Effects of Buttermilk on Serum LDL Cholesterol Concentrations

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by Maastricht University Medical Center.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT01566305
First received: March 27, 2012
Last updated: NA
Last verified: March 2012
History: No changes posted
  Purpose

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.


Condition Intervention
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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Effects of Buttermilk With or Without Lutein-enriched Egg Yolk on the Serum LDL Cholesterol Concentration of Slightly Hypercholesterolaemic Volunteers

Resource links provided by NLM:


Further study details as provided by Maastricht University Medical Center:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]

Enrollment: 108
Study Start Date: October 2010
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Aged between 18 and 70 years
  • Fasting serum total cholesterol between 5.5 - 8.0 mmol/l
  • Fasting plasma glucose < 7.0 mmol/l
  • BMI between 25-30 kg/m2
  • non-smoking
  • Willingness to abstain for the duration of the study from egg consumption

Exclusion Criteria:

  • unstable body weight (weight gain or loss >3 kg in the past 3 months)
  • allergic for eggs or egg-rich products
  • allergic or intolerant for cow-milk (lactose) based products
  • indication for treatment with cholesterol-lowering drugs according to the Dutch Cholesterol Consensus
  • use of medication or a diet known to affect serum lipid or glucose metabolism - active cardiovascular disease (for instance congestive heart failure) or recent (<6 months) event, such as acute myocardial infarction or cerebro-vascular accident
  • not willing to stop the consumption of vitamin supplements, fish oil capsules or products rich in plant stanol or sterol esters 3 weeks before the start of the study
  • men: consumption of >21 alcohol consumptions a week
  • women: consumption of >14 alcohol consumptions a week
  • abuse of drugs
  • pregnant or breastfeeding women
  • participation in another biomedical study within 1 month prior to the screening visit
  • having donated blood (as blood donor) within 1 month prior to the screening visit or planning to do so during the study
  • impossible or difficult venipuncture as evidenced during the screening visits
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01566305

Locations
Netherlands
Maastricht University
Maastricht, Limburg, Netherlands, 6200
Sponsors and Collaborators
Maastricht University Medical Center
Investigators
Principal Investigator: Jogchum Plat, Dr. Maastricht University
  More Information

No publications provided

Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT01566305     History of Changes
Other Study ID Numbers: NL33461.068.10
Study First Received: March 27, 2012
Last Updated: March 27, 2012
Health Authority: The Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Additional relevant MeSH terms:
Cardiovascular Diseases
Hypercholesterolemia
Dyslipidemias
Hyperlipidemias
Lipid Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on October 23, 2014