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

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.

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

Study Overview

• Status: Completed
• Conditions: Cardiovascular Diseases; Food Preferences; Triglycerides; HDL; Low-density-lipoprotein-type; Functional Food; Apolipoproteins
• Intervention / Treatment: Other: Control yogurt; Other: Sacha inchi oil yogurt; Other: Hybrid palm oil yogurt

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 Type: Interventional
• Enrollment (Actual): 54
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Colombia
  • Bogotá, Colombia, 110231
    • Pontificia Universidad Javeriana

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Control yogurt; Participants consumed a 200 g bottle of plain Yogurt with 3.5% unreplaced fat orally, daily, for 90 days	Other: Control yogurt; Conventional full-fat yogurt
Experimental: Sacha inchi oil yogurt; Participants consumed a 200 g bottle of Yogurt with 3.5% replacement of dairy fat for Sacha inchi oil, orally, daily, for 90 days	Other: Sacha inchi oil yogurt; Sacha inchi oil was incorporated into a nonfat yogurt acting as a source of linolenic acid
Experimental: Hybrid palm oil yogurt; Participants consumed a 200 g bottle of Yogurt with 3.5% replacement of dairy fat for Hybrid Palm Oil, daily, for 90 days	Other: Hybrid palm oil yogurt; Interspecific hybrid palm oil was incorporated into a nonfat yogurt as a source of bioactive compounds

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Pontificia Universidad Javeriana
• Collaborators: Universidad Nacional de Colombia
• Investigators: Study Director: Lilia Y Cortés, PhD, Pontificia Universidad Javeriana

Study record dates

Study Major Dates

• Study Start (Actual): March 22, 2022
• Primary Completion (Actual): November 30, 2022
• Study Completion (Actual): May 7, 2024

Study Registration Dates

• First Submitted: August 14, 2024
• First Submitted That Met QC Criteria: August 24, 2024
• First Posted (Actual): August 28, 2024

Study Record Updates

• Last Update Posted (Actual): August 28, 2024
• Last Update Submitted That Met QC Criteria: August 24, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: cardiovascular risk; healthy volunteers; yogurt; lipid profile; PUFA; sacha inchi oil; interspecific hybrid palm oil
• Additional Relevant MeSH Terms: Cardiovascular Diseases
• Other Study ID Numbers: 20415

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Due to the informed consent, no individual data can be shared; however, the results will be shared in a scientific publication

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No