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

NCT06574711 | Completed

• 1 other identifier: 20415
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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

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

Outcome Measures

Primary Outcomes (7)

• 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

Study Arms (3)

Control yogurt

PLACEBO COMPARATOR

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

Other: Control yogurt

Sacha inchi oil yogurt

EXPERIMENTAL

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

Hybrid palm oil yogurt

EXPERIMENTAL

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

Interventions

Sacha inchi oil yogurt OTHER

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

Sacha inchi oil yogurt

Hybrid palm oil yogurt OTHER

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

Hybrid palm oil yogurt

Control yogurt OTHER

Conventional full-fat yogurt

Control yogurt

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pontificia Universidad Javeriana: lead
• Universidad Nacional de Colombia: collaborator

Study Sites (1)

Pontificia Universidad Javeriana

Bogotá, 110231, Colombia

Location

MeSH Terms

Conditions

Cardiovascular Diseases; Food Preferences

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Study Officials

• Lilia Y Cortés, PhD

  Pontificia Universidad Javeriana

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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).
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: A pilot randomized; double-blind, parallel-controlled pragmatic trial was performed

Study Record Dates

• First Submitted: August 14, 2024
• First Posted: August 28, 2024
• Study Start: March 22, 2022
• Primary Completion: November 30, 2022
• Study Completion: May 7, 2024
• Last Updated: August 28, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CO (1)