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

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ClinicalTrials.gov Identifier: NCT03533881
Recruitment Status : Recruiting
First Posted : May 23, 2018
Last Update Posted : May 23, 2018
Sponsor:
Information provided by (Responsible Party):
Monica Goia-Socol, SC Aromaarmony SRL

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

Condition or disease Intervention/treatment Phase
Metabolic Syndrome Dietary Supplement: Arom Digest Slim Behavioral: Nutritional changes Not Applicable

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Group 1: following minimal nutritional changes Group 2: following minimal nutritional changes and taking Arom Digest Slim
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Evaluation of Metabolic Effects and in Modulation of Food Behaviour of Arom Digest Slim Product in Association With Minimal Nutritional Changes in Overweight Patients
Actual Study Start Date : April 16, 2018
Estimated Primary Completion Date : February 15, 2019
Estimated Study Completion Date : April 15, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Arom Digest Slim and nutritional changes
Subjects take collagen and follow minimal nutritional changes.
Dietary Supplement: Arom Digest Slim

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


Behavioral: Nutritional changes
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

Active Comparator: Nutritional changes
Subjects only follow minimal nutritional changes
Behavioral: Nutritional changes
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




Primary Outcome Measures :
  1. Change from Baseline Insulin Resistance index (HOMA) at 60 days (Biochemical assessment) [ Time Frame: baseline and 60 days ]
    calculated from serum level of glucose and insulin: HOMA-IR = (insulin (µU/mL) x glycemia (mg/dL))/405

  2. Change from Baseline Lipids at 60 days (Biochemical assessment) [ Time Frame: baseline and 60 days ]
    total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides - serum level (mg/dl)

  3. Change from Baseline Food behavior at 60 days (Three Factor Eating Questionnaire 18 (TEFQ 18)) [ Time Frame: baseline and 60 days ]

    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.


  4. Change from Baseline Bioimpedance parameters at 60 days (measured using InBody720 equipment) [ Time Frame: baseline and 60 days ]

    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




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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03533881


Contacts
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Contact: Monica Goia-Socol, MD, PhD 0740923197 ext 004 monicagoiasocol@gmail.com
Contact: Cornelia Chaumont, psih 0724269920 ext 004 corneliadecuchaumont@yahoo.fr

Locations
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Romania
Endocrinology Department Recruiting
Cluj-Napoca, Cluj, Romania
Contact: Monica Goia-Socol, MD    0740923197 ext 004    monicagoiasocol@gmail.com   
Contact: Cornelia Chaumont, psih    0724269920 ext 004    corneliadecuchaumont@yahoo.fr   
Sponsors and Collaborators
SC Aromaarmony SRL
Investigators
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Principal Investigator: Monica Goia-Socol, MD, PhD Endocrinology Department, University of Medicine and Pharmacy Cluj-Napoca, Romania

Publications:
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Responsible Party: Monica Goia-Socol, Assist. Prof. Dr. Monica Goia-Socol, MD, PhD, SC Aromaarmony SRL
ClinicalTrials.gov Identifier: NCT03533881     History of Changes
Other Study ID Numbers: Arom Digest Slim
First Posted: May 23, 2018    Key Record Dates
Last Update Posted: May 23, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Keywords provided by Monica Goia-Socol, SC Aromaarmony SRL:
collagen
volatile oils
metabolic syndrome
insulin resistance

Additional relevant MeSH terms:
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Overweight
Metabolic Syndrome
Body Weight
Signs and Symptoms
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases