
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
April 27, 2021
First Posted
May 5, 2021
Study Start
June 20, 2021
Primary Completion
March 30, 2022
Study Completion
June 30, 2022
Last Updated
September 28, 2021
Record last verified: 2021-09
Data Sharing
- IPD Sharing
- Will not share
The center (Jordan University hospital) where the study conducted emphasis of maintaining privacy and confidentiality of the participants' data