Ignite Creation Date:
2025-12-25 @ 3:28 AM
Ignite Modification Date:
2026-02-21 @ 9:29 PM
Study NCT ID:
NCT01566305
Status:
COMPLETED
Last Update Posted:
2018-09-06
First Post:
2012-03-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Buttermilk on Serum LDL Cholesterol Concentrations
Sponsor:
Maastricht University Medical Center
Organization:
Study Overview
Official Title:
The Effects of Buttermilk With or Without Lutein-enriched Egg Yolk on the Serum LDL Cholesterol Concentration of Slightly Hypercholesterolaemic Volunteers
Status:
COMPLETED
Status Verified Date:
2018-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
Study Design:
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.
Study population:
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).
Intervention:
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.
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.
Study Design:
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.
Study population:
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).
Intervention:
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: