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

Официальное название

A Single-blind, Parallel-group, Randomized, Placebo-controlled Clinical Trial, to Evaluate the Effects of Two Different Formulations of a Dietary Supplement on the Lipid Profile in Subjects with Mild Hypercholesterolemia

Обзор

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.

Вмешательства

• Пищевая добавка Test Product A
  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.
• Пищевая добавка Test Product B
  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.
• Пищевая добавка Placebo
  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.

Первичные конечные точки

• Low-Density Lipoprotein Cholesterol (LDL-C) Serum Concentration After Target Product A Treatment [Срок оценки: At baseline (T0) and at 8 weeks.]
• Low-Density Lipoprotein Cholesterol (LDL-C) Serum Concentration After Target Product A Treatment [Срок оценки: At baseline (T0) and at 8 weeks.]

Вторичные конечные точки (12)

• Low-Density Lipoprotein Cholesterol (LDL-C) Serum Concentration After Treatment with Target Product B [Срок оценки: At baseline (T0) and at 8 weeks.]
• Low-Density Lipoprotein Cholesterol (LDL-C) Serum Concentration After Treatment with Target Product B [Срок оценки: At baseline (T0), and at 8 weeks (T1)]
• Serum Total Cholesterol Concentration (TC) [Срок оценки: At baseline (T0), 8 weeks (T1), and 16 weeks (T2)]
• Serum Total Cholesterol Concentration (TC) [Срок оценки: At baseline (T0), 8 weeks (T1), and 16 weeks (T2)]
• Low-Density Lipoprotein Cholesterol (LDL-C) Serum Concentration [Срок оценки: At baseline (T0), 8 weeks (T1), and 16 weeks (T2)]
• Low-Density Lipoprotein Cholesterol (LDL-C) [Срок оценки: At baseline (T0), 8 weeks (T1), and 16 weeks (T2)]
• High-Density Lipoprotein Cholesterol (HDL-C) [Срок оценки: At baseline (T0), 8 weeks (T1), and 16 weeks (T2)]
• High-Density Lipoprotein Cholesterol (HDL-C) [Срок оценки: At baseline (T0), 8 weeks (T1), and 16 weeks (T2)]
• Non High-Density Lipoprotein Cholesterol (Non-HDL-C) [Срок оценки: At baseline (T0), 8 weeks (T1), and 16 weeks (T2)]
• Non High-Density Lipoprotein Cholesterol (Non-HDL-C) [Срок оценки: At baseline (T0), 8 weeks (T1), and 16 weeks (T2)]
• Triglycerides (TG) [Срок оценки: At baseline (T0), 8 weeks (T1), and 16 weeks (T2)]
• Triglycerides (TG) [Срок оценки: At baseline (T0), 8 weeks (T1), and 16 weeks (T2)]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Другое

Центры проведения

Италия · 1 центр

• S. Orsola-Malpighi University Hospital — Bologna

Идентификаторы

NCT: NCT06810466 · COLE_TRIAL_2023 · COLE_TRIAL_2023

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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