The Efficacy of a Food Supplement Consisting of the Combination of an Olive Extract and a Myrtle Extract for the Improvement of Lipid Metabolism in Subjects With Slightly Altered Cholesterolemia Values

NCT07668791 | Completed DMC

• 1 other identifier: Labomar
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

Brief Summary

Study Objective The aim of the study is to evaluate the efficacy of a dietary supplement based on a mixture of olive (Olea europaea L., fruit) and myrtle (Myrtus communis L., leaves) extracts in maintaining normal plasma cholesterol levels in subjects with mildly altered (borderline) cholesterol levels. Study Design A single-center, randomized, controlled, two-arm, double-blind, parallel-group clinical trial will be conducted, including a 15-day run-in period. The treatment period will last 3 months, during which subjects will receive either the dietary supplement or a placebo. This duration is considered adequate by EFSA to evaluate the clinical efficacy of commonly consumed food components or dietary supplements on hypercholesterolemia. Before starting the treatment period, enrolled subjects will undergo a 15-day run-in phase during which they will not receive any treatment but will be required to complete a daily food diary. Experimental Groups Group 1 (56 subjects): Participants will take one capsule per day of a dietary supplement consisting of a blend of olive (Olea europaea L., fruit) and myrtle (Myrtus communis L., leaves) extracts. Group 2 (56 subjects): Participants will receive a placebo\*. To control for variables that could bias the interpretation of results, participants will be instructed to: Follow an isocaloric diet for the entire duration of the study, as specified in the protocol, and record it in a food diary. Report all pharmacological treatments at each visit. \*Masking methods are described in the dedicated section. Each subject in both experimental groups will be monitored before, during, and after administration of the dietary supplement or placebo. Inclusion Criteria The study will include subjects of both sexes who meet the following criteria: Age between 18 and 70 years Ability to understand and sign informed consent Negative HIV test Negative pregnancy test Borderline total cholesterol levels (200-239 mg/dL, according to the National Institutes of Health definition) LDL cholesterol levels \<159 mg/dL Not taking any medications and willing to avoid medication throughout the study period Mildly altered LDL cholesterol levels (100-159 mg/dL), according to NCEP guidelines: Optimal: \<100 mg/dL Near optimal/above optimal: 100-129 mg/dL Borderline high: 130-159 mg/dL High: 160-189 mg/dL Very high: ≥190 mg/dL Exclusion Criteria Subjects will be excluded if they meet any of the following conditions: Age \<18 or \>70 years High cardiovascular risk based on eight risk factors (sex, age, diabetes, smoking status, systolic blood pressure, total cholesterol, HDL cholesterol, antihypertensive treatment) according to the Italian National Institute of Health "Progetto Cuore" parameters Ongoing pharmacological treatment for hypercholesterolemia and/or hyperglycemia, even at low doses Use of supplements for cholesterol, glycemia, or metabolic syndrome within two weeks prior to enrollment Pregnant women, suspected pregnancy, or planning pregnancy Breastfeeding women Blood donors within the three months prior to enrollment Non-self-sufficient individuals Subjects unwilling to cooperate Subjects unable to attend scheduled visits Subjects deemed unsuitable by the investigator due to other conditions requiring pharmacological treatment Subjects with HIV-related immunodeficiency Known allergies to the study product ingredients Alcohol consumption exceeding 30 g/day for men or 20 g/day for women Use of drugs of abuse Subjects currently taking medications

Conditions

Dyslipidaemias

Keywords

food supplement; dyslipidemia; prevention; olive extract; myrtle extract

Outcome Measures

Primary Outcomes (1)

• maintenance of normal LDL cholesterol levels in the blood in subjects with impaired cholesterolemia

  PRIMARY OBJECTIVE The primary objective of this clinical study is to evaluate the efficacy of supplementation with a dietary supplement consisting of a mixture of olive (Olea europaea L., fruit) and myrtle (Myrtus communis L., leaves) extracts in maintaining normal blood LDL cholesterol levels in subjects with altered cholesterol levels (total plasma cholesterol between 200 and 239 mg/dl and LDL cholesterol \< 159 mg/dl), which numerous clinical studies identify as an important cardiovascular risk factor. This criterion is indicated as the primary endpoint in clinical efficacy studies on hypercholesterolemia: both in the EMA guidelines (https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-clinical-investigation-medicinal-products-treatment-lipid-disorders-revision-3\_en.pdf) and in the European Food Safety Authority (EFSA) guidelines (https://www.efsa.europa.eu/en/efsajournal/pub/5136 ) EVALUATION METHODS: Measurement of blood LDL cholesterol concentration.

