Trial Outcomes & Findings for The Effect of 3-Week Consumption of Soya Beverage Enriched With Plant Sterols on Serum LDL-C (NCT NCT02881658)
NCT ID: NCT02881658
Last Updated: 2018-05-03
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
201 participants
Primary outcome timeframe
From baseline to week 3
Results posted on
2018-05-03
Participant Flow
Participant milestones
| Measure |
Plant Sterols-enriched Soya Beverage Provided by Vitasoy
Daily consumption of 2g of plant sterols as provided by one pack of 250 ml of plant sterols-enriched soya beverage for consecutive 3 weeks, each pack consumed once with main meal (i.e breakfast, lunch or dinner).
Plant sterols-enriched soya beverage: the study product is a 2g plant sterols-enriched in 250ml soya beverage
|
Soya Beverage Provided by Vitasoy
Daily consumption of one pack of 250 ml of soya beverage (without plant sterols) for consecutive 3 weeks, each pack consumed once with main meal (i.e breakfast, lunch or dinner).
Soya beverage: the placebo product is a 250 ml soya beverage
|
|---|---|---|
|
Overall Study
STARTED
|
100
|
101
|
|
Overall Study
COMPLETED
|
98
|
96
|
|
Overall Study
NOT COMPLETED
|
2
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Plant Sterols-enriched Soya Beverage Provided by Vitasoy
n=100 Participants
Daily consumption of 2g of plant sterols as provided by one pack of 250 ml of plant sterols-enriched soya beverage for consecutive 3 weeks, each pack consumed once with main meal (i.e breakfast, lunch or dinner).
Plant sterols-enriched soya beverage: the study product is a 2g plant sterols-enriched in 250ml soya beverage
|
Soya Beverage Provided by Vitasoy
n=101 Participants
Daily consumption of one pack of 250 ml of soya beverage (without plant sterols) for consecutive 3 weeks, each pack consumed once with main meal (i.e breakfast, lunch or dinner).
Soya beverage: the placebo product is a 250 ml soya beverage
|
Total
n=201 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
46 years
STANDARD_DEVIATION 16.5 • n=100 Participants
|
44 years
STANDARD_DEVIATION 16.7 • n=101 Participants
|
45 years
STANDARD_DEVIATION 16.6 • n=201 Participants
|
|
Sex: Female, Male
Female
|
49 Participants
n=100 Participants
|
52 Participants
n=101 Participants
|
101 Participants
n=201 Participants
|
|
Sex: Female, Male
Male
|
51 Participants
n=100 Participants
|
49 Participants
n=101 Participants
|
100 Participants
n=201 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: From baseline to week 3Population: All 201 subjects were included in the population, but certain blood test result on LDL-C were not available, thus difference in the overall number of participants analyzed and the actual number of participants included to present the mean value.
Outcome measures
| Measure |
Plant Sterols-enriched Soya Beverage Provided by Vitasoy
n=100 Participants
Daily consumption of 2g of plant sterols as provided by one pack of 250 ml of plant sterols-enriched soya beverage for consecutive 3 weeks, each pack consumed once with main meal (i.e breakfast, lunch or dinner).
Plant sterols-enriched soya beverage: the study product is a 2g plant sterols-enriched in 250ml soya beverage
|
Soya Beverage Provided by Vitasoy
n=101 Participants
Daily consumption of one pack of 250 ml of soya beverage (without plant sterols) for consecutive 3 weeks, each pack consumed once with main meal (i.e breakfast, lunch or dinner).
Soya beverage: the placebo product is a 250 ml soya beverage
|
|---|---|---|
|
Mean of Serum Low-density Lipoprotein Cholesterol (LDL-C) Via Blood Test at Baseline and Week 3
Baseline
|
2.91 mmol/L
Standard Deviation 0.961
|
2.83 mmol/L
Standard Deviation 0.814
|
|
Mean of Serum Low-density Lipoprotein Cholesterol (LDL-C) Via Blood Test at Baseline and Week 3
Week 3
|
2.71 mmol/L
Standard Deviation 0.830
|
2.75 mmol/L
Standard Deviation 0.794
|
SECONDARY outcome
Timeframe: From baseline to week 3Outcome measures
| Measure |
Plant Sterols-enriched Soya Beverage Provided by Vitasoy
n=91 Participants
Daily consumption of 2g of plant sterols as provided by one pack of 250 ml of plant sterols-enriched soya beverage for consecutive 3 weeks, each pack consumed once with main meal (i.e breakfast, lunch or dinner).
