Functional Yogurt Consumption and Its Effects on the Lipid Profile of Healthy Subjects

Not Applicable

Completed

• Conditions: Low-density-lipoprotein-type; Triglycerides; Cardiovascular Diseases; Food Preferences; Apolipoproteins; HDL; Functional Food

• Registration Number: NCT06574711
• Lead Sponsor: Pontificia Universidad Javeriana

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.

Study Timeline

• Study Start: 2022-03-22
• Primary Completion: 2022-11-30
• Study Completion: 2024-05-07
• Status Verified: 2024-08
• Study First Submitted: 2024-08-14
• Study First Submitted QC: 2024-08-24
• Last Update Submitted: 2024-08-24
• Study First Posted: 2024-08-28
• Last Update Posted: 2024-08-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in plasma levels of Apolipoprotein A1 (ApoA1)	Baseline, 1 month, 2 months and 3 months	Measure in plasma (g/l)
Change in plasma levels of Apolipoprotein B (ApoB)	Baseline, 1 month, 2 months and 3 months	Measure in plasma (g/l)
Change in plasma levels of total cholesterol	Baseline, 1 month, 2 months and 3 months	Measure in plasma (mmol/l)
Change in plasma levels of LDL-cholesterol	Baseline, 1 month, 2 months and 3 months	Measure in plasma (mmol/l)
Change in plasma levels of HDL-cholesterol	Baseline, 1 month, 2 months and 3 months	Measure in plasma (mmol/l)
Change in plasma levels of triacylglycerols	Baseline, 1 month, 2 months and 3 months	Measure in plasma (mmol/l)
ApoB/ApoA1 ratio	Baseline, 1 month, 2 months and 3 months	prognostic predictor of a 10 year cardiovascular event

Trial Locations

Locations (1)

Pontificia Universidad Javeriana; 🇨🇴 Bogotá, Colombia