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

NCT02644109 | Completed Phase 4 Results

• 1 other identifier: Acticol - 001
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 2

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.

Conditions

Dyslipidemias; Hypercholesterolemia

Outcome Measures

Primary Outcomes (1)

• Serum LDL Cholesterol

  1 month

Study Arms (2)

Phytosterols

EXPERIMENTAL

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.

Dietary Supplement: Phytosterol

Placebo

PLACEBO COMPARATOR

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.

Dietary Supplement: Placebo

Interventions

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.

Also known as: ACTICOL

Phytosterols

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.

Placebo

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Chile: lead
• Pontificia Universidad Catolica de Chile: collaborator

Study Sites (2)

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

Santiago, Santiago Metropolitan, Chile

Location

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

Santiago, Santiago Metropolitan, Chile

Location

Related Publications (6)

• 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.

  PMID: 24474185 BACKGROUND

• 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.

  PMID: 16404415 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.

  PMID: 18762410 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.

  PMID: 16923260 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.

  PMID: 11781675 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.

  PMID: 7566021 RESULT

MeSH Terms

Conditions

Dyslipidemias; Hypercholesterolemia

Interventions

Phytosterols

Condition Hierarchy (Ancestors)

Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Hyperlipidemias

Intervention Hierarchy (Ancestors)

Sterols; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Membrane Lipids; Lipids; Phytochemicals; Biological Factors

Results Point of Contact

• Title: Dr. Sandra Hirsch
• Organization: Nutrition and Food Technology Institute, University of Chile

shirsch@inta.uchile.cl

+56229781495

Study Officials

• Sandra Hirsch, MD

  University of Chile

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, MSc

Study Record Dates

• First Submitted: December 21, 2015
• First Posted: December 31, 2015
• Study Start: October 1, 2015
• Primary Completion: March 1, 2016
• Study Completion: May 1, 2016
• Last Updated: September 12, 2016
• Results First Posted: August 2, 2016

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will not share

Locations

CL (2)