Metabolic SyndromeNCT03533881
Effects of Arom Digest Slim on Metabolic Profile and Food Behaviour in Overweight Persons
A study testing Arom Digest Slim and Nutritional changes in people with Metabolic Syndrome, run by SC Aromaarmony SRL at 1 site in Romania.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Metabolic Syndrome
- What is being tested?
- Arom Digest Slim and Nutritional changes
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteRomania
- Study dates
- 16 Apr 2018to 15 Apr 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- females 18 to 60 years old
Who cannot join
- cardiovascular, psychiatric and neurologic chronic conditions and medication
- acute conditions
- patients with hypersensitivity to any components of the product
Trial locations and contacts
1 site in 1 country.
Romania1 site, 1 recruiting
- Recruiting
Endocrinology Department
Cluj-Napoca, Cluj
Monica Goia-Socol, MD, 0740923197 ext. 004, monicagoiasocol@gmail.com
Cornelia Chaumont, psih, 0724269920 ext. 004, corneliadecuchaumont@yahoo.fr
About this study
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
The present study aims to evaluate the efficacy of Arom Digest Slim in facilitating weight reduction along with a series of minimal nutritional interventions.
Read the 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.
- Conditions
- Metabolic Syndrome
- Being tested
- Arom Digest Slim, Nutritional changes
- Keywords
- collagen, volatile oils, metabolic syndrome, insulin resistance
- Medical subject headings
- Metabolic Syndrome, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
Nutritional changesBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Arom Digest Slim and nutritional changes | Active comparator | Subjects take collagen and follow minimal nutritional changes. Receives: Dietary Supplement: Arom Digest Slim; Behavioral: Nutritional changes |
| Nutritional changes | Active comparator | Subjects only follow minimal nutritional changes Receives: Behavioral: Nutritional changes |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: baseline and 60 days
Change from Baseline Lipids at 60 days (Biochemical assessment)
total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides - serum level (mg/dl)
Measured: 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.
Measured: 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:
- 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
Measured: baseline and 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2018
- Study start16 Apr 2018
- Primary completion15 Feb 2019 (estimated)
- Study completion15 Apr 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Group 1: following minimal nutritional changes Group 2: following minimal nutritional changes and taking Arom Digest Slim
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SC Aromaarmony SRL
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Monica Goia-Socol, SC Aromaarmony SRL
- Investigators
- Monica Goia-Socol, MD, PhD, Principal investigator, Endocrinology Department, University of Medicine and Pharmacy Cluj-Napoca, Romania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03533881
- Sponsor's protocol ID
- Arom Digest Slim
- Status last verified
- May 2018
- First submitted
- 25 Apr 2018
- Last updated
- 23 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 28602994Subhan 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.
PubMed 28717410Lone 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.
PubMed 27071835Medagama 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.
PubMed 26475130Maenner 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.
PubMed 21357448Boschi 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.
PubMed 11359032
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03533881
- Acronym / sponsor ID
- Arom Digest Slim
- Conditions
- Metabolic Syndrome
- Keywords
- collagen, volatile oils, metabolic syndrome, insulin resistance
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- SC Aromaarmony SRLIndustry (pharma, biotech, devices)
- Study start
- 16 Apr 2018 (actual)
- Primary completion
- 15 Feb 2019 (estimated)
- Study completion
- 15 Apr 2019 (estimated)
- First posted
- 23 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Group 1: following minimal nutritional changes Group 2: following minimal nutritional changes and taking Arom Digest Slim
| Arm | Type | Receives |
|---|---|---|
| Arom Digest Slim and nutritional changes | Active comparator | Dietary Supplement: Arom Digest Slim, Behavioral: Nutritional changesSubjects take collagen and follow minimal nutritional changes. |
| Nutritional changes | Active comparator | Behavioral: Nutritional changesSubjects only follow minimal nutritional changes |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- females 18 to 60 years old
Key exclusion criteria (3 listed)
- cardiovascular, psychiatric and neurologic chronic conditions and medication
- acute conditions
- patients with hypersensitivity to any components of the product
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Arom Digest SlimArom 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 | Dietary supplement | Arom Digest Slim and nutritional changes |
| Nutritional changesEducation 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 | Behavioural | Arom Digest Slim and nutritional changes, Nutritional changes |
Primary outcome
Change from Baseline Insulin Resistance index (HOMA) at 60 days (Biochemical assessment)
Time frame: baseline and 60 days
calculated from serum level of glucose and insulin: HOMA-IR = (insulin (µU/mL) x glycemia (mg/dL))/405
Change from Baseline Lipids at 60 days (Biochemical assessment)
Time frame: baseline and 60 days
total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides - serum level (mg/dl)
Change from Baseline Food behavior at 60 days (Three Factor Eating Questionnaire 18 (TEFQ 18))
Time frame: baseline and 60 days
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.
Change from Baseline Bioimpedance parameters at 60 days (measured using InBody720 equipment)
Time frame: baseline and 60 days
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2018.
- Background: PubMed 28602994Lee 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.
- Background: PubMed 28717410Subhan 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.
- Background: PubMed 27071835Lone 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.
- Background: PubMed 26475130Medagama 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.
- Background: PubMed 21357448Maenner 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.
- Background: PubMed 11359032Boschi 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.
- Individual participant dataSharing planned: No
Related trials for Metabolic Syndrome
RecruitingObservational study
Defining the Natural History of Squamous Cell Carcinoma in Fanconi Anemia
Fanconi Anemia, Inherited Bone Marrow Failure Syndrome
Not yet recruitingPhase 2
Osilodrostat for Glycemic Control in Mild Autonomous Cortisol Secretion (MACS) With Difficult-To-Control Type 2 Diabetes - A Randomized, Double-Blind, Placebo-Controlled Phase 2 Study
Mild Autonomous Cortisol Secretion (MACS), Diabetes Mellitus (Type 2)
Active, not recruiting
Effects of Whole-body Electrical Muscle Stimulation Exercise on Adults With Neuromuscular Disease
Neuromuscular Diseases (NMD), Amyotrophic Lateral Sclerosis
Not yet recruitingObservational study
Clinical Genetics Branch Eligibility Screening Survey
Melanoma, Li-Fraumeni Syndrome
Not yet recruitingPhase 2
Effects of Meal Macronutrients on Postprandial Lipids
Nephrotic Syndrome, Lipodystrophy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Monica Goia-Socol, MD, PhD principal investigator
Endocrinology Department, University of Medicine and Pharmacy Cluj-Napoca, Romania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Arom Digest Slim and Nutritional changes in people with Metabolic Syndrome, run by SC Aromaarmony SRL at 1 site in Romania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Romania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Monica Goia-Socol, MD, PhD (0740923197 ext. 004, monicagoiasocol@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline Insulin Resistance index (HOMA) at 60 days (Biochemical assessment) (time frame: baseline and 60 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03533881, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2018.