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| Name | Class |
|---|---|
| Pontificia Universidad Catolica de Chile | OTHER |
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Hypercholesterolemia is an important risk factor for cardiovascular disease, asociated primarily with high plasma levels of LDL lipoprotein, which in turn depend on the endogenous hepatic synthesis of cholesterol and its absorption at intestinal level. It has been demonstrated that there reducing plasma LDL is beneficial, mainly with the use of statins, which are the first treatment option for a moderate hypercholesterolemia.
Phytosterols reduce the intestinal absorption of cholesterol by reducing its incorporation into lipid micelles. Consequently, phytosterols have become a relevant alternative treatment against low hypercholesterolemia. The target population are 40 to 65 years old individuals with low hypercholesterolemia.
Different protocols have demonstrated that phytosterol intake fluctuates between 1000 to 2000 mg per day decreasing LDL by around 10%, independently of levels of blood triglycerides and HDL (high density lipoproteins) concentrations. In fact, the National Cholesterol Education Program and the American Heart Association recommend the addition of 2 g/day of phytosterols to daily diet of adults. This is also recommended by the FDA (Food and Drug administration).
Phytosterols delivery has been proven effective when administrated in lipid matrixes such as margarines and dressings and low-fat such as skimmed milk and yogurt, proving to have an hypolipidemic effect. The investigational products consist of powder milk and a drinking yoghurt with the addition of esterified phytosterols, with a total daily intake of 1.95 g/day (1.17 g/day of free equivalent).
Primary objective: To evaluate the impact in Chilean population of phytosterols incorporated into dairy products in reduction of LDL cholesterol.
Secondary objectives:
The trial has been designed to evaluate the effect of phytosterols incorporated to low fat dairy products in Chile, through the consumption of one glass of milk powder and 90 mL of drinking yoghurt, which results in a daily consumption of 1.95 g/day of esterified phytosterols. This amount falls within demonstrated effective doses reported in literature.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phytosterols | Experimental |
|
|
| Placebo | Placebo Comparator |
|
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Phytosterol | Dietary Supplement | Day 1: Anthropometry, laboratory test, dietary intake (24 hour recall and food frequency questionnaire) and presence of symptoms and side effects will be determined, a logbook will be provided to record product consumption, symptoms, medications and side effects. Then will be randomly assigned to one of the groups. Days 7 & 21: 24 hour recall, review of symptoms, side effects and adherence as registered in the logbook. Days 15 & 30: Anthropometry, vital signs, venous blood sample, review of symptoms, side effects and adherence to intervention as registered on logbook, dietary intake (24-hour recall), delivery of monetary compensation proportional to the study days will be given before being discharged. |
| Measure | Description | Time Frame |
|---|---|---|
| Serum LDL Cholesterol | 1 month |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sandra Hirsch, MD | University of Chile | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Nutrition, Diabetes and Metabolism. Pontificia Universidad Catolica de Chile | Santiago | Santiago Metropolitan | Chile | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24474185 | Background | Stone NJ, Robinson JG, Lichtenstein AH, Goff DC Jr, Lloyd-Jones DM, Smith SC Jr, Blum C, Schwartz JS; 2013 ACC/AHA Cholesterol Guideline Panel. Treatment of blood cholesterol to reduce atherosclerotic cardiovascular disease risk in adults: synopsis of the 2013 American College of Cardiology/American Heart Association cholesterol guideline. Ann Intern Med. 2014 Mar 4;160(5):339-43. doi: 10.7326/M14-0126. | |
| 16404415 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Phytosterols |
Day 1: Anthropometry, laboratory test, dietary intake (24 hour recall and food frequency questionnaire), presence of symptoms and side effects will be determined. Then will be randomly assigned to one of the groups. Days 7 & 21: 24 hour recall, review of symptoms, side effects and adherence as registered in the logbook. Days 15 & 30: Anthropometry, vital signs, venous blood sample, review of symptoms, side effects and adherence to intervention as registered on logbook, dietary intake (24-hour recall), delivery of monetary compensation proportional to the study days will be given before being discharged. |
