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

May 22, 2018 updated by: Monica Goia-Socol, SC Aromaarmony SRL

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
baseline and 60 days
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)
baseline and 60 days
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.
baseline and 60 days
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
baseline and 60 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

SC Aromaarmony SRL

Investigators

  • Principal Investigator: Monica Goia-Socol, MD, PhD, Endocrinology Department, University of Medicine and Pharmacy Cluj-Napoca, Romania

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 16, 2018

Primary Completion (Anticipated)

February 15, 2019

Study Completion (Anticipated)

April 15, 2019

Study Registration Dates

First Submitted

April 25, 2018

First Submitted That Met QC Criteria

May 22, 2018

First Posted (Actual)

May 23, 2018

Study Record Updates

Last Update Posted (Actual)

May 23, 2018

Last Update Submitted That Met QC Criteria

May 22, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Arom Digest Slim

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Metabolic Syndrome

Clinical Trials on Arom Digest Slim

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Sri Lanka

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe