Obesity Clinical Trial
Official title:
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
NCT number | NCT04873648 |
Other study ID # | 9/8/2020 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | June 20, 2021 |
Est. completion date | June 30, 2022 |
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.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | June 30, 2022 |
Est. primary completion date | March 30, 2022 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 20 Years to 40 Years |
Eligibility | Inclusion Criteria: - Females, - Aged between 20-40 yr, - Premenopausal, - BMI(>30 kg/m) Exclusion Criteria: - Male - Females aged <20-40< yr, - Menopausal, - BMI(<30 kg/m) |
Country | Name | City | State |
---|---|---|---|
Jordan | Zainb zaiter clinic | Amman |
Lead Sponsor | Collaborator |
---|---|
University of Jordan |
Jordan,
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). pii: E2086. doi: 10.3390/nu11092086. Review. — View Citation
Ajlouni K, Jaddou H, Batieha A. Obesity in Jordan. Int J Obes Relat Metab Disord. 1998 Jul;22(7):624-8. — View Citation
Allen 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. — View Citation
Avena 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. Review. — View Citation
Bastani 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. — View Citation
Bello 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. Review. — View Citation
Brownley 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. Review. — View Citation
Camandola 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. Review. — View Citation
Citrome 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. Review. — View Citation
da 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. — View Citation
Davis 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. — View Citation
* Note: There are 11 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 |
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