Effects of Arom Digest Slim on Metabolic Profile and Food Behaviour in Overweight Persons

Study Overview
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Brief Summary
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The present study aims to evaluate the efficacy of Arom Digest Slim in facilitating weight reduction along with a series of minimal nutritional interventions.

Detailed Description
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Arom Digest Slim is a blend of fish collagen and essential oils. It will be administered in a group of overweight females wich also undertake minimal nutritional changes. The group will be compared with a group following only minimal nutritional changes.

Official Title
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Evaluation of Metabolic Effects and in Modulation of Food Behaviour of Arom Digest Slim Product in Association With Minimal Nutritional Changes in Overweight Patients

Conditions
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Metabolic Syndrome

Intervention / Treatment
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* Dietary Supplement: Arom Digest Slim
* Behavioral: Nutritional changes


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: females 18 to 60 years old Exclusion Criteria: cardiovascular, psychiatric and neurologic chronic conditions and medication acute conditions patients with hypersensitivity to any components of the product

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Group 1: following minimal nutritional changes Group 2: following minimal nutritional changes and taking Arom Digest Slim
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arom Digest Slim and nutritional changes<br>Subjects take collagen and follow minimal nutritional changes. | Dietary Supplement: Arom Digest Slim<br>* Arom Digest Slim is a dietary supplement approved in Romania by SNPMAPS, with notification number AA 10802/2017. It contains: hydrolyzed fish collagen (94,8 %) and volatile oils (5,2 %): Citrus paradisi (2,40 %), Citrus aurantifolia (1,24 %), Menta avensis (0,92 %), Cinamomum zeylanicum (0,56%) Patients take 4 grams of supplement per day; the supplement is dissolved in 750 ml water and drunk throughout the day<br>Behavioral: Nutritional changes<br>* Education to increase the fruits and vegetables, decrease refined carbohydrates, decrease high fat animal products, regulation of meal programme, increase water intake to at least 1,5 liters per day<br>|
| Active Comparator: Nutritional changes<br>Subjects only follow minimal nutritional changes | Behavioral: Nutritional changes<br>* Education to increase the fruits and vegetables, decrease refined carbohydrates, decrease high fat animal products, regulation of meal programme, increase water intake to at least 1,5 liters per day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline Insulin Resistance index (HOMA) at 60 days (Biochemical assessment) | calculated from serum level of glucose and insulin: HOMA-IR = (insulin (µU/mL) x glycemia (mg/dL))/405 | baseline and 60 days | 
| Change from Baseline Lipids at 60 days (Biochemical assessment) | total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides - serum level (mg/dl) | baseline and 60 days | 
| Change from Baseline Food behavior at 60 days (Three Factor Eating Questionnaire 18 (TEFQ 18)) | Food behavior questionnaire: Three Factor Eating Questionnaire 18 (TEFQ 18) Assessed parameters: Uncontrolled eating - minimal possible value 9, maximal possible value 54 points Cognitive restriction - minimal possible value 3, maximal possible value 12 points Emotional eating - minimal possible value 5, maximal possible value 24 points Higher values represent a worse outcome. Subscales are summed to compute a total score. | baseline and 60 days | 
| Change from Baseline Bioimpedance parameters at 60 days (measured using InBody720 equipment) | Bioimpedance using InBody720 equipment (Biospace Co., Ltd.) Assessed parameters: A. Body Composition Analysis (9 items): Intracellular Water, Extracellular Water, Protein Mass (kg), Mineral Mass (kg), Body Fat Mass (kg), Total Body Water, Soft Lean Mass (kg), Fat Free Mass (kg), Weight (kg) B. Muscle-Fat Analysis(3 items): Weight (kg), Skeletal Muscle Mass (kg), Body Fat Mass (kg) C. Obesity Diagnosis: Body Mass Index(BMI, kg/m2), Percent Body Fat (%), Waist-Hip Ratio D. Lean Balance (5 items): Right Arm (kg), Left Arm (kg), Trunk (kg), Right Leg (kg), Left Leg (kg) E. Visceral Fat Area: Norma l<100cm2 Over : 100 150cm2 Extremely over : >150cm2 F. Weight Control(4 items): Target Weight (kg), Weight Control(kg), Fat Control(kg), Muscle Control(kg) F. Fitness Score: The Fitness Score is an arbitrary score based on the measured muscle and fat mass for the motivation of the subjects. Under 70 : Weak Type 70 90 : NormalType Over 90 : Athletic Type | baseline and 60 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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collagen, volatile oils, metabolic syndrome, insulin resistance