Evaluation of the efficacy of a food supplement in reducing joint discomfort

ISRCTN	ISRCTN62826698
DOI	https://doi.org/10.1186/ISRCTN62826698
Clinical Study Protocol Number	EC_NT0000372
Study Code_Order	H.E.HU.HV.NJS00.090.00.00_NT0001506-25
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: Musculoskeletal Diseases

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 Enrico Spadafora
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

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 in reducing joint discomfort: 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 reducing joint discomfort. The secondary objective of this study is to evaluate the efficacy and pleasantness of the product as perceived by the subjects.
Ethics approval(s)	Approved 23/12/2025, International Ethics and Integrity Committee (Via Per Garbagnate 61, Lainate (MI), Lainate, 20045, Italy; +39 3783037302; secretariat@ieicomittee.com), ref: Rif IC10 A
Health condition(s) or problem(s) studied	Healthy subjects with mild to moderate joint discomfort, overweight and who practise sports.
Intervention	The active product will be tested in two formulations containing different amounts of Sodium Hyaluronate (ExceptionHyal®Jump - one with twice the dose of the other), 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: one third of the subjects will be allocated to the first formulation of the active product, one third of the subjects will be allocated to the second formulation of the active product and one third 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 28 days ± 2 days as follows: one capsule per day in the morning, with a glass of water, either before or after meals.
Intervention type	Supplement
Primary outcome measure(s)	Passive Range of Motion (PROM) measured using goniometer (°) at baseline, 10 and 28 days of product use. Active Range of Motion (AROM) measured using goniometer (°) at baseline, 10 and 28 days of product use. Discomfort on palpation measured using Numerical Rating Scale (NRS) from 0 to 10, where 0 indicates the absence of discomfort, and 10 indicates severe discomfort at baseline, 10 and 28 days of product use. Perceived joint discomfort measured using Numerical Rating Scale (NRS), where 0 represents "no discomfort" and 10 indicates the "worst discomfort imaginable” at baseline, 10 and 28 days of product use.
Key secondary outcome measure(s)	Efficacy perceived and the pleasantness of the product measured using self-evaluation questionnaire (polytomous question with four possible answers) at 28 days of product use.
Completion date	24/04/2026

Eligibility

Participant type(s)
Age group	Adult
Lower age limit	25 Years
Upper age limit	55 Years
Sex	All
Target sample size at registration	99
Key inclusion criteria	1. Healthy male and female subjects 2. Subjects of Caucasian ethnicity 3. Subjects aged between 25 and 55 years (extremes included) 4. Subjects with mild to moderate joint discomfort (not related to any underlying pathology) * 5. Subjects who are overweight 6. Subjects who practice sports* 7. Subjects registered with national health service 8. Subjects certifying the truthfulness of the personal data disclosed to the Principal Investigator or designated personnel 9. Subjects able to understand the language used in the investigation centre and the information given by the Principal Investigator or designated personnel 10. 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 11. Subjects who commit not to change their daily routine or lifestyle during the study **** 12. 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 13. Subjects informed about the test procedures who have signed a consent form and privacy agreement * Discomfort on palpation and perceived joint discomfort from 4 to 8 (extremes included) BMI between 25 kg/m² and 29.9 kg/m². According to the World Health Organization (WHO) BMI Classification. * 45 to 60 minutes of non-competitive training, 1 to 2 times per week. Participants will avoid excessive strain as instructed by the physiotherapist on the joint causing the greatest discomfort at baseline visit, which will be the joint investigated throughout the study. **** Subjects will keep a diary to ensure that they do not change their exercise and eating habits during the study.
Key exclusion criteria	1. Subjects who do not meet the inclusion criteria 2. Female subjects who are postmenopausal 3. Subjects with any acute, chronic, or progressive disease or condition that may interfere with the study data or that the Principal 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 Principal 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). * Including musculoskeletal disease, skeletal neuromuscular injuries, autoimmune diseases **** Including Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), Corticosteroids, Pain medications taken daily or on a regular basis
Date of first enrolment	07/01/2026
Date of final enrolment	06/03/2026

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.