| FG001 | Placebo |
Day 1: Anthropometry, laboratory test, dietary intake (24 hour recall and food frequency questionnaire) and presence of symptoms and side effects will be determined, a logbook will be provided to record product consumption, symptoms, medications and side effects. Then will be randomly assigned to one of the groups. Days 7 & 21: 24 hour recall, review of symptoms, side effects and adherence as registered in the logbook. Days 15 & 30: Anthropometry, vital signs, venous blood sample, review of symptoms, side effects and adherence to intervention as registered on logbook, dietary intake (24-hour recall), delivery of monetary compensation proportional to the study days will be given before being discharged. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Phytosterols |
|
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Serum LDL Cholesterol | Posted | Mean | Standard Deviation | mg/dl | 1 month |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Phytosterols |
|
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain and bloating | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Sandra Hirsch | Nutrition and Food Technology Institute, University of Chile | +56229781495 | shirsch@inta.uchile.cl |
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| ID | Term |
|---|---|
| D050171 | Dyslipidemias |
| D006937 | Hypercholesterolemia |
| ID | Term |
|---|---|
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D006949 | Hyperlipidemias |
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| ID | Term |
|---|---|
| D010840 | Phytosterols |
| ID | Term |
|---|---|
| D013261 | Sterols |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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|
| Placebo | Dietary Supplement | Day 1: Anthropometry, laboratory test, dietary intake (24 hour recall and food frequency questionnaire) and presence of symptoms and side effects will be determined, a logbook will be provided to record product consumption, symptoms, medications and side effects. Then will be randomly assigned to one of the groups. Days 7 & 21: 24 hour recall, review of symptoms, side effects and adherence as registered in the logbook. Days 15 & 30: Anthropometry, vital signs, venous blood sample, review of symptoms, side effects and adherence to intervention as registered on logbook, dietary intake (24-hour recall), delivery of monetary compensation proportional to the study days will be given before being discharged. |
|
| Instituto de Nutricion y Tecnologia de los Alimentos, Universidad de Chile |
| Santiago |
| Santiago Metropolitan |
| Chile |
| Result |
| Korpela R, Tuomilehto J, Hogstrom P, Seppo L, Piironen V, Salo-Vaananen P, Toivo J, Lamberg-Allardt C, Karkkainen M, Outila T, Sundvall J, Vilkkila S, Tikkanen MJ. Safety aspects and cholesterol-lowering efficacy of low fat dairy products containing plant sterols. Eur J Clin Nutr. 2006 May;60(5):633-42. doi: 10.1038/sj.ejcn.1602362. |
| 18762410 | Result | Mannarino E, Pirro M, Cortese C, Lupattelli G, Siepi D, Mezzetti A, Bertolini S, Parillo M, Fellin R, Pujia A, Averna M, Nicolle C, Notarbartolo A. Effects of a phytosterol-enriched dairy product on lipids, sterols and 8-isoprostane in hypercholesterolemic patients: a multicenter Italian study. Nutr Metab Cardiovasc Dis. 2009 Feb;19(2):84-90. doi: 10.1016/j.numecd.2008.03.012. Epub 2008 Aug 31. |
| 16923260 | Result | Ortega RM, Palencia A, Lopez-Sobaler AM. Improvement of cholesterol levels and reduction of cardiovascular risk via the consumption of phytosterols. Br J Nutr. 2006 Aug;96 Suppl 1:S89-93. doi: 10.1079/bjn20061708. |
| 11781675 | Result | Nestel P, Cehun M, Pomeroy S, Abbey M, Weldon G. Cholesterol-lowering effects of plant sterol esters and non-esterified stanols in margarine, butter and low-fat foods. Eur J Clin Nutr. 2001 Dec;55(12):1084-90. doi: 10.1038/sj.ejcn.1601264. |
| 7566021 | Result | Miettinen TA, Puska P, Gylling H, Vanhanen H, Vartiainen E. Reduction of serum cholesterol with sitostanol-ester margarine in a mildly hypercholesterolemic population. N Engl J Med. 1995 Nov 16;333(20):1308-12. doi: 10.1056/NEJM199511163332002. |
| BG001 | Placebo |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Body mass index | Mean | Standard Deviation | kg/m^2 |
|
| Total Cholesterol | Mean | Standard Deviation | mg/dl |
|
| LDL-cholesterol | Mean | Standard Deviation | mg/dl |
|
| Placebo |
|
|
|
| 0 |
| 24 |
| 0 |
| 24 |
| EG001 | Placebo |
| 0 | 28 | 2 | 28 |
| urticarial rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
Prior authorization of the text by the Sponsor
| D011083 |
| Polycyclic Compounds |
| D008563 | Membrane Lipids |
| D008055 | Lipids |
| D064209 | Phytochemicals |
| D001685 | Biological Factors |