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

IBSA

Status: Enrolling

Conditions: Supplementation; Hypercholesterolemia and Hyperlipidemia

Treatments: Dietary Supplement: Test Product A; Dietary Supplement: Placebo; Dietary Supplement: Test Product B

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06810466

COLE_TRIAL_2023 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 99 estimated patients

Sex: All

Ages: 18 to 69 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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99 participants in 3 patient groups, including a placebo group

Test Product A

Experimental group

Description:

Innovative formulation of dietary supplement

Treatment:

Dietary Supplement: Test Product A

Test Product B

Active Comparator group

Description:

Classic formulation of dietary supplement

Treatment:

Dietary Supplement: Test Product B

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Dietary Supplement: Placebo