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Effect On Serum Cholesterol Of Dairy Products With Addition Of Esterified Phytosterols (ACTICOL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02644109
Recruitment Status : Completed
First Posted : December 31, 2015
Results First Posted : August 2, 2016
Last Update Posted : September 12, 2016
Sponsor:
Collaborator:
Pontificia Universidad Catolica de Chile
Information provided by (Responsible Party):
Natalia Jara, University of Chile

Tracking Information
First Submitted Date  ICMJE December 21, 2015
First Posted Date  ICMJE December 31, 2015
Results First Submitted Date  ICMJE June 21, 2016
Results First Posted Date  ICMJE August 2, 2016
Last Update Posted Date September 12, 2016
Study Start Date  ICMJE October 2015
Actual Primary Completion Date March 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 21, 2016)
Serum LDL Cholesterol [ Time Frame: 1 month ]
Original Primary Outcome Measures  ICMJE
 (submitted: December 28, 2015)
Serum LDL cholesterol [ Time Frame: 1 month ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect On Serum Cholesterol Of Dairy Products With Addition Of Esterified Phytosterols
Official Title  ICMJE Effect On Serum Cholesterol Of Dairy Products With Addition Of Esterified Phytosterols In Chilean Subjects With Hypercholesterolemia
Brief Summary

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.

Detailed Description

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:

  1. To evaluate potential changes in blood cholesterol concentration according to nutritional state and age.
  2. To determine the appearance of symptoms and/or effects during the intervention period.

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Dyslipidemias
  • Hypercholesterolemia
Intervention  ICMJE
  • Dietary Supplement: Phytosterol

    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.

    Other Name: ACTICOL
  • Dietary Supplement: 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.

Study Arms  ICMJE
  • Experimental: Phytosterols
    1. Milk powder: subjects will be instructed to consume 22 g/day of the product, with 0.65 g of esterified phytosterols (0.39 g of free equivalent sterols). The product will be reconstituted with 200 ml of water at time of consumption, preferably at breakfast or tea time. The total amount of product will be provided at the beginning of the study (day 1), together with instructions, material for preparation, and storage.
    2. Drinking yoghurt: the daily volume consumed will be 90 ml/day with 1.3 grs of esterified phytosterols (0.78 g of free equivalent phytosterols). Subjects will be instructed to consume this beverage with main meal (not later than 15 min after it. The product should be kept refrigerated. Products will be distributed to subjects on a weekly basis.
    Intervention: Dietary Supplement: Phytosterol
  • Placebo Comparator: Placebo
    1. Milk powder: subjects will be instructed to consume 22 g/day of the product, without phytosterols. The product will be reconstituted with 200 ml of water at time of consumption, preferably at breakfast or tea time. The total amount of product will be provided at the beginning of the study (day 1), together with instructions, material for preparation, and storage.
    2. Drinking yoghurt: the daily volume consumed will be 90 ml/day without phytosterols. Subjects will be instructed to consume this beverage with main meal (not later than 15 min after it. The product should be kept refrigerated. Products will be distributed to subjects on a weekly basis.
    Intervention: Dietary Supplement: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 21, 2016)
52
Original Estimated Enrollment  ICMJE
 (submitted: December 28, 2015)
86
Actual Study Completion Date  ICMJE May 2016
Actual Primary Completion Date March 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Individuals between 40 to 65 y old.
  2. Males and females.
  3. Body mass index between 20 to 35 kg/m2
  4. Mild hypercholesterolemia (LDL between 130 to 190 mg/dl) without requirement of immediate pharmacological treatment.
  5. Without symptoms of atherosclerotic vascular disease.
  6. Regular consumption of dairy foods (at least once a day).
  7. Sedentary lifestyle defined as less than 20 min, three times per week of moderate to intense physical activity)

Exclusion Criteria:

  1. Individuals with sitosterolemia.
  2. Use of hypolipidemic drugs within the past 6 weeks before initiated the study.
  3. Presence of type 1 or 2 diabetes; nephrotic syndrome or chronic kidney disease at stage III (estimated glomerular filtration rate<60 ml/min) or higher; gastrointestinal, liver, hepatobiliary, endocrine diseases or any condition potentially effecting lipid metabolism.
  4. History of heart failure, unstable angina, cerebrovascular accident, heart failure, uncontrolled arrhythmias, high blood pressure (systolic>160 mm/Hg or diastolic>100 mm/Hg), cardiac surgery or other vascularization procedure.
  5. Blood triglycerides higher than 400 mg/dl.
  6. History of cancer disease over the last 5 years.
  7. Pregnant and lactating women.
  8. Lactose intolerant individuals or presence of related symptoms
  9. Individuals with cow´s milk protein allergy.
  10. Vegetarians
  11. Regular use of drugs for obesity treatment, or affecting lipid metabolism.
  12. Regular use of nutritional supplements.
  13. Smokers having more than 5 units per day.
  14. Individuals drinking more than 3 standard units per day of alcoholic beverages (>3 glasses of wine, 2 beers o 1 strong alcohol).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Chile
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02644109
Other Study ID Numbers  ICMJE Acticol - 001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Natalia Jara, University of Chile
Study Sponsor  ICMJE University of Chile
Collaborators  ICMJE Pontificia Universidad Catolica de Chile
Investigators  ICMJE
Study Director: Sandra Hirsch, MD University of Chile
PRS Account University of Chile
Verification Date August 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP