Eating DisordersNCT04873648
Effect of Fasting and Calorie-Restricted Diets on Dopamine and Serotonin Levels Among Obese Women With BED and FA
A study testing caloric reduced -intermitted fasting diet and Daily calorie restriction in people with Eating Disorders and Intermittent Fasting, run by University of Jordan at 1 site in Jordan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Eating Disorders, Intermittent Fasting, Obesity
- What is being tested?
- caloric reduced -intermitted fasting diet and Daily calorie restriction
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteJordan
- Study dates
- 20 Jun 2021to 30 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Females,
- Aged between 20-40 yr,
- Premenopausal,
- BMI(>30 kg/m)
Who cannot join
- Male
- Females aged <20-40< yr,
- Menopausal,
- BMI(<30 kg/m)
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the detailed description
This study will be conduct at nutritional and counseling center. This center is located at the south area of the city: Irbid- Jordan. It is licensed by the ministry of the health as a private nutritional center. This study has approval by Research Ethics Committee at the University of Jordan and by the Institutional Review Board (IRB) of Jordan University.
The present study is composed of 2 phases. In phase one random sample of two hundred (500) obese women aged 20-40 years will be selected initially to estimate the occurrence of binge eating disorder and food addiction. Phase two will be conducted on a nested sample of 100 obese women who selected to compare the effectiveness of dietary restriction versus intermittent fasting diet on weight reduction, hormonal changes among binge eaters and food addict women. These two groups will be compared with a control group (20 obese women without FA or BED).
The exclusion criteria will be as follows: subjects who get pregnant during the period of study, subjects with certain diseases such as chronic renal failure, chronic liver diseases, renal calculus, depression, subjects who were taking antidepressant drugs and any woman follows special diet Participants' information will be treated confidentially. However, only the researcher (PhD student) will know participants' names and she is the only one who will give them identification (ID) number The personal questionnaire will contain questions related to age, gender, education, employment, family income/month, residency area, smoking status, family history of FA, BED, depression, medications, previous and current health problems. As well as, questions about certain eating habits will be asked
Phase One:
A convenient sample of two 500 obese women aged 20-40 years who meets the inclusion criteria and agree to participate in the present study will be recruited in the present study. All selected sample will be assessed for BED and FA using the food Addiction assessment tool (YFAS), binge eating assessment (QEWP-5) .Also physical activity level will be assessed by GPPAQ (General Practice Physical Activity Questionnaire). Each subject will signed a consent form will be given an information sheet explaining the general background of the study regarding the research objectives Phase Two
The Intervention Procedure:
A Randomized, controlled trial of 6 weeks follow up will be conducted at the nutritional counseling center, Irbid, Jordan. A nested sample of 100 obese women will be selected to compare the effectiveness of dietary restriction versus intermittent fasting diet on weight reduction and hormonal changes among binge eaters and food addict women. After the completion of baseline measurement of anthropometric and biochemical data, subjects will be randomly assigned to daily calorie restriction (CR) or intermittent calorie restriction (ICR),or control group without FA or BED for a period of 6 weeks. All Subjects will follow the standard regimen that includes restricted calories diet, detailed individualized balanced menu (either regular diet or time restricted diet) based on the subject's baseline body weight and height. Macronutrient distribution of the assigned diets will provide carbohydrate (55-60%), protein (15-20%), fat (<30%). Instructions and counseling will be provided to all subjects individually; and they will be monitored every two weeks by the researcher. Each participant will be evaluated and monitored separately, and all information obtained will be confidential. Daily calorie requirements will be calculated using the Harris benedict equation for each subject, taking into consideration the activity level. About 1100 kcal/day deficit from initial energy body needs will be applied for each woman, and the expected calories content of the weight-reducing diets, which will be between 1200-1500 kcal/ day.
Women: (REE= 447.593 + 3.098 x (Ht cm) + 9.247 x (Wt kg) - 4.330 x (Age)) To monitor and evaluated the adherence of participants to their diet, they will be provide daily food record sheet, these sheet will be reviewed and discussed with the researcher.
