Trial Outcomes & Findings for Effect On Serum Cholesterol Of Dairy Products With Addition Of Esterified Phytosterols (NCT NCT02644109)
NCT ID: NCT02644109
Last Updated: 2016-09-12
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
52 participants
Primary outcome timeframe
1 month
Results posted on
2016-09-12
Participant Flow
Participant milestones
| Measure |
Phytosterols
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.
|
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.
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.
|
|---|---|---|
|
Overall Study
STARTED
|
24
|
28
|
|
Overall Study
COMPLETED
|
24
|
24
|
|
Overall Study
NOT COMPLETED
|
0
|
4
|
Reasons for withdrawal
| Measure |
Phytosterols
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.
|
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.
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.
|
|---|---|---|
|
Overall Study
Adverse Event
|
0
|
4
|
Baseline Characteristics
Effect On Serum Cholesterol Of Dairy Products With Addition Of Esterified Phytosterols
Baseline characteristics by cohort
| Measure |
Phytosterols
n=24 Participants
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.
|
Placebo
n=28 Participants
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
n=52 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
53.2 years
STANDARD_DEVIATION 6.1 • n=5 Participants
|
53.2 years
STANDARD_DEVIATION 6.6 • n=7 Participants
|
53.2 years
STANDARD_DEVIATION 6.32 • n=5 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Region of Enrollment
Chile
|
24 participants
n=5 Participants
|
28 participants
n=7 Participants
|
52 participants
n=5 Participants
|
|
Body mass index
|
27.9 kg/m^2
STANDARD_DEVIATION 3.5 • n=5 Participants
|
27.9 kg/m^2
STANDARD_DEVIATION 3.2 • n=7 Participants
|
27.9 kg/m^2
STANDARD_DEVIATION 3.3 • n=5 Participants
|
|
Total Cholesterol
|
231.9 mg/dl
STANDARD_DEVIATION 22.9 • n=5 Participants
|
226.4 mg/dl
STANDARD_DEVIATION 19.3 • n=7 Participants
|
228.9 mg/dl
STANDARD_DEVIATION 21 • n=5 Participants
|
|
LDL-cholesterol
|
149.5 mg/dl
STANDARD_DEVIATION 18.6 • n=5 Participants
|
146.3 mg/dl
STANDARD_DEVIATION 15.6 • n=7 Participants
|
147.7 mg/dl
STANDARD_DEVIATION 16.9 • n=5 Participants
|
PRIMARY outcome
Timeframe: 1 monthOutcome measures
| Measure |
Phytosterols
n=24 Participants
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.
|
Placebo
n=24 Participants
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.
|
|---|---|---|
|
Serum LDL Cholesterol
|
122.2 mg/dl
Standard Deviation 34.6
|
113.5 mg/dl
Standard Deviation 33.8
|
Adverse Events
Phytosterols
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Phytosterols
n=24 participants at risk
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.
|
Placebo
n=28 participants at risk
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.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain and bloating
|
0.00%
0/24
|
3.6%
1/28 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
urticarial rash
|
0.00%
0/24
|
3.6%
1/28 • Number of events 1
|
Additional Information
Dr. Sandra Hirsch
Nutrition and Food Technology Institute, University of Chile
Phone: +56229781495
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Prior authorization of the text by the Sponsor
- Publication restrictions are in place
Restriction type: OTHER