  [Time frame: run-in (15 days before the start of the study) , baseline (t0), and 90 days (t2) of treatment]

Secondary Outcomes (4)

• Beneficial effect on lipid metabolism.

  [Time frame: run-in (15 days before the start of the study) (tr - only TC and LDL cholesterol), baseline (t0), and 90 days (t2) of treatment].

• Beneficial effect on carbohydrate metabolism.

  [Time frame: baseline (t0) and 90 days (t2) of treatment].

• Body weight in terms of reduction of BMI (Body Mass Index) and waist circumference

  [Time frame: baseline (t0) and 90 days (t2) of treatment].

• Hepatic and renal toxicity.

  [Time frame: baseline (t0), 30 days (t1) of treatment, and 90 days (t2) of treatment].

Study Arms (2)

Evaluation of the efficacy of a food supplement based on olive extracts and myrtle extracts

EXPERIMENTAL

Below is the nutritional information for the COLTECH25 dietary supplement, based on Myrtle and Olive extracts in capsule form. Ingredients: Botanical blend: olive (Olea europaea L., fruit) dry extract (180 mg), myrtle (Myrtus communis L., leaves) dry extract (158 mg), maltodextrin; vegetable capsule (hydroxypropyl methylcellulose, coloring: calcium carbonate), bulking agents: calcium phosphates, cellulose; anti-caking agents: magnesium salts of fatty acids, silicon dioxide; coloring: iron oxides and hydroxides. Size: 90 capsules of 550 mg. Total content: 47.9 g Directions: Take one capsule daily, swallowed whole with a glass of water. Warnings: Keep out of reach of children under 3 years of age; Do not exceed the recommended daily dose; supplements should not be used as a substitute for a varied and balanced diet and a healthy lifestyle.

Dietary Supplement: Food supplement (T1675)

Placebo evaluation

PLACEBO COMPARATOR

The placebo consists of inert excipients and is identical in shape, weight, color, and packaging to the active treatment, ensuring blinding. Ingredients: maltodextrin, vegetable capsule (hydroxypropyl methylcellulose, coloring: calcium carbonate), bulking agents: calcium phosphates, cellulose; anti-caking agents: magnesium salts of fatty acids, silicon dioxide; coloring: iron oxides and hydroxides; Size: 90 capsules of 550 mg. Total content: 52.8 g Directions: Take one capsule daily, swallowed whole with a glass of water. Warnings: Keep out of reach of children under 3 years of age; Do not exceed the recommended daily dose; Supplements should not be used as a substitute for a varied and balanced diet and a healthy lifestyle.

Dietary Supplement: Placebo

Interventions

Food supplement (T1675) DIETARY_SUPPLEMENT

GROUP 1 (56 subjects): subjects who will have to take one capsule of the food supplement based on olive (Olea europaea L., fruit), and myrtle (Myrtus communis L., leaves).

Evaluation of the efficacy of a food supplement based on olive extracts and myrtle extracts

Placebo DIETARY_SUPPLEMENT

The placebo consists of inert excipients and is identical in shape, weight, color, and packaging to the active treatment, ensuring blinding. Ingredients: maltodextrin, vegetable capsule (hydroxypropyl methylcellulose, coloring: calcium carbonate), bulking agents: calcium phosphates, cellulose; anti-caking agents: magnesium salts of fatty acids, silicon dioxide; coloring: iron oxides and hydroxides; Size: 90 capsules of 550 mg. Total content: 52.8 g Directions: Take one capsule daily, swallowed whole with a glass of water. Warnings: Keep out of reach of children under 3 years of age; Do not exceed the recommended daily dose; Supplements should not be used as a substitute for a varied and balanced diet and a healthy lifestyle.

