Evaluation of the efficacy of a food supplement for subjects with metabolic syndrome

ISRCTN	ISRCTN10195062
DOI	https://doi.org/10.1186/ISRCTN10195062
Clinical Study Protocol Number	EC_NT0000414/25
Study Code_Order	H.E.HU.HV.NMS00.060.03.00_NT0001644-25
Sponsor	ROELMI HPC S.R.L., Via Celeste Milani 24/26 – 21040 Origgio (VA), Italy
Funder	ROELMI HPC. S.R.L.

Submission date: 03/02/2026
Registration date: 04/02/2026
Last edited: 03/02/2026

Recruitment status: Recruiting
Overall study status: Ongoing
Condition category: Nutritional, Metabolic, Endocrine

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Archiropita Curti
Principal investigator

via F. Todaro 20/22, Rende (CS)
Rende
87036
Italy

Phone	+ 39 09841735511
Email	nutratech@nutratechtesting.com

Dr Roberta Villa
Public, Scientific

Viale Indipendenza, 11, Pavia (PV)
Pavia
27100
Italy

Phone	+39 038225504
Email	roberta.villa@complifegroup.com

Dr Eleonora Spartà
Scientific, Public

Viale Indipendenza, 11, Pavia (PV)
Pavia
27100
Italy

Phone	+39 038225504
Email	eleonora.sparta@complifegroup.com

Study information

Primary study design	Interventional
Allocation	Randomized controlled trial
Masking	Blinded (masking used)
Control	Placebo
Assignment	Parallel
Purpose	Treatment, Efficacy
Scientific title	Clinical evaluation of the efficacy of a food supplement for subjects with metabolic syndrome: a randomized, double-blind, parallel-group, placebo-controlled study
Study objectives	The primary objective of this study is to evaluate the efficacy of the product in improving selected parameters related to metabolic syndrome. The secondary objective of this study is to evaluate the efficacy of the product in improving selected metabolic indices and inflammatory status to metabolic syndrome.
Ethics approval(s)	Approved 28/01/2026, International Ethics and Integrity Committee (Via Per Garbagnate 61, Lainate (MI), Lainate, 20045, Italy; +39 3783037302; secretariat@ieicomittee.com), ref: Rif. IC0014 A
Health condition(s) or problem(s) studied	Healthy subjects with overweight or mild obesity and with metabolic syndrome.
Intervention	The active product is a food supplement containing Hops extract (Humulus Lupulus L.), while the placebo contains the same excipients without the active ingredients. A restricted randomization list will be generated by an independent technician using the appropriate algorithm ("Wei’surn") of the PASS 11 software (PASS, LLC. Kaysville, UT, USA) and stored in a secure location. The Principal Investigator or designated personnel will dispense the products according to the generated randomization list: half of the subjects will be allocated to the active product and half of the subjects will be allocated to a placebo. The study will be double-blind, meaning that subjects, Principal Investigator and collaborators are kept masked to products assignment. The products will be supplied in the same packaging with no obvious differences between them. Subjects will take the assigned treatment for 84 days ± 2 days as follows: one capsule per day, in the morning, on an empty stomach, with a glass of water.
Intervention type	Supplement
Primary outcome measure(s)	Waist circumference measured using a tape (cm) at baseline, 56 and 84 days. Body weight measured using a scale (kg) at baseline, 56 and 84 days. Body Mass Index (BMI) measured using the formula: BMI = weight / height^2 at baseline, 56 and 84 days. Total cholesterol (TC) measured using blood analysis (mg/dl) at baseline, 56 and 84 days. High-density lipoprotein cholesterol (HDL-C) measured using blood analysis (mg/dl) at baseline, 56 and 84 days. Low-density lipoprotein cholesterol (LDL-C) measured using blood analysis (mg/dl) at baseline, 56 and 84 days. Triglycerides (TG) measured using blood analysis (mg/dl) at baseline, 56 and 84 days. Fasting glucose (FG) measured using blood analysis (mg/dl) at baseline, 56 and 84 days. Fasting Insulin (FI) measured using blood analysis (µU/ml) at baseline, 56 and 84 days. Glycated hemoglobin (HbA1c) measured using blood analysis (% or mmol/l) at baseline, 56 and 84 days.
Key secondary outcome measure(s)	HOMA-IR (Homeostasis Model Assessment of Insulin Resistance) measured using a specific mathematical formula at baseline, 56 and 84 days. Visceral Adiposity Index (VAI) measured using a specific mathematical formula at baseline, 56 and 84 days. High-sensitivity C-Reactive Protein (hs-CRP) measured using blood analysis at baseline, 56 and 84 days.
Completion date	29/05/2026

