Evaluation of the Effects of Two Dietary Supplement Formulations on the Lipid Profile in Mild Hypercholesterolemia

NCT06810466 | Recruiting DMC

• 1 other identifier: COLE_TRIAL_2023
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 1

Brief Summary

A single-center, randomized, parallel-group, double-blind, placebo-controlled clinical study followed by an open-label phase to evaluate the effects of a new formulation of a supplement on lipid profile in subjects with mild hypercholesterolemia who are non-responsive to the Mediterranean diet. The study population consists of 99 subjects with mild hypercholesterolemia who are non-responsive to the Mediterranean diet. The participants will be divided into three groups: Group A: Test Product A (study product) Group B: Test Product B (comparative product) Placebo group: placebo The following visits are scheduled during the study: T-2 (day -35) - Screening visit, 5 weeks before T0 T-1 (day -28) - Enrollment visit, 4 weeks before T0 T0 (day 0) - Randomization visit, baseline T1 (day 56) - Interim visit, 8 weeks after T0 T2 (day 112) - Final visit, 16 weeks after T0 After the first 8 weeks of the study (double-blind), all three groups will continue with only Product A for an additional 8 weeks. This experimental design aims to highlight whether any differences between Test Product A and Test Product B observed during the first 8 weeks can be minimized when both arms receive the same treatment. Additionally, the effect of Product A will be observed at 8 and 16 weeks, thus providing efficacy data over a longer treatment period. This may also provide insights into the potential achievement of a plateau. Regarding the placebo group, it will be possible to distinguish the effect of the diet alone from the combined effect of the diet and supplementation with Test Product A.

Conditions

Hypercholesterolemia and Hyperlipidemia; Supplementation

Keywords

mild hypercholesterolemia; supplement; lipid profile; dietary supplement

Outcome Measures

Primary Outcomes (2)

• Low-Density Lipoprotein Cholesterol (LDL-C) Serum Concentration After Target Product A Treatment

  Evaluation of absolute value change in Low-Density Lipoprotein Cholesterol (LDL-C) serum concentration (expressed as mg/dL), at 8 weeks (T1) of dietary supplementation with Test Product A vs baseline (T0).

  At baseline (T0) and at 8 weeks.

• Low-Density Lipoprotein Cholesterol (LDL-C) Serum Concentration After Target Product A Treatment

  Evaluation of the percentage variation (%) in Low-Density Lipoprotein Cholesterol (LDL-C) serum concentration at 8 weeks (T1) of dietary supplementation with Test Product A, compared to baseline (T0).

  At baseline (T0) and at 8 weeks.

Secondary Outcomes (49)

• Low-Density Lipoprotein Cholesterol (LDL-C) Serum Concentration After Treatment with Target Product B

  At baseline (T0) and at 8 weeks.

• Low-Density Lipoprotein Cholesterol (LDL-C) Serum Concentration After Treatment with Target Product B

  At baseline (T0), and at 8 weeks (T1)

• Serum Total Cholesterol Concentration (TC)

  At baseline (T0), 8 weeks (T1), and 16 weeks (T2)

• Serum Total Cholesterol Concentration (TC)

  At baseline (T0), 8 weeks (T1), and 16 weeks (T2)

• Low-Density Lipoprotein Cholesterol (LDL-C) Serum Concentration

  At baseline (T0), 8 weeks (T1), and 16 weeks (T2)

Study Arms (3)

Test Product A

EXPERIMENTAL

Innovative formulation of dietary supplement

Dietary Supplement: Test Product A

Test Product B

ACTIVE COMPARATOR

Classic formulation of dietary supplement

Dietary Supplement: Test Product B

Placebo

PLACEBO COMPARATOR

Placebo

Dietary Supplement: Placebo

Interventions

Test Product A DIETARY_SUPPLEMENT

Innovative formulation of a dietary supplement for mild hypercholesterolemia. Test Product A will be admistered daily for 8 weeks. After the fist 8 weeks, this arm will continue with the intake of the Product Test A for other 8 weeks.

Test Product A

Test Product B DIETARY_SUPPLEMENT

Classic formulation of a dietary supplement for mild hypercholesterolemia. After the fist 8 weeks, this arm will continue with the intake of the Product Test A for other 8 weeks.

Test Product B

Placebo DIETARY_SUPPLEMENT

Placebo does not contain functional components and is indistinguishable from Product Test B. After the fist 8 weeks, this arm will continue with the intake of the Product Test A for other 8 weeks.

Placebo

Eligibility Criteria

• Age: 18 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Prevention of cardiovascular disease
• Low cardiovascular risk (\< 5%)
• Sub-optimal serum levels of LDL-C (130-136 mg/dl; 3.37-4.14 mmol/l) and/or non-HDL-C (160-190 mg/dl; 4.14-4.92 mmol/l) at T-2
• Signature of informed consent.

You may not qualify if:

• Patients with cardiovascular disease (in secondary prevention) or at risk of cardiovascular disease after 10 years (cardiovascular risk \>/= 5)
• diabetes mellitus
• Taking hypolipemiants, supplements or drugs that may involve lipid metabolism
• Hypertension treatment not stabilized for at least 3 months
• History of ongoing kidney, thyroid, gastrointestinal, muscle or liver disease
• Any medical-surgical treatment that may limit adherence to the study protocol
• Pregnant and/or breastfeeding women

Sponsors & Collaborators

• IBSA Farmaceutici Italia Srl: lead
• Informapro Srl: collaborator

Study Sites (1)

S. Orsola-Malpighi University Hospital

Bologna, Italy, 40138, Italy

RECRUITING

MeSH Terms

Conditions

Hypercholesterolemia; Hyperlipidemias

Condition Hierarchy (Ancestors)

Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Central Study Contacts

Arrigo Francesco Giuseppe Cicero, Prof.

CONTACT

+39 512142224; arrigo.cicero@unibo.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single-blind, parallel-group, randomized, placebo-controlled clinical trial, followed by an open label phase

Study Record Dates

• First Submitted: January 8, 2025
• First Posted: February 5, 2025
• Study Start: December 17, 2024
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: February 5, 2025

Record last verified: 2025-01

Locations

IT (1)