Placebo evaluation

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

The study will include subjects of both sexes: * aged between 18 and 70; * able to understand and sign the informed consent; * Negative HIV test * Negative pregnancy test * Borderline total cholesterol values, between 200 and 239 mg/dL (National Institute of Health definition) * LDL cholesterol values \< 159 mg/dL (https://www.humanitas-care.it/malattie/colesterolo/)\* * Who are not taking any medications and will not take any medication throughout the study period \* Mildly altered LDL cholesterol between 100 and 159 mg/dL (NCEP Guidelines): * Optimal: less than 100 mg/dL * Near optimal/above optimal: 100 to 129 mg/dL * High limit: 130 to 159 mg/dL * High: 160 to 189 mg/dL * Very high: greater than 190 mg/dL Education Guidelines National Cholesterol Education Program (NCEP) "Executive summary of the third report of the National Cholesterol Education Program (NCEP) expert panel on the diagnosis, evaluation, and treatment of hypercholesterolemia in adults (Adult Treatment Panel III)" (Revised\_2013) https://www.ncbi.nlm.nih.gov/books/NBK542294/#article-19466.r18 Subjects with the following characteristics will be excluded from the study: * Age \< 18 and \> 70 years; * subjects exposed to a high risk of cardiovascular events based on 8 risk factors (gender, age, diabetes, smoking, systolic blood pressure, total cholesterol, HDL cholesterol, and antihypertensive treatment) in accordance with the parameters of the Istituto Superiore di Sanità's Cuore project (http://www.cuore.iss.it/sopra/calc-rischio.asp), * undergoing pharmacological therapy for cholesterol and/or hyperglycemia, even at low doses, * taking supplements to control cholesterol, blood sugar, and metabolic syndrome in the two weeks prior to recruitment, * pregnant women, women who are pregnant or planning to become pregnant, * breastfeeding women, * blood donors in the three months prior to recruitment, * non-self-sufficient subjects, * subjects who show no willingness to cooperate, * subjects who have difficulty reaching the clinic reference facility within the required timeframe, * subjects deemed unsuitable by the investigating physician due to the presence of other conditions deemed incompatible with enrollment and requiring pharmacological treatments, * subjects with HIV-associated immunodeficiency, * subjects with known allergies to the ingredients of the study product, * subjects who consume alcohol in quantities greater than 30g/day for men and 20g/day for women, * subjects who use drugs of abuse. * subjects taking medications.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Labomar SPA: lead

Study Sites (1)

COMEGEN Soc. Coop. Sociale, Napoli, 80126

Naples, 80131, Italy

Location

Related Publications (8)

• Yong PH, Qing TY, Azzani M, Anbazhagan D, Ng ZX. Role of medicinal plants in ameliorating the lipid and glucose levels in diabetes: A systematic literature review. Endocr Regul. 2025 Apr 21;59(1):57-77. doi: 10.2478/enr-2025-0008. Print 2025 Jan 1.

  PMID: 40258225 BACKGROUND

• Rosa A, Melis MP, Deiana M, Atzeri A, Appendino G, Corona G, Incani A, Loru D, Dessi MA. Protective effect of the oligomeric acylphloroglucinols from Myrtus communis on cholesterol and human low density lipoprotein oxidation. Chem Phys Lipids. 2008 Sep;155(1):16-23. doi: 10.1016/j.chemphyslip.2008.04.005. Epub 2008 May 1.

  PMID: 18498764 BACKGROUND

• Razmpoosh E, Abdollahi S, Mousavirad M, Clark CCT, Soltani S. The effects of olive leaf extract on cardiovascular risk factors in the general adult population: a systematic review and meta-analysis of randomized controlled trials. Diabetol Metab Syndr. 2022 Oct 21;14(1):151. doi: 10.1186/s13098-022-00920-y.

