Metabolic Syndrome
Conditions
Keywords
collagen, volatile oils, metabolic syndrome, insulin resistance
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.
Interventions
BEHAVIORALNutritional 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
DIETARY_SUPPLEMENTArom 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
Sponsors
SC Aromaarmony SRL
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
Group 1: following minimal nutritional changes Group 2: following minimal nutritional changes and taking Arom Digest Slim
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 60 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 Lipids at 60 days (Biochemical assessment) | baseline and 60 days | total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides - serum level (mg/dl) |
| 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 |
Countries
Romania
Contacts
Primary ContactMonica Goia-Socol, MD, PhD
Backup ContactCornelia Chaumont, psih
Outcome results
None listed