Plant sterols-enriched soya beverage: the study product is a 2g plant sterols-enriched in 250ml soya beverage
|
Soya Beverage Provided by Vitasoy
n=88 Participants
Daily consumption of one pack of 250 ml of soya beverage (without plant sterols) for consecutive 3 weeks, each pack consumed once with main meal (i.e breakfast, lunch or dinner).
Soya beverage: the placebo product is a 250 ml soya beverage
|
|---|---|---|
|
Change of Low Density Lipoprotein Cholesterol (LDL-C) Via Blood Test at Baseline and Week 3
|
-7.69 percentage of change
Interval -15.36 to 2.19
|
-1.56 percentage of change
Interval -10.22 to 7.43
|
SECONDARY outcome
Timeframe: From baseline to week 3Outcome measures
| Measure |
Plant Sterols-enriched Soya Beverage Provided by Vitasoy
n=97 Participants
Daily consumption of 2g of plant sterols as provided by one pack of 250 ml of plant sterols-enriched soya beverage for consecutive 3 weeks, each pack consumed once with main meal (i.e breakfast, lunch or dinner).
Plant sterols-enriched soya beverage: the study product is a 2g plant sterols-enriched in 250ml soya beverage
|
Soya Beverage Provided by Vitasoy
n=96 Participants
Daily consumption of one pack of 250 ml of soya beverage (without plant sterols) for consecutive 3 weeks, each pack consumed once with main meal (i.e breakfast, lunch or dinner).
Soya beverage: the placebo product is a 250 ml soya beverage
|
|---|---|---|
|
Change of High-density Lipoprotein Cholesterol (HDL-C) Via Blood Test at Baseline and Week 3
|
0.0 percentage of change
Interval -5.56 to 7.69
|
0.0 percentage of change
Interval -6.67 to 11.11
|
SECONDARY outcome
Timeframe: From baseline to week 3Outcome measures
| Measure |
Plant Sterols-enriched Soya Beverage Provided by Vitasoy
n=97 Participants
Daily consumption of 2g of plant sterols as provided by one pack of 250 ml of plant sterols-enriched soya beverage for consecutive 3 weeks, each pack consumed once with main meal (i.e breakfast, lunch or dinner).
Plant sterols-enriched soya beverage: the study product is a 2g plant sterols-enriched in 250ml soya beverage
|
Soya Beverage Provided by Vitasoy
n=96 Participants
Daily consumption of one pack of 250 ml of soya beverage (without plant sterols) for consecutive 3 weeks, each pack consumed once with main meal (i.e breakfast, lunch or dinner).
Soya beverage: the placebo product is a 250 ml soya beverage
|
|---|---|---|
|
Change of Total Cholesterol Via Blood Test at Baseline and Week 3
|
-2.82 percentage of change
Interval -8.38 to 3.16
|
-1.86 percentage of change
Interval -7.06 to 4.15
|
SECONDARY outcome
Timeframe: From baseline to week 3Outcome measures
| Measure |
Plant Sterols-enriched Soya Beverage Provided by Vitasoy
n=97 Participants
Daily consumption of 2g of plant sterols as provided by one pack of 250 ml of plant sterols-enriched soya beverage for consecutive 3 weeks, each pack consumed once with main meal (i.e breakfast, lunch or dinner).
Plant sterols-enriched soya beverage: the study product is a 2g plant sterols-enriched in 250ml soya beverage
|
Soya Beverage Provided by Vitasoy
n=96 Participants
Daily consumption of one pack of 250 ml of soya beverage (without plant sterols) for consecutive 3 weeks, each pack consumed once with main meal (i.e breakfast, lunch or dinner).
Soya beverage: the placebo product is a 250 ml soya beverage
|
|---|---|---|
|
Change of Triglycerides (TAG) Via Blood Test at Baseline and Week 3
|
0.00 percentage of change
Interval -18.64 to 21.15
|
-1.88 percentage of change
Interval -17.21 to 19.26
|
SECONDARY outcome
Timeframe: From baseline to week 3Outcome measures
| Measure |
Plant Sterols-enriched Soya Beverage Provided by Vitasoy
n=97 Participants
Daily consumption of 2g of plant sterols as provided by one pack of 250 ml of plant sterols-enriched soya beverage for consecutive 3 weeks, each pack consumed once with main meal (i.e breakfast, lunch or dinner).
Plant sterols-enriched soya beverage: the study product is a 2g plant sterols-enriched in 250ml soya beverage
|
Soya Beverage Provided by Vitasoy
n=96 Participants
Daily consumption of one pack of 250 ml of soya beverage (without plant sterols) for consecutive 3 weeks, each pack consumed once with main meal (i.e breakfast, lunch or dinner).