  PMID: 36271405 BACKGROUND

• Perk J, De Backer G, Gohlke H, Graham I, Reiner Z, Verschuren M, Albus C, Benlian P, Boysen G, Cifkova R, Deaton C, Ebrahim S, Fisher M, Germano G, Hobbs R, Hoes A, Karadeniz S, Mezzani A, Prescott E, Ryden L, Scherer M, Syvanne M, Scholte op Reimer WJ, Vrints C, Wood D, Zamorano JL, Zannad F; European Association for Cardiovascular Prevention & Rehabilitation (EACPR); ESC Committee for Practice Guidelines (CPG). European Guidelines on cardiovascular disease prevention in clinical practice (version 2012). The Fifth Joint Task Force of the European Society of Cardiology and Other Societies on Cardiovascular Disease Prevention in Clinical Practice (constituted by representatives of nine societies and by invited experts). Eur Heart J. 2012 Jul;33(13):1635-701. doi: 10.1093/eurheartj/ehs092. Epub 2012 May 3. No abstract available.

  PMID: 22555213 BACKGROUND

• Martin SS, Aday AW, Allen NB, Almarzooq ZI, Anderson CAM, Arora P, Avery CL, Baker-Smith CM, Bansal N, Beaton AZ, Commodore-Mensah Y, Currie ME, Elkind MSV, Fan W, Generoso G, Gibbs BB, Heard DG, Hiremath S, Johansen MC, Kazi DS, Ko D, Leppert MH, Magnani JW, Michos ED, Mussolino ME, Parikh NI, Perman SM, Rezk-Hanna M, Roth GA, Shah NS, Springer MV, St-Onge MP, Thacker EL, Urbut SM, Van Spall HGC, Voeks JH, Whelton SP, Wong ND, Wong SS, Yaffe K, Palaniappan LP; American Heart Association Council on Epidemiology and Prevention Statistics Committee and Stroke Statistics Committee. 2025 Heart Disease and Stroke Statistics: A Report of US and Global Data From the American Heart Association. Circulation. 2025 Feb 25;151(8):e41-e660. doi: 10.1161/CIR.0000000000001303. Epub 2025 Jan 27.

  PMID: 39866113 BACKGROUND

• Lockyer S, Rowland I, Spencer JPE, Yaqoob P, Stonehouse W. Impact of phenolic-rich olive leaf extract on blood pressure, plasma lipids and inflammatory markers: a randomised controlled trial. Eur J Nutr. 2017 Jun;56(4):1421-1432. doi: 10.1007/s00394-016-1188-y. Epub 2016 Mar 7.

  PMID: 26951205 BACKGROUND

• Li W, Wang D, Lin C, Cai T, Zhao M, Liang L, Zhao X, He X, Liang X, Zheng J. A Meta-Analysis of the Incidence of Adverse Reactions of Statins in Various Diseases. Cardiovasc Ther. 2025 Jun 10;2025:6684099. doi: 10.1155/cdr/6684099. eCollection 2025.

  PMID: 40529509 BACKGROUND

• Derosa G, Maffioli P, D'Angelo A, Russo R. Effects of a nutraceutical combination of monacolin, gamma-oryzanol and gamma-aminobutyric acid on lipid profile and C-reactive protein in mice. Arch Med Sci. 2019 May;15(3):792-796. doi: 10.5114/aoms.2018.75193. Epub 2018 Apr 16.

  PMID: 31110547 BACKGROUND

Related Links

• EMA guidelines guidelines

MeSH Terms

Conditions

Dyslipidemias

Interventions

Dietary Supplements

Condition Hierarchy (Ancestors)

Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Claudio C Polistina, graduated

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A single-center, randomized, controlled, double-blind, two-arm parallel clinical study will be conducted, with a 15-day run-in period. The treatment period with the study products (dietary supplement or placebo) will last 3 months. This timeframe is considered adequate by EFSA to assess the clinical efficacy of components of commonly used foods or dietary supplements on hypercholesterolemia. Following enrollment, before starting the treatment period, subjects will undergo a 15-day run-in period during which they will receive no treatment but will be required to complete a daily food diary. The experimental groups will be as follows: GROUP 1 (56 subjects) → subjects who will take one capsule of a dietary supplement consisting of a mixture of olive (Olea europaea L., fruit) and myrtle (Myrtus communis L., leaves) extracts. GROUP 2 (56 subjects) → subjects who will take the placebo

Study Record Dates

• First Submitted: March 31, 2026
• First Posted: June 25, 2026
• Study Start: March 9, 2026
• Primary Completion: June 10, 2026
• Study Completion: June 20, 2026
• Last Updated: June 25, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)