Eligibility

Participant type(s)
Age group	Adult
Lower age limit	18 Years
Upper age limit	64 Years
Sex	All
Target sample size at registration	66
Key inclusion criteria	1. Healthy male and female subjects 2. Subjects of Caucasian ethnicity 3. Subjects aged between 18 and 64 years (extremes included) 4. Subjects with overweight or mild obesity * 5. Subjects with metabolic syndrome 6. Subjects registered with national health service 7. Subjects certifying the truthfulness of the personal data disclosed to the Principal Investigator or designated Personnel 8. Subjects able to understand the language used in the investigation center and the information given by the Principal Investigator or designated personnel 9. Subjects able to respect the instructions given by the Principal Investigator or designated personnel as well as able to respect the study constraints and specific requirements 10. Subjects who commit not to change their daily routine or lifestyle during the study* 11. Subjects on stable pharmacological therapy (except for the pharmacological therapy in the non-inclusion criteria) for at least one month without any changes expected or planned during the study 12. Subjects informed about the test procedures who have signed a consent form and privacy agreement. * At the recruitment, BMI between 25 kg/m² and 34.9 kg/m² (overweight and obesity class I). According to the World Health Organization (WHO) BMI Classification According to the International Diabetes Federation (IDF). At least three out of five required: 1. Large waist circumference (≥ 94 cm for males and ≥ 80 cm for females) 2. Low HDL cholesterol levels (<40 mg/dl for males and <50 mg/dl for females) 3. High triglyceride levels (≥ 150 mg/dl) 4. High fasting glucose levels (≥ 100 mg/dl) 5. High blood pressure (≥ 130/85 mmHg) * Subjects will maintain a weekly diary to record their dietary habits and physical activity
Key exclusion criteria	1. Subjects who do not meet the inclusion criteria 2. Female subjects who consume ≥ 140 g/week of alcohol and male subjects who consume ≥ 210 g/week of alcohol** 3. Subjects with any acute, chronic, or progressive disease or condition that may interfere with the study data or that the investigator considers dangerous to the subject or incompatible with the requirements of the study* 4. Subjects participating or planning to participate in other clinical trials 5. Subjects who participated in a similar study without respecting an adequate washout period (at least one month) 6. Subjects that have food intolerances or food allergies to ingredients of the study product 7. Subjects under pharmacological treatments that are considered incompatible with the study requirement by the investigator ** 8. Subjects who are currently using food supplement(s) and/or products with the same activity as the study product, or who haven't observed an adequate washout period (at least one month) 9. Subjects admitted to a health or social facility 10. Subjects planning a hospitalization during the study 11. Subjects not able to be contacted in case of emergency 12. Subjects deprived of freedom by administrative or legal decision or under guardianship 13. Subjects who have or have had a history of alcohol or drug addiction 14. Subjects with eating disorders (i.e. bulimia, psychogenic eating disorders, etc.) 15. Subject breastfeeding, pregnant or not willing to take necessary precautions to avoid pregnancy during the study (for the women of childbearing potential) According to the American Association for the Study of Liver Diseases guidelines for nonalcoholic fatty liver disease * Including severe hepatic or kidney disease, serious infections, and malignancies **** Including medications to manage blood glucose levels (e.g., metformin, sulfonylureas, DPP-4 Inhibitors, GLP-1 Agonists), lipid disorders (e.g., statins, fibrates, niacin), high blood pressure (e.g., ACE Inhibitors, Angiotensin II Receptor Blockers, Beta-Blockers, Calcium Channel Blockers), as well as treatments for weight control and any food supplements intended for metabolic syndrome (MetS). Corticosteroids, antidepressants, antipsychotics
Date of first enrolment	28/01/2026
Date of final enrolment	09/02/2026

Locations

Countries of recruitment

Italy

Study participating centre

Nutratech S.r.l.

Via Francesco Todaro, 20/22, Rende (CS)
Rende
87036
Italy

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not expected to be made available
IPD sharing plan

Editorial Notes

03/02/2026: Trial's existence confirmed by International Ethics and Integrity Committee.