Clinical trial NCT06574711: Functional Yogurt Consumption and Its Effects on the Lipid Profile of Healthy Subjects
Official title: Evaluation of the Effect of Consuming Yogurts Fortified With Dietary Sources of Vitamin E and Omega-3 on Classical Biomarkers of Cardiovascular Disease and Blood Levels of Vitamin E.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Diseases
Apolipoproteins
Food Preferences
Low-density-lipoprotein-type
HDL
Triglycerides
Functional Food
Keywords: PUFA
cardiovascular risk
lipid profile
healthy volunteers
yogurt
sacha inchi oil
interspecific hybrid palm oil
Lead sponsor: Pontificia Universidad Javeriana
Sponsor class: OTHER
Collaborators: name: Universidad Nacional de Colombia
First posted: 2024-08-28
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A pilot randomized; double-blind, parallel-controlled pragmatic trial was performed
Primary purpose: PREVENTION

Brief summary: The purpose of this study was to assess the effect of the daily intake of yogurts enhanced with Sacha Inchi oil and hybrid palm tree oil on human plasma lipids related to cardiovascular risk factors

Detailed description: After being recruited and signing a written informed consent about the study and potential risks, the participants were randomized and assigned in a double-blind manner to one of three intervention groups (control yogurt, sacha inchi oil yogurt, or hybrid palm tree oil yogurt; consumption 1 bottle of 200ml per day for 90 days.

Eligibility criteria: Inclusion Criteria:

* Normal total cholesterol (≤200mg/dl) levels
* Have a yogurt consumption habit of at least three times a week
* Maximum level of moderate physical activity
* Body mass index (BMI) of ≤29.9kg/m2
* Serum triacylglycerols below 400mg/dl

Exclusion Criteria:

* Presence of chronic disease (Arterial hypertension, Diabetes Mellitus, among others)
* A history of illicit drug use and/or chronic alcohol use, active smoking
* A well-established allergy to red palm olein and/or milk and its derivatives
* Consumption of nutritional supplements (antioxidants, omega 3, fiber, phytosterols)
* Pregnancy or lactation
* Having menopause
* High consumption of nuts, flaxseed, chia, and sesame seeds

Primary outcomes:
measure: Change in plasma levels of total cholesterol
timeFrame: Baseline, 1 month, 2 months and 3 months
measure: Change in plasma levels of LDL-cholesterol
timeFrame: Baseline, 1 month, 2 months and 3 months
measure: Change in plasma levels of HDL-cholesterol
timeFrame: Baseline, 1 month, 2 months and 3 months
measure: Change in plasma levels of triacylglycerols
timeFrame: Baseline, 1 month, 2 months and 3 months
measure: Change in plasma levels of Apolipoprotein A1 (ApoA1)
timeFrame: Baseline, 1 month, 2 months and 3 months
measure: Change in plasma levels of Apolipoprotein B (ApoB)
timeFrame: Baseline, 1 month, 2 months and 3 months
measure: ApoB/ApoA1 ratio
timeFrame: Baseline, 1 month, 2 months and 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Bogotá
country: Colombia
facility: Pontificia Universidad Javeriana
Study officials:
affiliation: Pontificia Universidad Javeriana
name: Lilia Y Cortés, PhD
role: STUDY_DIRECTOR
References: