Clinical trial NCT03533881: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Metabolic Syndrome
Keywords: collagen
volatile oils
metabolic syndrome
insulin resistance
Lead sponsor: SC Aromaarmony SRL
Sponsor class: INDUSTRY
First posted: 2018-05-23
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Group 1: following minimal nutritional changes Group 2: following minimal nutritional changes and taking Arom Digest Slim
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Change from Baseline Insulin Resistance index (HOMA) at 60 days (Biochemical assessment)
timeFrame: baseline and 60 days
measure: Change from Baseline Lipids at 60 days (Biochemical assessment)
timeFrame: baseline and 60 days
measure: Change from Baseline Food behavior at 60 days (Three Factor Eating Questionnaire 18 (TEFQ 18))
timeFrame: baseline and 60 days
measure: Change from Baseline Bioimpedance parameters at 60 days (measured using InBody720 equipment)
timeFrame: baseline and 60 days
Secondary outcomes:
Other outcomes:
Locations:
city: Cluj-Napoca
country: Romania
facility: Endocrinology Department
state: Cluj
Study officials:
affiliation: Endocrinology Department, University of Medicine and Pharmacy Cluj-Napoca, Romania
name: Monica Goia-Socol, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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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.
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.
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.
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.
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.