Clinical trial NCT04873648: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Eating Disorders
Intermittent Fasting
Obesity
Keywords: Eating Disorders
Intermitted Fasting
Obesity
Dopamine
Serotonin
Lead sponsor: University of Jordan
Sponsor class: OTHER
First posted: 2021-05-05
Enrollment: 100
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Dopamine serum level
timeFrame: Through study completion, an average of 1 year
measure: Serotonin serum level
timeFrame: Through study completion, an average of 1 year
measure: food addiction disorder
timeFrame: Through study completion, an average of 1 year
measure: binge eating disorder (BED)
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Amman
country: Jordan
facility: Zainb zaiter clinic
Study officials:
affiliation: The University of Jordan
name: Rima H Mashal, Assoc. Prof
role: STUDY_CHAIR
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