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The present study aims to evaluate the efficacy of Arom Digest Slim in facilitating weight reduction along with a series of minimal nutritional interventions.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arom Digest Slim and nutritional changes | Active Comparator | Subjects take collagen and follow minimal nutritional changes. |
|
| Nutritional changes | Active Comparator | Subjects only follow minimal nutritional changes |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Arom Digest Slim | Dietary Supplement | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | baseline and 60 days |
| Change from Baseline Lipids at 60 days (Biochemical assessment) | 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)) | 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) | 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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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Monica Goia-Socol, MD, PhD | Contact | 0740923197 | 004 | monicagoiasocol@gmail.com |
| Cornelia Chaumont, psih | Contact | 0724269920 | 004 | corneliadecuchaumont@yahoo.fr |
| Name | Affiliation | Role |
|---|---|---|
| Monica Goia-Socol, MD, PhD | Endocrinology Department, University of Medicine and Pharmacy Cluj-Napoca, Romania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Endocrinology Department | Recruiting | Cluj-Napoca | Cluj | Romania |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28602994 | Background | 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. | |
| 28717410 | Background |
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| ID | Term |
|---|---|
| D024821 | Metabolic Syndrome |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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Group 1: following minimal nutritional changes Group 2: following minimal nutritional changes and taking Arom Digest Slim
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| Nutritional changes | Behavioral | 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 |
|
| baseline and 60 days |
| 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. |
| 27071835 | Background | 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. |
| 26475130 | Background | 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. |
| 21357448 | Background | 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. |
| 11359032 | Background | 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. |