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Completed

NCT Number: NCT06574711

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

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

Completed

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Key information

Conditions

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

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pontificia Universidad Javeriana

Bogotá, 110231, Colombia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sacha inchi oil yogurt

Other

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

Hybrid palm oil yogurt

Other

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

Control yogurt

Other

Conventional full-fat yogurt

Primary outcomes

  1. Change in plasma levels of total cholesterol

    Time frame: Baseline, 1 month, 2 months and 3 months

    Measure in plasma (mmol/l)

  2. Change in plasma levels of LDL-cholesterol

    Time frame: Baseline, 1 month, 2 months and 3 months

    Measure in plasma (mmol/l)

  3. Change in plasma levels of HDL-cholesterol

    Time frame: Baseline, 1 month, 2 months and 3 months

    Measure in plasma (mmol/l)

  4. Change in plasma levels of triacylglycerols

    Time frame: Baseline, 1 month, 2 months and 3 months

    Measure in plasma (mmol/l)

  5. Change in plasma levels of Apolipoprotein A1 (ApoA1)

    Time frame: Baseline, 1 month, 2 months and 3 months

    Measure in plasma (g/l)

  6. Change in plasma levels of Apolipoprotein B (ApoB)

    Time frame: Baseline, 1 month, 2 months and 3 months

    Measure in plasma (g/l)

  7. ApoB/ApoA1 ratio

    Time frame: Baseline, 1 month, 2 months and 3 months

    prognostic predictor of a 10 year cardiovascular event

Sponsors and collaborators

Lead sponsor

Pontificia Universidad Javeriana

Other

Collaborators

  • Universidad Nacional de Colombia

Registry information

Official study 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.

Acronym: FYOPO

Important dates

Study start
2022
Primary completion
2022
Study completion
2024
First posted
Aug 28, 2024
Registry last updated
Aug 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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