DyslipidaemiaNCT07492264
Evaluation of Food Supplementation in Subjects With Suboptimal Levels of LDL Cholesterol
A study testing NUT2 in people with Dyslipidaemia, run by Cooper Consumer Health at 1 site in Italy.
Trial summary
This randomized, double-blind, placebo-controlled, parallel-group clinical study aims to evaluate the effect of a dietary supplement on LDL-cholesterol levels in healthy adults with suboptimal LDL-C values. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Dyslipidaemia
- What is being tested?
- NUT2
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteItaly
- Study dates
- 21 Feb 2020to 21 Dec 2020
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The subjects will have to meet all the following inclusion criteria:
- Subjects agree to participate in the study and having dated and signed the informed consent form.
- Subjects who have the capability to communicate, to make themselves understood, and to comply with the study's requirements.
- Male or female aged ≥ 18 years and ≤ 70 years old.
- LDL-Cholesterol plasma levels >115 mg/dL and < 190 mg/dL.
- TG<400 mg/dL.
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- Subjects who, according to the SCORE charts, have a low or moderate cardiovascular risk (defined as a total cardiovascular risk < 5%) and for whom, according to ESC/EAS guidelines 2012, the intervention strategy does not require a pharmacological lipid-lowering intervention.
- Patient covered by the Social Security scheme.
- Pregnancy test.
Who cannot join
- Subjects already affected by cardiovascular diseases (secondary prevention) or with estimated 10 years cardiovascular disease risk> 5%;
- Obesity (BMI>30 kg/m2) or diabetes mellitus;
- Assumption of lipid lowering drugs or food supplements, or drugs potentially affecting the lipid metabolism;
- Antihypertensive treatment not stabilized since at least 3 months;
- Anticoagulants therapy
- Uncontrolled hypertension (systolic blood pressure> 190 mmHg or diastolic arterial pressure> 100 mmHg);
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- Known current thyroid, gastrointestinal or hepatobiliary diseases;
- Any medical or surgical condition that would limit the patient adhesion to the study protocol;
- Abuse of alcohol or drugs (current or previous);
- History of malignant neoplasia in the 5 years prior to enrolment in the study;
- History or clinical evidence of inflammatory disease such as severe arthritis, systemic lupus erythematosus or chronic inflammatory diseases or current therapy with immunosuppressive agents or long-term glucocorticoids;
- History or clinical evidence of any significant concomitant disease that could compromise the safety of the subject or the possibility of completing the study;
- Known previous intolerance to one component of the tested nutraceuticals
- Women in fertile age not using consolidated contraceptive methods
- Pregnancy and Breastfeeding.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Effect of a Food Supplementation With a Combined Food Supplement in Healthy Subjects With Suboptimal LDL-C Levels: a Two-arm Double-blind, Placebo- Controlled, Randomized, Clinical Trial.
This randomized, double-blind, placebo-controlled, parallel-group clinical study aims to evaluate the effect of a dietary supplement on LDL-cholesterol levels in healthy adults with suboptimal LDL-C values. Eligible participants will follow standard dietary recommendations based on the Mediterranean diet, according to the European Atherosclerosis Society guidelines. Subjects will be randomized to receive either the dietary supplement (1 tablet/day) or placebo (1 tablet/day), both in combination with dietary recommendations, over a treatment period of 12 weeks.
The primary objective is to compare the effect of the tested food supplement versus placebo on LDL-cholesterol after 12 weeks of treatment. Secondary objectives include evaluating changes in LDL-cholesterol at 6 weeks, other lipid fractions, homocysteine, glucose and insulin levels, hsCRP, anthropometric parameters, as well as tolerability and acceptability of the supplement. Safety will be assessed through the collection of adverse events.
Study participation lasts approximately 16 weeks, including screening, diet stabilization run-in, treatment, and follow-up assessments. Outcome measures will be collected at baseline, after 6 weeks, and after 12 weeks of treatment.
- Conditions
- Dyslipidaemia
- Being tested
- NUT2, Placebo
- Medical subject headings
- Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NUT2Dietary supplement
Food supplement formulated with natural extracts
PlaceboOther
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Novel food supplement and mediterranean diet | Experimental | Not described Receives: Dietary Supplement: NUT2 |
| Placebo and mediterranean diet | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect on LDL Cholesterol
Measured: 12 weeks
Secondary outcomes (21)
Effect on LDL Cholesterol
Measured: 6 weeks
Effect on Total Cholesterol
Measured: 12 weeks
Effect on Total Cholesterol
Measured: 6 weeks
Effect on HDL Cholesterol
Measured: 12 weeks
Effect on HDL Cholesterol
Measured: 6 weeks
Effect on Tryglicerides
Measured: 12 weeks
Effect on Tryglicerides
Measured: 6 weeks
Effect on Homocysteine
Measured: 12 weeks
Effect on Homocysteine
Measured: 6 weeks
Effect on Glycaemia
Measured: 12 weeks
Effect on Glycaemia
Measured: 6 weeks
Effect on Insulin
Measured: 12 weeks
Effect on Insulin
Measured: 6 weeks
Effect on Body Weight
Measured: 12 weeks
Effect on Body Weight
Measured: 6 weeks
Effect on Waist Circumference
Measured: 12 weeks
Effect on Waist Circumference
Measured: 6 weeks
Effect on Blood Pressure
Measured: 12 weeks
Effect on Blood Pressure
Measured: 6 weeks
Effect on hsCRP
Measured: 12 weeks
Effect on hsCRP
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2026
- Study start21 Feb 2020
- Primary completion21 Dec 2020
- Study completion21 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DyslipidaemiaStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cooper Consumer Health
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Meda Pharma S.p.A.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07492264
- Sponsor's protocol ID
- NUT2-2019
- Status last verified
- Mar 2026
- First submitted
- 10 Mar 2026
- Last updated
- 23 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
De Leo V, Citterio C, Smith AB, Fawkes N. Effects of a Multi-Component Nutraceutical (NUT2) on the Lipid Profile in Adults with Low-to-Moderate Cardiovascular Risk: A Randomized Placebo-Controlled Trial. Nutrients. 2026 Aug 12;18(16):2632. doi: 10.3390/nu18162632.