Overnight fasting blood samples will be withdrawn from all groups before and after 6 weeks of the dietary intervention trial. Each time, a licensed Phlebotomist will collect about 20 mL of blood from each woman in tubes containing EDTA as anticoagulant. Samples then will be centrifuged immediately for 20 minutes at 2500 g at 4°C and plasma will be collected in 1.5 mL micro tubes and stored at -80°C until they were analyzed. Blood sample preparation and centrifugation will be performed by a specialist at the nutritional counseling center, Irbid, Jordan. The blood samples then will be transported and stored at -20°C until analyses in a private laboratory. Plasma samples will be assayed for dopamine and serotonin levels using sensitive ELISA kits for the quantification of Dopamine and serotonin.
- Conditions
- Eating Disorders, Intermittent Fasting, Obesity
- Being tested
- caloric reduced -intermitted fasting diet, Daily calorie restriction, Control group
- Keywords
- Eating Disorders, Intermitted Fasting, Obesity, Dopamine, Serotonin
- Medical subject headings
- Feeding and Eating Disorders, Intermittent Fasting, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
caloric reduced -intermitted fasting dietBehavioural
Also called Treatment
obese women with food addiction and binge eating follow intermittent calorie restriction diet ( time-restricted eating - typically 16 -hour fasting and 8-hour eating)
Daily calorie restrictionBehavioural
Also called Active comparative treatment
obese women with food addiction and binge eating disorder follow a Daily calorie restriction diet
Control groupBehavioural
obese women without food addiction and binge eating disorder follow a Daily calorie restriction diet
| Study group | Role | What they receive |
|---|---|---|
| food addiction and binge eating follow caloric reduced -intermitted fasting diet | Experimental | Obese women diagnosed with binge eating disorder and food addiction follow caloric reduced -intermitted fasting diet Receives: Behavioral: caloric reduced -intermitted fasting diet |
| food addiction and binge eating follow caloric restriction diet | Active comparator | Obese women diagnosed with binge eating disorder and food addiction follow caloric restriction diet Receives: Behavioral: Daily calorie restriction |
| binge eating disorder follow follow caloric reduced -intermitted fasting diet | Experimental | Obese women diagnosed with binge eating disorder follow caloric reduced -intermitted fasting diet Receives: Behavioral: caloric reduced -intermitted fasting diet |
| binge eating disorder follow caloric restriction diet | Active comparator | Obese women diagnosed with binge eating disorder follow a caloric restriction diet Receives: Behavioral: Daily calorie restriction |
| obese women without food addiction and binge eating follow caloric restriction diet | Placebo comparator | Obese women without eating disorder follow a caloric restriction diet Receives: Behavioral: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dopamine serum level
The level of serum dopamine in ng/ml at both baseline and 6 weeks of follow up
Measured: 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
Measured: 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.
Measured: 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)
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2021
- Study start20 Jun 2021
- Primary completion30 Mar 2022 (estimated)
- Study completion30 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Eating DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Jordan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, zainab zueter, University of Jordan
- Investigators
- Rima H Mashal, Assoc. Prof, Study chair, University of Jordan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04873648
- Sponsor's protocol ID
- 9/8/2020
- Status last verified
- Sep 2021
- First submitted
- 27 Apr 2021
- Last updated
- 28 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The center (Jordan University hospital) where the study conducted emphasis of maintaining privacy and confidentiality of the participants' data
Publications
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.
PubMed 31487791Ajlouni 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.
PubMed 9705020Allen 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.
PubMed 23261515Avena 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.
PubMed 21999687Bastani 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.
PubMed 28713531Bello 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.
PubMed 20417658Brownley 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.
PubMed 17370289Camandola 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.
PubMed 28438892Citrome 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.
PubMed 26683528da 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.
PubMed 26094791Davis 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.
