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

Metabolic Syndrome Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03533881
• Other study ID #: Arom Digest Slim
• Status: Recruiting
• Phase: N/A
• Start date: April 16, 2018
• Est. completion date: April 15, 2019

Study information

• Verified date: May 2018
• Source: SC Aromaarmony SRL
• Contact: Monica Goia-Socol, MD, PhD
• Phone: 0740923197
• Email: monicagoiasocol[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: April 15, 2019
• Est. primary completion date: February 15, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Metabolic Syndrome
• Metabolic Syndrome X
• Overweight

Intervention

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

Locations

Country	Name	City	State
Romania	Endocrinology Department	Cluj-Napoca	Cluj

Sponsors (1)

Lead Sponsor	Collaborator
SC Aromaarmony SRL

Country where clinical trial is conducted

Romania, 

References & Publications (6)

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. — View 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. — View 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. — View 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. — View 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. Review. — View 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 CoCl(2)/TNF-a-Induced Cytotoxicity and Inflammation via Inhibition of ROS, MAPK, and NF-?B Pathways in HaCaT Cells. Oxid Med Cell Longev. 2017;2017:9703609. doi: 10.1155/2017/9703609. Epub 2017 Jun 22. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Change from Baseline Lipids at 60 days (Biochemical assessment)	total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides - serum level (mg/dl)	baseline and 60 days
Primary	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
Primary	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	baseline and 60 days