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

NCT ID: NCT03533881

Last Updated: 2018-05-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-16

Study Completion Date

2019-04-15

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Metabolic Syndrome

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Group 1: following minimal nutritional changes Group 2: following minimal nutritional changes and taking Arom Digest Slim
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Arom Digest Slim and nutritional changes

Subjects take collagen and follow minimal nutritional changes.

Group Type ACTIVE_COMPARATOR

Arom Digest Slim

Intervention Type 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

Nutritional changes

Intervention Type 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

Nutritional changes

Subjects only follow minimal nutritional changes

Group Type ACTIVE_COMPARATOR

Nutritional changes

Intervention Type 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

Interventions

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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

Intervention Type DIETARY_SUPPLEMENT

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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SC Aromaarmony SRL

INDUSTRY

Sponsor Role lead

Responsible Party

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Monica Goia-Socol

Assist. Prof. Dr. Monica Goia-Socol, MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Monica Goia-Socol, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Endocrinology Department, University of Medicine and Pharmacy Cluj-Napoca, Romania

Locations

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Endocrinology Department

Cluj-Napoca, Cluj, Romania

Site Status RECRUITING

Countries

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Romania

Central Contacts

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Monica Goia-Socol, MD, PhD

Role: CONTACT

0740923197 ext. 004

Cornelia Chaumont, psih

Role: CONTACT

0724269920 ext. 004

Facility Contacts

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Monica Goia-Socol, MD

Role: primary

0740923197 ext. 004

Cornelia Chaumont, psih

Role: backup

0724269920 ext. 004

References

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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.

Reference Type BACKGROUND
PMID: 28602994 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28717410 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27071835 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26475130 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21357448 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11359032 (View on PubMed)

Other Identifiers

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Arom Digest Slim

Identifier Type: -

Identifier Source: org_study_id

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