Soya beverage: the placebo product is a 250 ml soya beverage
|
|---|---|---|
|
Change of Serum Creatinine Via Blood Test at Baseline and Week 3
|
0 percentage of change
Interval -4.0 to 6.0
|
0 percentage of change
Interval -4.0 to 4.0
|
SECONDARY outcome
Timeframe: From baseline to week 3Outcome measures
| Measure |
Plant Sterols-enriched Soya Beverage Provided by Vitasoy
n=97 Participants
Daily consumption of 2g of plant sterols as provided by one pack of 250 ml of plant sterols-enriched soya beverage for consecutive 3 weeks, each pack consumed once with main meal (i.e breakfast, lunch or dinner).
Plant sterols-enriched soya beverage: the study product is a 2g plant sterols-enriched in 250ml soya beverage
|
Soya Beverage Provided by Vitasoy
n=96 Participants
Daily consumption of one pack of 250 ml of soya beverage (without plant sterols) for consecutive 3 weeks, each pack consumed once with main meal (i.e breakfast, lunch or dinner).
Soya beverage: the placebo product is a 250 ml soya beverage
|
|---|---|---|
|
Changes of Fasting Blood Glucose Via Blood Test at Baseline and Week 3
|
0.0 percentage of change
Interval -4.3 to 4.1
|
0.0 percentage of change
Interval -4.2 to 2.2
|
SECONDARY outcome
Timeframe: From baseline to week 3Outcome measures
| Measure |
Plant Sterols-enriched Soya Beverage Provided by Vitasoy
n=98 Participants
Daily consumption of 2g of plant sterols as provided by one pack of 250 ml of plant sterols-enriched soya beverage for consecutive 3 weeks, each pack consumed once with main meal (i.e breakfast, lunch or dinner).
Plant sterols-enriched soya beverage: the study product is a 2g plant sterols-enriched in 250ml soya beverage
|
Soya Beverage Provided by Vitasoy
n=96 Participants
Daily consumption of one pack of 250 ml of soya beverage (without plant sterols) for consecutive 3 weeks, each pack consumed once with main meal (i.e breakfast, lunch or dinner).
Soya beverage: the placebo product is a 250 ml soya beverage
|
|---|---|---|
|
Changes of Cardiometabolic Risk Factors Via Measuring Anthropometry at Baseline and Week 3
Median percentage change of Body weight
|
-0.1 percentage of change
Interval -0.8 to 0.9
|
0.2 percentage of change
Interval -0.6 to 1.0
|
|
Changes of Cardiometabolic Risk Factors Via Measuring Anthropometry at Baseline and Week 3
Median percentage change of Waist circumference
|
0 percentage of change
Interval -2.0 to 3.0
|
0 percentage of change
Interval -3.0 to 3.0
|
|
Changes of Cardiometabolic Risk Factors Via Measuring Anthropometry at Baseline and Week 3
Median percentage change of Hip circumference
|
0 percentage of change
Interval -1.0 to 1.0
|
0 percentage of change
Interval -1.0 to 1.0
|
SECONDARY outcome
Timeframe: From baseline to week 3Outcome measures
| Measure |
Plant Sterols-enriched Soya Beverage Provided by Vitasoy
n=98 Participants
Daily consumption of 2g of plant sterols as provided by one pack of 250 ml of plant sterols-enriched soya beverage for consecutive 3 weeks, each pack consumed once with main meal (i.e breakfast, lunch or dinner).
Plant sterols-enriched soya beverage: the study product is a 2g plant sterols-enriched in 250ml soya beverage
|
Soya Beverage Provided by Vitasoy
n=96 Participants
Daily consumption of one pack of 250 ml of soya beverage (without plant sterols) for consecutive 3 weeks, each pack consumed once with main meal (i.e breakfast, lunch or dinner).
Soya beverage: the placebo product is a 250 ml soya beverage
|
|---|---|---|
|
Changes of Cardiometabolic Risk Factors Via Measuring Blood Pressure at Baseline and Week 3
Median percentage change of Sys. blood pressure
|
-1 percentage of change
Interval -6.0 to 2.0
|
-2 percentage of change
Interval -5.0 to 2.0
|
|
Changes of Cardiometabolic Risk Factors Via Measuring Blood Pressure at Baseline and Week 3
Median percentage change of Dia. blood pressure
|
-3 percentage of change
Interval -7.0 to 1.0
|
-3 percentage of change
Interval -6.0 to 1.0
|
SECONDARY outcome
Timeframe: From baseline to week 3Outcome measures
| Measure |
Plant Sterols-enriched Soya Beverage Provided by Vitasoy
n=98 Participants
Daily consumption of 2g of plant sterols as provided by one pack of 250 ml of plant sterols-enriched soya beverage for consecutive 3 weeks, each pack consumed once with main meal (i.e breakfast, lunch or dinner).
