Effects of Buttermilk on Serum LDL Cholesterol Concentrations
|ClinicalTrials.gov Identifier: NCT01566305|
Recruitment Status : Unknown
Verified March 2012 by Maastricht University Medical Center.
Recruitment status was: Active, not recruiting
First Posted : March 29, 2012
Last Update Posted : March 29, 2012
Rationale and objective:
Based on the results of a pilot study, the objective of the present study is to evaluate whether buttermilk lower serum LDL cholesterol concentrations and can prevent the serum LDL cholesterol raising effects of eggs.
The study has a randomized placebo-controlled factorial 2x2 design. The total study duration is 14 weeks, consisting of a 2 weeks run-in period and a 12 weeks experimental period. Subjects will be stratified for age, gender and BMI over the experimental groups.
One hundred and eight healthy male and female subjects, aged 18-70 years, with slightly elevated serum total cholesterol concentrations (5.5-8.0 mmol/l).
During the entire study period, volunteers are instructed to consume a diet according to the Dutch dietary guidelines (35 en% fat (10 en% saturated fat), 50-55 en% carbohydrates). During the two weeks run-in period all subjects will drink daily at lunch 100 mL skimmed milk. During the 12 weeks experimental period, a first group of subjects will continue drinking the skimmed milk (control group), while a second group will consume a low-fat buttermilk, a third group skimmed milk enriched with egg-yolk, and a fourth group egg-yolk incorporated into a low-fat buttermilk based beverage. The egg-yolk will be enriched in lutein. Whole egg consumption (others than provided by us) is not allowed during the entire study.
Main study parameters/endpoints:
Measurements will be performed during the run-in period (days 0, 11 and 14) and during the experimental period (days 56, 95 and 98). The main effects (egg-yolk and buttermilk consumption) will be calculated as the absolute differences between values obtained at the end of the experimental (average days 95 and 98) and run-in (average days 11 and 14) periods. The primary endpoint is the change in serum LDL cholesterol concentrations. Secondary endpoints are changes in serum total and HDL cholesterol, triacylglycerol, apoA-I, apoB and hsCRP concentrations.
|Condition or disease||Intervention/treatment||Phase|
|Hypercholesterolemia Buttermilk Dietary Modification Cardiovascular Disease||Dietary Supplement: Buttermilk without added egg-yolk Dietary Supplement: Buttermilk with added egg yolk Dietary Supplement: Skimmed milk with added egg-yolk Dietary Supplement: Skimmed milk without added egg yolk||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||108 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||The Effects of Buttermilk With or Without Lutein-enriched Egg Yolk on the Serum LDL Cholesterol Concentration of Slightly Hypercholesterolaemic Volunteers|
|Study Start Date :||October 2010|
|Estimated Primary Completion Date :||July 2012|
|Experimental: Buttermilk with added egg yolk||
Dietary Supplement: Buttermilk with added egg yolk
Buttermilk with added egg yolk
|Experimental: Buttermilk without added egg-yolk||
Dietary Supplement: Buttermilk without added egg-yolk
Buttermilk without added egg-yolk
|Experimental: Skimmed milk with added egg-yolk||
Dietary Supplement: Skimmed milk with added egg-yolk
Skimmed milk with added egg-yolk
|Placebo Comparator: Skimmed milk without added egg yolk||
Dietary Supplement: Skimmed milk without added egg yolk
Skimmed milk without added egg yolk
- Change in serum LDL cholesterol concentrations [ Time Frame: LDL cholesterol will be measured at day 0, 11, 14, 56, 95 and 98 during the study ]
- Changes in serum total and HDL cholesterol, triacylglycerol, apoA-I, apoB and hsCRP concentrations [ Time Frame: Serum total and HDL cholesterol, triacylglycerol, apoA-I and ApoB will be measured at day 0, 11, 14, 56, 95 and 98 during the study. hsCRP concentrations will be measured at day 11, 14, 95 and 98. ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01566305
|Maastricht, Limburg, Netherlands, 6200|
|Principal Investigator:||Jogchum Plat, Dr.||Maastricht University|