Propolis on human health: their role on oxidative stress and lipid metabolism a randomized clinical trial

• Register: TCTR
• Last refreshed on: 1 April 2024
• Main ID: TCTR20160114001
• Date of registration: 14/01/2016
• Prospective Registration: No
• Primary sponsor: Fondos para la Innovación de la Competitividad (FIC) Maule Nº BIP.30.136.439-0
• Public title: Propolis on human health: their role on oxidative stress and lipid metabolism a randomized clinical trial
• Scientific title: “Mejoramiento de la competitividad del sector apícola a partir de la diversificación de productos y su evaluación como aporte a la salud del Maule.”
• Date of first enrolment: 19/03/2014
• Target sample size: 65
• Recruitment status: Completed
• URL: https://www.thaiclinicaltrials.org/show/TCTR20160114001
• Study type: Interventional
• Study design: Randomized
• Phase: Phase 0

Countries of recruitment

Chile

Contacts

• Name: Elba Leiva
• Affiliation: Universidad de Talca

• Name: Veronica Mujica
• Affiliation: Universidad Catolica del Maule, Hospital Regional de Talca

Key inclusion & exclusion criteria

Inclusion criteria: The inclusion criteria were: (1) age > 18 and < 69 years, (2) to have at least one of the following altered parameters: fast glycaemia, lipids profile, blood pressure, and/or over weight. To have some metabolism disorders like: diabetes mellitus, and cardiovascular disease.
Exclusion criteria: The exclusion criteria were: (i) history of significant alcohol consumption; (ii) background of any known important acute or chronic pathological conditions such liver and/or renal failure, immunological disorders, VIH, cancer, among others); (iii) unlikely to cooperate with the study regime. During the study 8 subjects were voluntary retired and 3 additional were excluded by have the insulinaemia over normal range (> 100 µU /mL).

Age minimum: 0 Years
Age maximum: 0 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Propolis
antioxidant
lipids profile
HDL-c

Subject with metabolic disorders such cardiovascular disease, diabetes, obesity. Subjects with some of the next laboratory altered parameters: fast glycaemia. lipids profile, blood pressure, a/or ove
Propolis
antioxidant
lipids profile
HDL-c

Intervention(s)

. The eligible subjects were randomized in two groups. One consumed propolis (n=35) and the other one (n=32) consume a placebo with same flavors and appearance than propolis (a mixture of peppermint and fernet synthetic flavors). The propolis and placebo were administered orally twice a day in the same dose and formulation (15 drops each time) for 90 days. All subjects were evaluated at 0 (basal), 45 and 90 days, also they were controlled by phone interview, focus group and personal interview along the study. All the analysis was made at day zero and ninety.

Placebo Comparator Dietary Supplement

Propolis in human health

Primary Outcome(s)

Propolis diversity use in human health 6 months case-control, randomized, double blind, placebo controlled

Secondary Outcome(s)

Propolis in human health 6 months case-control, randomized, double blind, placebo controlled

Source(s) of Monetary Support

Fondos para la Innovación de la Competitividad (FIC) Maule Nº BIP.30.136.439-0 and Rotterdam Labo

Secondary Sponsor(s)

Fondos para la Innovación de la Competitividad (FIC) Maule Nº BIP.30.136.439-0 and Rotterdam Labo

Ethics review

Status: Request not yet submitted
Approval date:
Contact:

Results

• Date Completed: 23/05/2014