NCT03533881

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2018

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 16, 2018

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

April 25, 2018

Completed
28 days until next milestone

First Posted

Study publicly available on registry

May 23, 2018

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2019

Completed
Last Updated

May 23, 2018

Status Verified

May 1, 2018

Enrollment Period

10 months

First QC Date

April 25, 2018

Last Update Submit

May 22, 2018

Conditions

Metabolic Syndrome

Keywords

collagenvolatile oilsmetabolic syndromeinsulin resistance

Outcome Measures

Primary Outcomes (4)

  • 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

    baseline and 60 days

Study Arms (2)

Arom Digest Slim and nutritional changes

ACTIVE COMPARATOR

Subjects take collagen and follow minimal nutritional changes.

Dietary Supplement: Arom Digest SlimBehavioral: Nutritional changes

Nutritional changes

ACTIVE COMPARATOR

Subjects only follow minimal nutritional changes

Behavioral: Nutritional changes

Interventions

Arom Digest SlimDIETARY_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

Arom Digest Slim and nutritional changes
Nutritional changesBEHAVIORAL

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

Arom Digest Slim and nutritional changesNutritional changes

Eligibility Criteria

Age18 Years - 60 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • females 18 to 60 years old

You may not qualify if:

  • cardiovascular, psychiatric and neurologic chronic conditions and medication
  • acute conditions
  • patients with hypersensitivity to any components of the product

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Endocrinology Department

Cluj-Napoca, Cluj, Romania

RECRUITING

Related Publications (6)

  • 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.

    PMID: 28602994BACKGROUND

  • 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.

    PMID: 28717410BACKGROUND

  • 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.

    PMID: 27071835BACKGROUND

  • 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.

    PMID: 26475130BACKGROUND

  • 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.

    PMID: 21357448BACKGROUND

  • 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.

    PMID: 11359032BACKGROUND

MeSH Terms

Conditions

Metabolic SyndromeInsulin Resistance

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Monica Goia-Socol, MD, PhD

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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Monica Goia-Socol, MD, PhD

CONTACT

0740923197monicagoiasocol@gmail.com

Cornelia Chaumont, psih

CONTACT

0724269920corneliadecuchaumont@yahoo.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Group 1: following minimal nutritional changes Group 2: following minimal nutritional changes and taking Arom Digest Slim
Sponsor Type
INDUSTRY
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assist. Prof. Dr. Monica Goia-Socol, MD, PhD

Study Record Dates

First Submitted

April 25, 2018

First Posted

May 23, 2018

Study Start

April 16, 2018

Primary Completion

February 15, 2019

Study Completion

April 15, 2019

Last Updated

May 23, 2018

Record last verified: 2018-05

Data Sharing

IPD Sharing
Will not share

Locations

RO(1)