Effects of a Multi-Component Nutraceutical (NUT2) on the Lipid Profile in Adults with Low-to-Moderate Cardiovascular Risk: A Randomized Placebo-Controlled Trial.
De Leo V, Citterio C, Smith A, Fawkes N • Nutrients • 2026
In adults with low-to-moderate cardiovascular risk and suboptimal LDL-C despite dietary intervention, NUT2 produced significant and clinically relevant improvements in LDL-C and total cholesterol over 12 weeks, was safe and well tolerated, and showed additional effects on homocysteine, fasting insulin, and metabolic syndrome prevalence.
Key Findings
Results
NUT2 significantly reduced LDL-C compared to placebo at 12 weeks.
LDL-C decreased by 13.2% with NUT2 and increased by 1.6% with placebo.
The baseline-corrected between-group difference was -23 mg/dL (95% CI -29 to -16; p < 0.001).
Baseline lipid values differed between groups and were accounted for using baseline-corrected change scores.
Study duration was 12 weeks with n=45 per group.
Results
NUT2 significantly reduced total cholesterol compared to placebo at 12 weeks.
The baseline-corrected between-group difference in total cholesterol was -26 mg/dL (95% CI -36 to -17; p < 0.001).
Both groups received standardized dietary advice alongside treatment.
This was a pre-specified secondary outcome.
Results
NUT2 produced significant reductions in homocysteine compared to placebo.
Significant reductions in homocysteine were observed with NUT2 as a secondary outcome.
The authors noted this 'further supports the broader biological activity of the multi-component formulation.'
Specific numerical values for the homocysteine change were not reported in the abstract.
Results
NUT2 was associated with lower fasting insulin concentrations compared to placebo.
Lower fasting insulin concentrations were observed with NUT2 as a secondary outcome.
Specific numerical values for the fasting insulin change were not reported in the abstract.
The authors noted this finding warrants further investigation in larger studies specifically designed for populations with metabolic dysfunction.
Results
Metabolic syndrome prevalence was significantly lower in the NUT2 group than placebo at Week 12.
Metabolic syndrome prevalence was 13.3% with NUT2 versus 37.8% with placebo at Week 12 (p = 0.008).
The authors described this as an 'exploratory finding' based on small participant numbers.
This finding was noted to warrant further investigation in larger, specifically designed studies.
Results
No significant between-group difference was observed for high-sensitivity C-reactive protein (hsCRP).
hsCRP was a pre-specified secondary outcome.
NUT2 did not produce a statistically significant reduction in hsCRP relative to placebo.
This null finding contrasts with the significant effects seen on LDL-C, total cholesterol, homocysteine, and fasting insulin.
Results
NUT2 was well tolerated with no serious treatment-related adverse events over 12 weeks.
No serious treatment-related adverse events were reported in either group.
The safety profile was assessed over the 12-week treatment period.
The study included 90 adults with low-to-moderate cardiovascular risk.
Methods
The study design was a randomized, double-blind, placebo-controlled, parallel-group trial in adults with low-to-moderate cardiovascular risk and elevated LDL-C.
90 adults were randomized: NUT2 (n=45) or placebo (n=45) for 12 weeks.
All participants received standardized dietary advice alongside study treatment.
The primary endpoint was change in LDL-C at Week 12.
Secondary outcomes included total cholesterol, triglycerides, fasting glucose, fasting insulin, hsCRP, homocysteine, anthropometric parameters, blood pressure, and metabolic syndrome prevalence.
Baseline characteristics were 'generally comparable,' though baseline lipid values differed between groups.
What This Means
This research suggests that a multi-ingredient supplement called NUT2, taken alongside dietary advice for 12 weeks, meaningfully lowered LDL ('bad') cholesterol and total cholesterol in adults who were at low-to-moderate heart disease risk and had not achieved optimal cholesterol levels through diet alone. Specifically, LDL cholesterol fell by about 13% in the NUT2 group while it slightly rose in the placebo group, representing a statistically significant and clinically meaningful difference between the two groups. The supplement also reduced levels of homocysteine (an amino acid linked to cardiovascular risk) and appeared to lower fasting insulin levels compared to placebo, though detailed numbers for these outcomes were not fully reported in the abstract.
The study also found that a much smaller proportion of people in the NUT2 group met the criteria for metabolic syndrome — a cluster of conditions including high blood pressure, elevated blood sugar, and abnormal cholesterol — compared to the placebo group at the end of the trial (13.3% versus 37.8%). However, the researchers themselves flagged this as an exploratory finding based on small numbers, meaning it should be interpreted cautiously. Notably, the supplement did not significantly reduce levels of a common inflammation marker (hsCRP), and the two groups had somewhat different baseline cholesterol levels, which the researchers attempted to account for statistically. No serious side effects related to the supplement were reported.
This research suggests that NUT2 may be a useful addition to dietary management for people with mildly elevated cardiovascular risk who cannot or do not wish to use prescription medications, though the study was relatively small and short-term. The authors call for larger studies, particularly in people with metabolic disorders, to confirm whether the benefits seen here — especially on insulin and metabolic syndrome — hold up in broader populations over longer periods.
De Leo V, Citterio C, Smith A, Fawkes N. (2026). 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. https://doi.org/10.3390/nu18162632