Plant sterols-enriched soya beverage: the study product is a 2g plant sterols-enriched in 250ml soya beverage
|
Soya Beverage Provided by Vitasoy
n=95 Participants
Daily consumption of one pack of 250 ml of soya beverage (without plant sterols) for consecutive 3 weeks, each pack consumed once with main meal (i.e breakfast, lunch or dinner).
Soya beverage: the placebo product is a 250 ml soya beverage
|
|---|---|---|
|
Changes of Cardiometabolic Risk Factors Via Measuring Body Temperature at Baseline and Week 3
|
-0.3 percentage of body temperature change
Interval -0.5 to 0.0
|
-0.3 percentage of body temperature change
Interval -0.5 to 0.0
|
SECONDARY outcome
Timeframe: From baseline to week 3Outcome measures
| Measure |
Plant Sterols-enriched Soya Beverage Provided by Vitasoy
n=92 Participants
Daily consumption of 2g of plant sterols as provided by one pack of 250 ml of plant sterols-enriched soya beverage for consecutive 3 weeks, each pack consumed once with main meal (i.e breakfast, lunch or dinner).
Plant sterols-enriched soya beverage: the study product is a 2g plant sterols-enriched in 250ml soya beverage
|
Soya Beverage Provided by Vitasoy
n=95 Participants
Daily consumption of one pack of 250 ml of soya beverage (without plant sterols) for consecutive 3 weeks, each pack consumed once with main meal (i.e breakfast, lunch or dinner).
Soya beverage: the placebo product is a 250 ml soya beverage
|
|---|---|---|
|
Changes of Musculoskeletal-related Traits Via Measuring Hand Grip Strength at Baseline and Week 3
|
2 percentage of change
Interval -8.0 to 11.0
|
0 percentage of change
Interval -12.0 to 10.0
|
SECONDARY outcome
Timeframe: From baseline to week 3Outcome measures
| Measure |
Plant Sterols-enriched Soya Beverage Provided by Vitasoy
n=97 Participants
Daily consumption of 2g of plant sterols as provided by one pack of 250 ml of plant sterols-enriched soya beverage for consecutive 3 weeks, each pack consumed once with main meal (i.e breakfast, lunch or dinner).
Plant sterols-enriched soya beverage: the study product is a 2g plant sterols-enriched in 250ml soya beverage
|
Soya Beverage Provided by Vitasoy
n=93 Participants
Daily consumption of one pack of 250 ml of soya beverage (without plant sterols) for consecutive 3 weeks, each pack consumed once with main meal (i.e breakfast, lunch or dinner).
Soya beverage: the placebo product is a 250 ml soya beverage
|
|---|---|---|
|
Changes of Musculoskeletal-related Traits Via Measuring Bio-Impedance at Baseline and Week 3
Median % change of Bioimpedance - Fat percentage
|
-1.0 percentage of change
Interval -4.1 to 1.8
|
-0.8 percentage of change
Interval -3.6 to 2.1
|
|
Changes of Musculoskeletal-related Traits Via Measuring Bio-Impedance at Baseline and Week 3
Median % change of Bioimpedance - Fat mass
|
-1.1 percentage of change
Interval -4.8 to 2.1
|
-0.7 percentage of change
Interval -3.3 to 2.9
|
SECONDARY outcome
Timeframe: From baseline to week 3Outcome measures
| Measure |
Plant Sterols-enriched Soya Beverage Provided by Vitasoy
n=98 Participants
Daily consumption of 2g of plant sterols as provided by one pack of 250 ml of plant sterols-enriched soya beverage for consecutive 3 weeks, each pack consumed once with main meal (i.e breakfast, lunch or dinner).
Plant sterols-enriched soya beverage: the study product is a 2g plant sterols-enriched in 250ml soya beverage
|
Soya Beverage Provided by Vitasoy
n=96 Participants
Daily consumption of one pack of 250 ml of soya beverage (without plant sterols) for consecutive 3 weeks, each pack consumed once with main meal (i.e breakfast, lunch or dinner).
Soya beverage: the placebo product is a 250 ml soya beverage
|
|---|---|---|
|
Changes of Musculoskeletal-related Traits Via Measuring Peak Expiratory Flow Rate at Baseline and Week 3
|
0 percentage of change
Interval -5.0 to 7.0
|
-0 percentage of change
Interval -5.0 to 6.0
|
SECONDARY outcome
Timeframe: From baseline to week 3Outcome measures
| Measure |
Plant Sterols-enriched Soya Beverage Provided by Vitasoy
n=98 Participants
Daily consumption of 2g of plant sterols as provided by one pack of 250 ml of plant sterols-enriched soya beverage for consecutive 3 weeks, each pack consumed once with main meal (i.e breakfast, lunch or dinner).