PubMed 42654212
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of a Food Supplementation With a Combined Food Supplement in Healthy Subjects With Suboptimal LDL-C Levels: a Two-arm Double-blind, Placebo- Controlled, Randomized, Clinical Trial.
- ClinicalTrials.gov ID
- NCT07492264
- Acronym / sponsor ID
- NUT2-2019
- Conditions
- Dyslipidaemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Cooper Consumer HealthIndustry (pharma, biotech, devices)
- Collaborators
- Meda Pharma S.p.A.
- Study start
- 21 Feb 2020 (actual)
- Primary completion
- 21 Dec 2020 (actual)
- Study completion
- 21 Dec 2020 (actual)
- First posted
- 25 Mar 2026 (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.
This randomized, double-blind, placebo-controlled, parallel-group clinical study aims to evaluate the effect of a dietary supplement on LDL-cholesterol levels in healthy adults with suboptimal LDL-C values. Eligible participants will follow standard dietary recommendations based on the Mediterranean diet, according to the European Atherosclerosis Society guidelines. Subjects will be randomized to receive either the dietary supplement (1 tablet/day) or placebo (1 tablet/day), both in combination with dietary recommendations, over a treatment period of 12 weeks.
The primary objective is to compare the effect of the tested food supplement versus placebo on LDL-cholesterol after 12 weeks of treatment. Secondary objectives include evaluating changes in LDL-cholesterol at 6 weeks, other lipid fractions, homocysteine, glucose and insulin levels, hsCRP, anthropometric parameters, as well as tolerability and acceptability of the supplement. Safety will be assessed through the collection of adverse events.
Study participation lasts approximately 16 weeks, including screening, diet stabilization run-in, treatment, and follow-up assessments. Outcome measures will be collected at baseline, after 6 weeks, and after 12 weeks of treatment.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Novel food supplement and mediterranean diet | Experimental | Dietary Supplement: NUT2 |
| Placebo and mediterranean diet | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Subjects agree to participate in the study and having dated and signed the informed consent form.
- Subjects who have the capability to communicate, to make themselves understood, and to comply with the study's requirements.
- Male or female aged ≥ 18 years and ≤ 70 years old.
- LDL-Cholesterol plasma levels >115 mg/dL and < 190 mg/dL.
- TG<400 mg/dL.
Key exclusion criteria (15 listed)
- Subjects already affected by cardiovascular diseases (secondary prevention) or with estimated 10 years cardiovascular disease risk> 5%;
- Obesity (BMI>30 kg/m2) or diabetes mellitus;
- Assumption of lipid lowering drugs or food supplements, or drugs potentially affecting the lipid metabolism;
- Antihypertensive treatment not stabilized since at least 3 months;
- Anticoagulants therapy
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 |
|---|---|---|
| NUT2Food supplement formulated with natural extracts | Dietary supplement | Novel food supplement and mediterranean diet |
| PlaceboPlacebo | Other | Placebo and mediterranean diet |
Primary outcome
Effect on LDL Cholesterol
Time frame: 12 weeks
21 secondary outcomes
Effect on LDL Cholesterol
Time frame: 6 weeks
Effect on Total Cholesterol
Time frame: 12 weeks
Effect on Total Cholesterol
Time frame: 6 weeks
Effect on HDL Cholesterol
Time frame: 12 weeks
Effect on HDL Cholesterol
Time frame: 6 weeks
Effect on Tryglicerides
Time frame: 12 weeks
Effect on Tryglicerides
Time frame: 6 weeks
Effect on Homocysteine
Time frame: 12 weeks
Effect on Homocysteine
Time frame: 6 weeks
Effect on Glycaemia
Time frame: 12 weeks
Effect on Glycaemia
Time frame: 6 weeks
Effect on Insulin
Time frame: 12 weeks
Effect on Insulin
Time frame: 6 weeks
Effect on Body Weight
Time frame: 12 weeks
Effect on Body Weight
Time frame: 6 weeks
Effect on Waist Circumference
Time frame: 12 weeks
Effect on Waist Circumference
Time frame: 6 weeks
Effect on Blood Pressure
Time frame: 12 weeks
Effect on Blood Pressure
Time frame: 6 weeks
Effect on hsCRP
Time frame: 12 weeks
Effect on hsCRP
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2026.
- Derived from this study: PubMed 42654212De Leo V, Citterio C, Smith AB, Fawkes N. Effects of a Multi-Component Nutraceutical (NUT2) on the Lipid Profile in Adults with Low-to-Moderate Cardiovascular Risk: A Randomized Placebo-Controlled Trial. Nutrients. 2026 Aug 12;18(16):2632. doi: 10.3390/nu18162632.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NUT2 in people with Dyslipidaemia, run by Cooper Consumer Health at 1 site in Italy.
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 9 inclusion and 15 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: finished, as of the sponsor's last update on 23 Oct 2026. 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 Italy. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect on LDL Cholesterol (time frame: 12 weeks). 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 NCT07492264, which also lists 1 linked publication.
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 Oct 2026.