PubMed 27816464
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04873648
- Acronym / sponsor ID
- 9/8/2020
- Conditions
- Eating Disorders, Intermittent Fasting, Obesity
- Keywords
- Eating Disorders, Intermitted Fasting, Obesity, Dopamine, Serotonin
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of JordanUniversity, hospital or other
- Study start
- 20 Jun 2021 (actual)
- Primary completion
- 30 Mar 2022 (estimated)
- Study completion
- 30 Jun 2022 (estimated)
- First posted
- 5 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study will be conduct at nutritional and counseling center. This center is located at the south area of the city: Irbid- Jordan. It is licensed by the ministry of the health as a private nutritional center. This study has approval by Research Ethics Committee at the University of Jordan and by the Institutional Review Board (IRB) of Jordan University.
The present study is composed of 2 phases. In phase one random sample of two hundred (500) obese women aged 20-40 years will be selected initially to estimate the occurrence of binge eating disorder and food addiction. Phase two will be conducted on a nested sample of 100 obese women who selected to compare the effectiveness of dietary restriction versus intermittent fasting diet on weight reduction, hormonal changes among binge eaters and food addict women. These two groups will be compared with a control group (20 obese women without FA or BED).
The exclusion criteria will be as follows: subjects who get pregnant during the period of study, subjects with certain diseases such as chronic renal failure, chronic liver diseases, renal calculus, depression, subjects who were taking antidepressant drugs and any woman follows special diet Participants' information will be treated confidentially. However, only the researcher (PhD student) will know participants' names and she is the only one who will give them identification (ID) number The personal questionnaire will contain questions related to age, gender, education, employment, family income/month, residency area, smoking status, family history of FA, BED, depression, medications, previous and current health problems. As well as, questions about certain eating habits will be asked
Phase One:
A convenient sample of two 500 obese women aged 20-40 years who meets the inclusion criteria and agree to participate in the present study will be recruited in the present study. All selected sample will be assessed for BED and FA using the food Addiction assessment tool (YFAS), binge eating assessment (QEWP-5) .Also physical activity level will be assessed by GPPAQ (General Practice Physical Activity Questionnaire). Each subject will signed a consent form will be given an information sheet explaining the general background of the study regarding the research objectives Phase Two
The Intervention Procedure:
A Randomized, controlled trial of 6 weeks follow up will be conducted at the nutritional counseling center, Irbid, Jordan. A nested sample of 100 obese women will be selected to compare the effectiveness of dietary restriction versus intermittent fasting diet on weight reduction and hormonal changes among binge eaters and food addict women. After the completion of baseline measurement of anthropometric and biochemical data, subjects will be randomly assigned to daily calorie restriction (CR) or intermittent calorie restriction (ICR),or control group without FA or BED for a period of 6 weeks. All Subjects will follow the standard regimen that includes restricted calories diet, detailed individualized balanced menu (either regular diet or time restricted diet) based on the subject's baseline body weight and height. Macronutrient distribution of the assigned diets will provide carbohydrate (55-60%), protein (15-20%), fat (<30%). Instructions and counseling will be provided to all subjects individually; and they will be monitored every two weeks by the researcher. Each participant will be evaluated and monitored separately, and all information obtained will be confidential. Daily calorie requirements will be calculated using the Harris benedict equation for each subject, taking into consideration the activity level. About 1100 kcal/day deficit from initial energy body needs will be applied for each woman, and the expected calories content of the weight-reducing diets, which will be between 1200-1500 kcal/ day.
Women: (REE= 447.593 + 3.098 x (Ht cm) + 9.247 x (Wt kg) - 4.330 x (Age)) To monitor and evaluated the adherence of participants to their diet, they will be provide daily food record sheet, these sheet will be reviewed and discussed with the researcher.
Overnight fasting blood samples will be withdrawn from all groups before and after 6 weeks of the dietary intervention trial. Each time, a licensed Phlebotomist will collect about 20 mL of blood from each woman in tubes containing EDTA as anticoagulant. Samples then will be centrifuged immediately for 20 minutes at 2500 g at 4°C and plasma will be collected in 1.5 mL micro tubes and stored at -80°C until they were analyzed. Blood sample preparation and centrifugation will be performed by a specialist at the nutritional counseling center, Irbid, Jordan. The blood samples then will be transported and stored at -20°C until analyses in a private laboratory. Plasma samples will be assayed for dopamine and serotonin levels using sensitive ELISA kits for the quantification of Dopamine and serotonin.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| food addiction and binge eating follow caloric reduced -intermitted fasting diet | Experimental | Behavioral: caloric reduced -intermitted fasting dietObese 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 comparator | Behavioral: Daily calorie restrictionObese women diagnosed with binge eating disorder and food addiction follow caloric restriction diet |
| binge eating disorder follow follow caloric reduced -intermitted fasting diet | Experimental | Behavioral: caloric reduced -intermitted fasting dietObese women diagnosed with binge eating disorder follow caloric reduced -intermitted fasting diet |
| binge eating disorder follow caloric restriction diet | Active comparator | Behavioral: Daily calorie restrictionObese women diagnosed with binge eating disorder follow a caloric restriction diet |
| obese women without food addiction and binge eating follow caloric restriction diet | Placebo comparator | Behavioral: Control groupObese women without eating disorder follow a caloric restriction diet |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Females,
- Aged between 20-40 yr,
- Premenopausal,
- BMI(>30 kg/m)
Key exclusion criteria (4 listed)
- Male
- Females aged <20-40< yr,
- Menopausal,
- BMI(<30 kg/m)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| caloric reduced -intermitted fasting dietAlso: Treatmentobese women with food addiction and binge eating follow intermittent calorie restriction diet ( time-restricted eating - typically 16 -hour fasting and 8-hour eating) | Behavioural | binge eating disorder follow follow caloric reduced -intermitted fasting diet, food addiction and binge eating follow caloric reduced -intermitted fasting diet |
| Daily calorie restrictionAlso: Active comparative treatmentobese women with food addiction and binge eating disorder follow a Daily calorie restriction diet | Behavioural | binge eating disorder follow caloric restriction diet, food addiction and binge eating follow caloric restriction diet |
| Control groupobese women without food addiction and binge eating disorder follow a Daily calorie restriction diet | Behavioural | obese women without food addiction and binge eating follow caloric restriction diet |
Primary outcome
Dopamine serum level
Time frame: Through study completion, an average of 1 year
The level of serum dopamine in ng/ml at both baseline and 6 weeks of follow up
Serotonin serum level
Time frame: Through study completion, an average of 1 year
The level of serum serotonin in ng/ml at both baseline and 6 weeks of follow up
food addiction disorder
Time frame: Through study completion, an average of 1 year
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.
binge eating disorder (BED)
Time frame: Through study completion, an average of 1 year
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2021.
- Background: PubMed 31487791Adams 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.
- Background: PubMed 9705020Ajlouni 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.
- Background: PubMed 23261515Allen 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.
- Background: PubMed 21999687Avena 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.
- Background: PubMed 28713531Bastani 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.
- Background: PubMed 20417658Bello 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.
- Background: PubMed 17370289Brownley 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.
- Background: PubMed 28438892Camandola 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.
- Background: PubMed 26683528Citrome 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.
- Background: PubMed 26094791da 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.
- Background: PubMed 27816464Davis 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.
- Individual participant dataSharing planned: No. The center (Jordan University hospital) where the study conducted emphasis of maintaining privacy and confidentiality of the participants' data
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rima H Mashal, Assoc. Prof study chair
University of Jordan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing caloric reduced -intermitted fasting diet and Daily calorie restriction in people with Eating Disorders and Intermittent Fasting, run by University of Jordan at 1 site in Jordan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Jordan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zainab A Zueter, phD (00692787123270, zainab.just@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dopamine serum level (time frame: Through study completion, an average of 1 year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04873648, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2021.