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| Name | Class |
|---|---|
| Universidad Nacional de Colombia | OTHER |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control yogurt | Placebo Comparator | Participants consumed a 200 g bottle of plain Yogurt with 3.5% unreplaced fat orally, daily, for 90 days |
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| 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 |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sacha inchi oil yogurt | Other | Sacha inchi oil was incorporated into a nonfat yogurt acting as a source of linolenic acid |
|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lilia Y Cortés, PhD | Pontificia Universidad Javeriana | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pontificia Universidad Javeriana | Bogotá | 110231 | Colombia |
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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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 27, 2021 |
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A pilot randomized; double-blind, parallel-controlled pragmatic trial was performed
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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).
| 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 |
|
| Aug 24, 2024 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 27, 2021 | Aug 24, 2024 | ICF_001.pdf |
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
| D005518 | Food Preferences |
| ID | Term |
|---|---|
| D005247 | Feeding Behavior |
| D001519 | Behavior |
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