Plant sterols-enriched soya beverage: the study product is a 2g plant sterols-enriched in 250ml soya beverage
|
Soya Beverage Provided by Vitasoy
n=95 Participants
Daily consumption of one pack of 250 ml of soya beverage (without plant sterols) for consecutive 3 weeks, each pack consumed once with main meal (i.e breakfast, lunch or dinner).
Soya beverage: the placebo product is a 250 ml soya beverage
|
|---|---|---|
|
Changes of Musculoskeletal-related Traits Via Measuring 6 Metres Gait Speed at Baseline and Week 3
|
-1.74 percentage of change
Interval -7.8 to 6.81
|
-1.46 percentage of change
Interval -8.41 to 9.44
|
SECONDARY outcome
Timeframe: From baseline to week 3centre of pressure excursion index = CPEI
Outcome measures
| Measure |
Plant Sterols-enriched Soya Beverage Provided by Vitasoy
n=96 Participants
Daily consumption of 2g of plant sterols as provided by one pack of 250 ml of plant sterols-enriched soya beverage for consecutive 3 weeks, each pack consumed once with main meal (i.e breakfast, lunch or dinner).
Plant sterols-enriched soya beverage: the study product is a 2g plant sterols-enriched in 250ml soya beverage
|
Soya Beverage Provided by Vitasoy
n=92 Participants
Daily consumption of one pack of 250 ml of soya beverage (without plant sterols) for consecutive 3 weeks, each pack consumed once with main meal (i.e breakfast, lunch or dinner).
Soya beverage: the placebo product is a 250 ml soya beverage
|
|---|---|---|
|
Changes of Musculoskeletal-related Traits Via Measuring Centre of Pressure Excursion Index for Left and Right Foot at Baseline and Week 3
Median percentage of CPEI change (left foot)
|
0 Percentage of Change
Interval -22.0 to 26.0
|
0 Percentage of Change
Interval -21.0 to 24.0
|
|
Changes of Musculoskeletal-related Traits Via Measuring Centre of Pressure Excursion Index for Left and Right Foot at Baseline and Week 3
Median percentage of CPEI change (right foot)
|
4 Percentage of Change
Interval -17.0 to 22.0
|
-5 Percentage of Change
Interval -20.0 to 23.0
|
Adverse Events
Plant Sterols-enriched Soya Beverage
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Soya Beverage
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Plant Sterols-enriched Soya Beverage
n=100 participants at risk
Daily consumption of 2g of plant sterols as provided by one pack of 250 ml of plant sterols-enriched soya beverage for consecutive 3 weeks, each pack consumed once with main meal (i.e breakfast, lunch or dinner).
Plant sterols-enriched soya beverage: the study product is a 2g plant sterols-enriched in 250ml soya beverage
|
Soya Beverage
n=101 participants at risk
Daily consumption of one pack of 250 ml of soya beverage (without plant sterols) for consecutive 3 weeks, each pack consumed once with main meal (i.e breakfast, lunch or dinner).
Soya beverage: the placebo product is a 250 ml soya beverage
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhea
|
3.0%
3/100 • Participants were asked to complete a questionnaire related to adverse event that happened during the 3 weeks period of consuming soya beverage.
|
0.00%
0/101 • Participants were asked to complete a questionnaire related to adverse event that happened during the 3 weeks period of consuming soya beverage.
|
|
Gastrointestinal disorders
Stomach Bloating
|
0.00%
0/100 • Participants were asked to complete a questionnaire related to adverse event that happened during the 3 weeks period of consuming soya beverage.
|
0.99%
1/101 • Participants were asked to complete a questionnaire related to adverse event that happened during the 3 weeks period of consuming soya beverage.
|
|
Gastrointestinal disorders
Slight hardening of stool during the three weeks period
|
1.0%
1/100 • Participants were asked to complete a questionnaire related to adverse event that happened during the 3 weeks period of consuming soya beverage.
|
0.00%
0/101 • Participants were asked to complete a questionnaire related to adverse event that happened during the 3 weeks period of consuming soya beverage.
|
|
Infections and infestations
Flu
|
1.0%
1/100 • Participants were asked to complete a questionnaire related to adverse event that happened during the 3 weeks period of consuming soya beverage.
|
0.00%
0/101 • Participants were asked to complete a questionnaire related to adverse event that happened during the 3 weeks period of consuming soya beverage.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place