Back to resultsEffects of Arom Digest Slim on Metabolic Profile and Food Behaviour in Overweight Persons
Primary Purpose
Metabolic Syndrome
Status
Unknown status
Phase
Not Applicable
Locations
Romania
Study Type
Interventional
Intervention
Arom Digest Slim
Nutritional changes
Sponsored by
About this trial
This is an interventional supportive care trial for Metabolic Syndrome focused on measuring collagen, volatile oils, metabolic syndrome, insulin resistance
Eligibility 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
Sites / Locations
- Endocrinology DepartmentRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Arom Digest Slim and nutritional changes
Nutritional changes
Arm Description
Subjects take collagen and follow minimal nutritional changes.
Subjects only follow minimal nutritional changes
Outcomes
Primary Outcome Measures
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
Change from Baseline Lipids at 60 days (Biochemical assessment)
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))
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)
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03533881
Brief Title
Effects of Arom Digest Slim on Metabolic Profile and Food Behaviour in Overweight Persons
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Unknown status
Study Start Date
April 16, 2018 (Actual)
Primary Completion Date
February 15, 2019 (Anticipated)
Study Completion Date
April 15, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
SC Aromaarmony SRL
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome
Keywords
collagen, volatile oils, metabolic syndrome, insulin resistance
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Group 1: following minimal nutritional changes Group 2: following minimal nutritional changes and taking Arom Digest Slim
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Arom Digest Slim and nutritional changes
Arm Type
Active Comparator
Arm Description
Subjects take collagen and follow minimal nutritional changes.
Arm Title
Nutritional changes
Arm Type
Active Comparator
Arm Description
Subjects only follow minimal nutritional changes
Intervention Type
Dietary Supplement
Intervention Name(s)
Arom Digest Slim
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
Nutritional changes
Intervention Description
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 Measure Information:
Title
Change from Baseline Insulin Resistance index (HOMA) at 60 days (Biochemical assessment)
Description
calculated from serum level of glucose and insulin: HOMA-IR = (insulin (µU/mL) x glycemia (mg/dL))/405
Time Frame
baseline and 60 days
Title
Change from Baseline Lipids at 60 days (Biochemical assessment)
Description
total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides - serum level (mg/dl)
Time Frame
baseline and 60 days
Title
Change from Baseline Food behavior at 60 days (Three Factor Eating Questionnaire 18 (TEFQ 18))
Description
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.
Time Frame
baseline and 60 days
Title
Change from Baseline Bioimpedance parameters at 60 days (measured using InBody720 equipment)
Description
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
Time Frame
baseline and 60 days
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Monica Goia-Socol, MD, PhD
Phone
0740923197
Ext
004
Email
monicagoiasocol@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Cornelia Chaumont, psih
Phone
0724269920
Ext
004
Email
corneliadecuchaumont@yahoo.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Monica Goia-Socol, MD, PhD
Organizational Affiliation
Endocrinology Department, University of Medicine and Pharmacy Cluj-Napoca, Romania
Official's Role
Principal Investigator
Facility Information:
Facility Name
Endocrinology Department
City
Cluj-Napoca
State/Province
Cluj
Country
Romania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Monica Goia-Socol, MD
Phone
0740923197
Ext
004
Email
monicagoiasocol@gmail.com
First Name & Middle Initial & Last Name & Degree
Cornelia Chaumont, psih
Phone
0724269920
Ext
004
Email
corneliadecuchaumont@yahoo.fr
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
28602994
Citation
Lee EJ, Hur J, Ham SA, Jo Y, Lee S, Choi MJ, Seo HG. Fish collagen peptide inhibits the adipogenic differentiation of preadipocytes and ameliorates obesity in high fat diet-fed mice. Int J Biol Macromol. 2017 Nov;104(Pt A):281-286. doi: 10.1016/j.ijbiomac.2017.05.151. Epub 2017 Jun 9.
Results Reference
background
PubMed Identifier
28717410
Citation
Subhan F, Kang HY, Lim Y, Ikram M, Baek SY, Jin S, Jeong YH, Kwak JY, Yoon S. Fish Scale Collagen Peptides Protect against CoCl2/TNF-alpha-Induced Cytotoxicity and Inflammation via Inhibition of ROS, MAPK, and NF-kappaB Pathways in HaCaT Cells. Oxid Med Cell Longev. 2017;2017:9703609. doi: 10.1155/2017/9703609. Epub 2017 Jun 22.
Results Reference
background
PubMed Identifier
27071835
Citation
Lone J, Yun JW. Monoterpene limonene induces brown fat-like phenotype in 3T3-L1 white adipocytes. Life Sci. 2016 May 15;153:198-206. doi: 10.1016/j.lfs.2016.04.010. Epub 2016 Apr 9.
Results Reference
background
PubMed Identifier
26475130
Citation
Medagama AB. The glycaemic outcomes of Cinnamon, a review of the experimental evidence and clinical trials. Nutr J. 2015 Oct 16;14:108. doi: 10.1186/s12937-015-0098-9.
Results Reference
background
PubMed Identifier
21357448
Citation
Maenner K, Vahjen W, Simon O. Studies on the effects of essential-oil-based feed additives on performance, ileal nutrient digestibility, and selected bacterial groups in the gastrointestinal tract of piglets. J Anim Sci. 2011 Jul;89(7):2106-12. doi: 10.2527/jas.2010-2950. Epub 2011 Feb 25.
Results Reference
background
PubMed Identifier
11359032
Citation
Boschi V, Iorio D, Margiotta N, D'Orsi P, Falconi C. The three-factor eating questionnaire in the evaluation of eating behaviour in subjects seeking participation in a dietotherapy programme. Ann Nutr Metab. 2001;45(2):72-7. doi: 10.1159/000046709.
Results Reference
background
Learn more about this trial
Effects of Arom Digest Slim on Metabolic Profile and Food Behaviour in Overweight Persons
We'll reach out to this number within 24 hrs