Cardiovascular DiseasesFYOPONCT06574711
Functional Yogurt Consumption and Its Effects on the Lipid Profile of Healthy Subjects
A study testing Sacha inchi oil yogurt and Hybrid palm oil yogurt in people with Cardiovascular Diseases and Apolipoproteins, run by Pontificia Universidad Javeriana at 1 site in Colombia.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases, Apolipoproteins, Food Preferences
- What is being tested?
- Sacha inchi oil yogurt and Hybrid palm oil yogurt
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 1 siteColombia
- Study dates
- 22 Mar 2022to 7 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official 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.
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
Read the 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.
- Conditions
- Cardiovascular Diseases, Apolipoproteins, Food Preferences, Low-density-lipoprotein-type, HDL, Triglycerides
- Being tested
- Sacha inchi oil yogurt, Hybrid palm oil yogurt, Control yogurt
- Keywords
- PUFA, cardiovascular risk, lipid profile, healthy volunteers, yogurt, sacha inchi oil, interspecific hybrid palm oil
- Medical subject headings
- Cardiovascular Diseases, Food Preferences
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sacha inchi oil yogurtOther
Sacha inchi oil was incorporated into a nonfat yogurt acting as a source of linolenic acid
Hybrid palm oil yogurtOther
Interspecific hybrid palm oil was incorporated into a nonfat yogurt as a source of bioactive compounds
Control yogurtOther
Conventional full-fat yogurt
| Study group | Role | What they receive |
|---|---|---|
| Control yogurt | Placebo comparator | Participants consumed a 200 g bottle of plain Yogurt with 3.5% unreplaced fat orally, daily, for 90 days Receives: 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 Receives: 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 Receives: Other: Hybrid palm oil yogurt |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in plasma levels of total cholesterol
Measure in plasma (mmol/l)
Measured: Baseline, 1 month, 2 months and 3 months
Change in plasma levels of LDL-cholesterol
Measure in plasma (mmol/l)
Measured: Baseline, 1 month, 2 months and 3 months
Change in plasma levels of HDL-cholesterol
Measure in plasma (mmol/l)
Measured: Baseline, 1 month, 2 months and 3 months
Change in plasma levels of triacylglycerols
Measure in plasma (mmol/l)
Measured: Baseline, 1 month, 2 months and 3 months
Change in plasma levels of Apolipoprotein A1 (ApoA1)
Measure in plasma (g/l)
Measured: Baseline, 1 month, 2 months and 3 months
Change in plasma levels of Apolipoprotein B (ApoB)
Measure in plasma (g/l)
Measured: Baseline, 1 month, 2 months and 3 months
ApoB/ApoA1 ratio
prognostic predictor of a 10 year cardiovascular event
Measured: Baseline, 1 month, 2 months and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2024
- Study start22 Mar 2022
- Primary completion30 Nov 2022
- Study completion7 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A pilot randomized; double-blind, parallel-controlled pragmatic trial was performed
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pontificia Universidad Javeriana
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad Nacional de Colombia
- Responsible party
- Principal investigator, Ruby Alejandra Villamil, Pontificia Universidad Javeriana
- Investigators
- Lilia Y Cortés, PhD, Study director, Pontificia Universidad Javeriana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06574711
- Sponsor's protocol ID
- 20415
- Acronym
- FYOPO
- Status last verified
- Aug 2024
- First submitted
- 14 Aug 2024
- Last updated
- 28 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Due to the informed consent, no individual data can be shared; however, the results will be shared in a scientific publication
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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.
- ClinicalTrials.gov ID
- NCT06574711
- Acronym / sponsor ID
- FYOPO / 20415
- Conditions
- Cardiovascular Diseases, Apolipoproteins, Food Preferences, Low-density-lipoprotein-type, HDL, Triglycerides
- Keywords
- PUFA, cardiovascular risk, lipid profile, healthy volunteers, yogurt, sacha inchi oil, interspecific hybrid palm oil
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Pontificia Universidad JaverianaUniversity, hospital or other
- Collaborators
- Universidad Nacional de Colombia
- Study start
- 22 Mar 2022 (actual)
- Primary completion
- 30 Nov 2022 (actual)
- Study completion
- 7 May 2024 (actual)
- First posted
- 28 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- A pilot randomized; double-blind, parallel-controlled pragmatic trial was performed
| Arm | Type | Receives |
|---|---|---|
| Control yogurt | Placebo comparator | Other: Control yogurtParticipants consumed a 200 g bottle of plain Yogurt with 3.5% unreplaced fat orally, daily, for 90 days |
| Sacha inchi oil yogurt | Experimental | Other: Sacha inchi oil yogurtParticipants consumed a 200 g bottle of Yogurt with 3.5% replacement of dairy fat for Sacha inchi oil, orally, daily, for 90 days |
| Hybrid palm oil yogurt | Experimental | Other: Hybrid palm oil yogurtParticipants consumed a 200 g bottle of Yogurt with 3.5% replacement of dairy fat for Hybrid Palm Oil, daily, for 90 days |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sacha inchi oil yogurtSacha inchi oil was incorporated into a nonfat yogurt acting as a source of linolenic acid | Other | Sacha inchi oil yogurt |
| Hybrid palm oil yogurtInterspecific hybrid palm oil was incorporated into a nonfat yogurt as a source of bioactive compounds | Other | Hybrid palm oil yogurt |
| Control yogurtConventional full-fat yogurt | Other | Control yogurt |
Primary outcome
Change in plasma levels of total cholesterol
Time frame: Baseline, 1 month, 2 months and 3 months
Measure in plasma (mmol/l)
Change in plasma levels of LDL-cholesterol
Time frame: Baseline, 1 month, 2 months and 3 months
Measure in plasma (mmol/l)
Change in plasma levels of HDL-cholesterol
Time frame: Baseline, 1 month, 2 months and 3 months
Measure in plasma (mmol/l)
Change in plasma levels of triacylglycerols
Time frame: Baseline, 1 month, 2 months and 3 months
Measure in plasma (mmol/l)
Change in plasma levels of Apolipoprotein A1 (ApoA1)
Time frame: Baseline, 1 month, 2 months and 3 months
Measure in plasma (g/l)
Change in plasma levels of Apolipoprotein B (ApoB)
Time frame: Baseline, 1 month, 2 months and 3 months
Measure in plasma (g/l)
ApoB/ApoA1 ratio
Time frame: Baseline, 1 month, 2 months and 3 months
prognostic predictor of a 10 year cardiovascular event
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2024.
- Individual participant dataSharing planned: No. Due to the informed consent, no individual data can be shared; however, the results will be shared in a scientific publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lilia Y Cortés, PhD study director
Pontificia Universidad Javeriana
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sacha inchi oil yogurt and Hybrid palm oil yogurt in people with Cardiovascular Diseases and Apolipoproteins, run by Pontificia Universidad Javeriana at 1 site in Colombia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in plasma levels of total cholesterol (time frame: Baseline, 1 month, 2 months and 3 months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2024.