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

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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Conditions Dyslipidemias
Hypercholesterolemia
Interventions Dietary Supplement: Phytosterol
Dietary Supplement: Placebo
Enrollment 52
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Phytosterols Placebo
Hide Arm/Group Description
  1. Milk powder: subjects will 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.
  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).

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.

  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.
  2. Drinking yoghurt: the daily volume consumed will be 90 ml/day without phytosterols.

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.

Period Title: Overall Study
Started 24 28
Completed 24 24
Not Completed 0 4
Reason Not Completed
Adverse Event             0             4
Arm/Group Title Phytosterols Placebo Total
Hide Arm/Group Description
  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.
  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.
Total of all reporting groups
Overall Number of Baseline Participants 24 28 52
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 24 participants 28 participants 52 participants
53.2  (6.1) 53.2  (6.6) 53.2  (6.32)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants 28 participants 52 participants
Female
17
  70.8%
14
  50.0%
31
  59.6%
Male
7
  29.2%
14
  50.0%
21
  40.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Chile Number Analyzed 24 participants 28 participants 52 participants
24 28 52
Body mass index  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 24 participants 28 participants 52 participants
27.9  (3.5) 27.9  (3.2) 27.9  (3.3)
Total Cholesterol  
Mean (Standard Deviation)
Unit of measure:  Mg/dl
Number Analyzed 24 participants 28 participants 52 participants
231.9  (22.9) 226.4  (19.3) 228.9  (21)
LDL-cholesterol  
Mean (Standard Deviation)
Unit of measure:  Mg/dl
Number Analyzed 24 participants 28 participants 52 participants
149.5  (18.6) 146.3  (15.6) 147.7  (16.9)
1.Primary Outcome
Title Serum LDL Cholesterol
Hide Description [Not Specified]
Time Frame 1 month
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Phytosterols Placebo
Hide Arm/Group Description:
  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.
  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.
Overall Number of Participants Analyzed 24 24
Mean (Standard Deviation)
Unit of Measure: mg/dl
122.2  (34.6) 113.5  (33.8)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Phytosterols Placebo
Hide Arm/Group Description
  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.
  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.
All-Cause Mortality
Phytosterols Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Phytosterols Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/24 (0.00%)      0/28 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 3%
Phytosterols Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/24 (0.00%)      2/28 (7.14%)    
Gastrointestinal disorders     
Abdominal pain and bloating   0/24 (0.00%)  0 1/28 (3.57%)  1
Skin and subcutaneous tissue disorders     
urticarial rash   0/24 (0.00%)  0 1/28 (3.57%)  1
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Prior authorization of the text by the Sponsor
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Sandra Hirsch
Organization: Nutrition and Food Technology Institute, University of Chile
Phone: +56229781495
EMail: shirsch@inta.uchile.cl
Layout table for additonal information
Responsible Party: Natalia Jara, University of Chile
ClinicalTrials.gov Identifier: NCT02644109    
Other Study ID Numbers: Acticol - 001
First Submitted: December 21, 2015
First Posted: December 31, 2015
Results First Submitted: June 21, 2016
Results First Posted: August 2, 2016
Last Update Posted: September 12, 2016