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

Not Applicable

• Conditions: Metabolic Syndrome
• Interventions: Dietary Supplement: Arom Digest Slim; Behavioral: Nutritional changes

• Registration Number: NCT03533881
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2018-04-16
• Study First Submitted: 2018-04-25
• Status Verified: 2018-05
• Study First Submitted QC: 2018-05-22
• Last Update Submitted: 2018-05-22
• Study First Posted: 2018-05-23
• Last Update Posted: 2018-05-23
• Primary Completion: 2019-02-15
• Study Completion: 2019-04-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arom Digest Slim and nutritional changes	Arom Digest Slim	Subjects take collagen and follow minimal nutritional changes.
Arom Digest Slim and nutritional changes	Nutritional changes	Subjects take collagen and follow minimal nutritional changes.
Nutritional changes	Nutritional changes	Subjects only follow minimal nutritional changes

Primary Outcome Measures

Name	Time	Method
Change from Baseline Lipids at 60 days (Biochemical assessment)	baseline and 60 days	total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides - serum level (mg/dl)
Change from Baseline Insulin Resistance index (HOMA) at 60 days (Biochemical assessment)	baseline and 60 days	calculated from serum level of glucose and insulin: HOMA-IR = (insulin (µU/mL) x glycemia (mg/dL))/405
Change from Baseline Food behavior at 60 days (Three Factor Eating Questionnaire 18 (TEFQ 18))	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.
Change from Baseline Bioimpedance parameters at 60 days (measured using InBody720 equipment)	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

Trial Locations

Locations (1)

Endocrinology Department; 🇷🇴 Cluj-Napoca, Cluj, Romania