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

Primary Purpose

Eating Disorders, Intermittent Fasting, Obesity

Status
Unknown status
Phase
Not Applicable
Locations
Jordan
Study Type
Interventional
Intervention
caloric reduced -intermitted fasting diet
Daily calorie restriction
Control group
Sponsored by
University of Jordan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Eating Disorders focused on measuring Eating Disorders, Intermitted Fasting, Obesity, Dopamine, Serotonin

Eligibility Criteria

20 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

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)

Sites / Locations

  • Zainb zaiter clinicRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Active Comparator

Experimental

Active Comparator

Placebo Comparator

Arm Label

food addiction and binge eating follow caloric reduced -intermitted fasting diet

food addiction and binge eating follow caloric restriction diet

binge eating disorder follow follow caloric reduced -intermitted fasting diet

binge eating disorder follow caloric restriction diet

obese women without food addiction and binge eating follow caloric restriction diet

Arm Description

Obese women diagnosed with binge eating disorder and food addiction follow caloric reduced -intermitted fasting diet

Obese women diagnosed with binge eating disorder and food addiction follow caloric restriction diet

Obese women diagnosed with binge eating disorder follow caloric reduced -intermitted fasting diet

Obese women diagnosed with binge eating disorder follow a caloric restriction diet

Obese women without eating disorder follow a caloric restriction diet

Outcomes

Primary Outcome Measures

Dopamine serum level
The level of serum dopamine in ng/ml at both baseline and 6 weeks of follow up
Serotonin serum level
The level of serum serotonin in ng/ml at both baseline and 6 weeks of follow up
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.
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)

Secondary Outcome Measures

Full Information

First Posted
April 27, 2021
Last Updated
September 27, 2021
Sponsor
University of Jordan
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1. Study Identification

Unique Protocol Identification Number
NCT04873648
Brief Title
Effect of Fasting and Calorie-Restricted Diets on Dopamine and Serotonin Levels Among Obese Women With BED and FA
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
June 20, 2021 (Actual)
Primary Completion Date
March 30, 2022 (Anticipated)
Study Completion Date
June 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Jordan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eating Disorders, Intermittent Fasting, Obesity
Keywords
Eating Disorders, Intermitted Fasting, Obesity, Dopamine, Serotonin

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
food addiction and binge eating follow caloric reduced -intermitted fasting diet
Arm Type
Experimental
Arm Description
Obese women diagnosed with binge eating disorder and food addiction follow caloric reduced -intermitted fasting diet
Arm Title
food addiction and binge eating follow caloric restriction diet
Arm Type
Active Comparator
Arm Description
Obese women diagnosed with binge eating disorder and food addiction follow caloric restriction diet
Arm Title
binge eating disorder follow follow caloric reduced -intermitted fasting diet
Arm Type
Experimental
Arm Description
Obese women diagnosed with binge eating disorder follow caloric reduced -intermitted fasting diet
Arm Title
binge eating disorder follow caloric restriction diet
Arm Type
Active Comparator
Arm Description
Obese women diagnosed with binge eating disorder follow a caloric restriction diet
Arm Title
obese women without food addiction and binge eating follow caloric restriction diet
Arm Type
Placebo Comparator
Arm Description
Obese women without eating disorder follow a caloric restriction diet
Intervention Type
Behavioral
Intervention Name(s)
caloric reduced -intermitted fasting diet
Other Intervention Name(s)
Treatment
Intervention Description
obese women with food addiction and binge eating follow intermittent calorie restriction diet ( time-restricted eating - typically 16 -hour fasting and 8-hour eating)
Intervention Type
Behavioral
Intervention Name(s)
Daily calorie restriction
Other Intervention Name(s)
Active comparative treatment
Intervention Description
obese women with food addiction and binge eating disorder follow a Daily calorie restriction diet
Intervention Type
Behavioral
Intervention Name(s)
Control group
Intervention Description
obese women without food addiction and binge eating disorder follow a Daily calorie restriction diet
Primary Outcome Measure Information:
Title
Dopamine serum level
Description
The level of serum dopamine in ng/ml at both baseline and 6 weeks of follow up
Time Frame
Through study completion, an average of 1 year
Title
Serotonin serum level
Description
The level of serum serotonin in ng/ml at both baseline and 6 weeks of follow up
Time Frame
Through study completion, an average of 1 year
Title
food addiction disorder
Description
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.
Time Frame
Through study completion, an average of 1 year
Title
binge eating disorder (BED)
Description
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)
Time Frame
Through study completion, an average of 1 year

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
The most affected group with obesity and may have food Addiction and/or binge eating disorders
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zainab A Zueter, phD
Phone
00692787123270
Email
zainab.just@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Rima H Mashal, Assoc. Prof
Phone
00692795853769
Email
Rima@ju.edu.jo
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rima H Mashal, Assoc. Prof
Organizational Affiliation
The University of Jordan
Official's Role
Study Chair
Facility Information:
Facility Name
Zainb zaiter clinic
City
Amman
Country
Jordan
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
The center (Jordan University hospital) where the study conducted emphasis of maintaining privacy and confidentiality of the participants' data
Citations:
PubMed Identifier
31487791
Citation
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Results Reference
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PubMed Identifier
9705020
Citation
Ajlouni 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.
Results Reference
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PubMed Identifier
23261515
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.
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PubMed Identifier
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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. doi: 10.2174/1874473711104030133.
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PubMed Identifier
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Citation
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Effect of Fasting and Calorie-Restricted Diets on Dopamine and Serotonin Levels Among Obese Women With BED and FA

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