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

Primary Purpose

Dyslipidemias, Hypercholesterolemia

Status

Completed

Phase

Phase 4

Locations

Chile

Study Type

Interventional

Intervention

Phytosterol

Placebo

About this trial

This is an interventional treatment trial for Dyslipidemias

Eligibility Criteria

40 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

Individuals with sitosterolemia.
Use of hypolipidemic drugs within the past 6 weeks before initiated the study.
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.
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.
Blood triglycerides higher than 400 mg/dl.
History of cancer disease over the last 5 years.
Pregnant and lactating women.
Lactose intolerant individuals or presence of related symptoms
Individuals with cow´s milk protein allergy.
Vegetarians
Regular use of drugs for obesity treatment, or affecting lipid metabolism.
Regular use of nutritional supplements.
Smokers having more than 5 units per day.
Individuals drinking more than 3 standard units per day of alcoholic beverages (>3 glasses of wine, 2 beers o 1 strong alcohol).

Sites / Locations

Instituto de Nutricion y Tecnologia de los Alimentos, Universidad de Chile
Department of Nutrition, Diabetes and Metabolism. Pontificia Universidad Catolica de Chile

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Phytosterols

Placebo

Arm Description

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. 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.

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. 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.

Outcomes

Primary Outcome Measures

Serum LDL Cholesterol

Secondary Outcome Measures

Full Information

NCT ID

NCT02644109

First Posted

December 21, 2015

Last Updated

August 1, 2016

Sponsor

University of Chile

Collaborators

Pontificia Universidad Catolica de Chile

1. Study Identification

Unique Protocol Identification Number

NCT02644109

Brief Title

Effect On Serum Cholesterol Of Dairy Products With Addition Of Esterified Phytosterols

Acronym

ACTICOL

Official Title

Effect On Serum Cholesterol Of Dairy Products With Addition Of Esterified Phytosterols In Chilean Subjects With Hypercholesterolemia

Study Type

Interventional

2. Study Status

Record Verification Date

August 2016

Overall Recruitment Status

Completed

Study Start Date

October 2015 (undefined)

Primary Completion Date

March 2016 (Actual)

Study Completion Date

May 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Chile

Collaborators

Pontificia Universidad Catolica de Chile

4. Oversight

Data Monitoring Committee

5. Study Description

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: To evaluate potential changes in blood cholesterol concentration according to nutritional state and age. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dyslipidemias, Hypercholesterolemia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

52 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Phytosterols

Arm Type

Experimental

Arm Description

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Intervention Type

Dietary Supplement

Intervention Name(s)

Phytosterol

Other Intervention Name(s)

ACTICOL

Intervention Description

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.

Intervention Type

Dietary Supplement

Intervention Name(s)

Placebo

Intervention Description

Primary Outcome Measure Information:

Title

Serum LDL Cholesterol

Time Frame

1 month

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Individuals between 40 to 65 y old. Males and females. Body mass index between 20 to 35 kg/m2 Mild hypercholesterolemia (LDL between 130 to 190 mg/dl) without requirement of immediate pharmacological treatment. Without symptoms of atherosclerotic vascular disease. Regular consumption of dairy foods (at least once a day). Sedentary lifestyle defined as less than 20 min, three times per week of moderate to intense physical activity) Exclusion Criteria: Individuals with sitosterolemia. Use of hypolipidemic drugs within the past 6 weeks before initiated the study. 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. 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. Blood triglycerides higher than 400 mg/dl. History of cancer disease over the last 5 years. Pregnant and lactating women. Lactose intolerant individuals or presence of related symptoms Individuals with cow´s milk protein allergy. Vegetarians Regular use of drugs for obesity treatment, or affecting lipid metabolism. Regular use of nutritional supplements. Smokers having more than 5 units per day. Individuals drinking more than 3 standard units per day of alcoholic beverages (>3 glasses of wine, 2 beers o 1 strong alcohol).

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sandra Hirsch, MD

Organizational Affiliation

University of Chile

Official's Role

Study Director

Facility Information:

Facility Name

Instituto de Nutricion y Tecnologia de los Alimentos, Universidad de Chile

City

Santiago

State/Province

Región Metropolitana de Santiago

Country

Chile

Facility Name

Department of Nutrition, Diabetes and Metabolism. Pontificia Universidad Catolica de Chile

City

Santiago

Country

Chile

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

24474185

Citation

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.

Results Reference

background

PubMed Identifier

16404415

Citation

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.

Results Reference

result

PubMed Identifier

18762410

Citation

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.

Results Reference

result

PubMed Identifier

16923260

Citation

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.

Results Reference

result

PubMed Identifier

11781675

Citation

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.

Results Reference

result

PubMed Identifier

7566021

Citation

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.

Results Reference

result

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Effect On Serum Cholesterol Of Dairy Products With Addition Of Esterified Phytosterols

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