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

NCT ID: NCT06574711

Last Updated: 2024-08-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-22

Study Completion Date

2024-05-07

Brief Summary

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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

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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.

Conditions

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Cardiovascular Diseases Apolipoproteins Food Preferences Low-density-lipoprotein-type HDL Triglycerides Functional Food

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A pilot randomized; double-blind, parallel-controlled pragmatic trial was performed
Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors
Forty-seven subjects were randomized and assigned to one of the three intervention groups supplemented daily with 200g of: Sacha Inchi Oil (SIO)-containing yogurt (Group-A), Hybrid palm oil (HPO)-containing yogurt (Group-B), and plain yogurt (Group-C).

Study Groups

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Control yogurt

Participants consumed a 200 g bottle of plain Yogurt with 3.5% unreplaced fat orally, daily, for 90 days

Group Type PLACEBO_COMPARATOR

Control yogurt

Intervention Type OTHER

Conventional full-fat yogurt

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

Group Type EXPERIMENTAL

Sacha inchi oil yogurt

Intervention Type OTHER

Sacha inchi oil was incorporated into a nonfat yogurt acting as a source of linolenic acid

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

Group Type EXPERIMENTAL

Hybrid palm oil yogurt

Intervention Type OTHER

Interspecific hybrid palm oil was incorporated into a nonfat yogurt as a source of bioactive compounds

Interventions

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Sacha inchi oil yogurt

Sacha inchi oil was incorporated into a nonfat yogurt acting as a source of linolenic acid

Intervention Type OTHER

Hybrid palm oil yogurt

Interspecific hybrid palm oil was incorporated into a nonfat yogurt as a source of bioactive compounds

Intervention Type OTHER

Control yogurt

Conventional full-fat yogurt

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Universidad Nacional de Colombia

OTHER

Sponsor Role collaborator

Pontificia Universidad Javeriana

OTHER

Sponsor Role lead

Responsible Party

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Ruby Alejandra Villamil

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Lilia Y Cortés, PhD

Role: STUDY_DIRECTOR

Pontificia Universidad Javeriana

Locations

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Pontificia Universidad Javeriana

Bogotá, , Colombia

Site Status

Countries

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Colombia

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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20415

Identifier Type: -

Identifier Source: org_study_id

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