Impact of Buttermilk on Cholesterol Concentration and Homeostasis (BMILK)

This study has been completed.
Sponsor:
Collaborator:
Dairy Farmers of Canada
Information provided by (Responsible Party):
Benoit Lamarche, Laval University
ClinicalTrials.gov Identifier:
NCT01248026
First received: November 18, 2010
Last updated: January 22, 2013
Last verified: January 2013
  Purpose

The role of low-density lipoprotein cholesterol (LDL-C) in the pathogenesis of cardiovascular disease (CVD) and the clinical benefit of lowering LDL-C in high-risk patients have both been well established. The key contribution of the intestine to whole body cholesterol homeostasis and thus to regulating plasma cholesterol concentrations has also been recognized over the last years. It is now clear that cholesterol homeostasis and hence plasma LDL-C concentrations are maintained by a fine-tuned balance between intestinal cholesterol absorption and endogenous cholesterol synthesis.

Cholesterol is a highly hydrophobic molecule and for that reason, its absorption is almost entirely dependent on its solubilizing capacity in bile acid micelles within the intestine. Recent in vitro studies from our laboratory have shown that buttermilk, a unique by-product of butter manufacturing resulting from the churning of cream, has a strong inhibitory effect on cholesterol micelle solubility. This phenomenon is likely due to the presence of unique milk fat globule membrane (MFGM) fragments present in buttermilk that are produced during the manufacturing of dairy cream into butter. Most of the work done so far on the subject has focused on phospholipids purified from MFGM, while overlooking the complex and entire MFGM mixture of bioactive proteins and polar lipids found in buttermilk. To the best of our knowledge, no study has yet documented the impact of whole buttermilk on plasma cholesterol concentration in human.

The general objective of this research project is to investigate for the first time the impact of buttermilk on plasma cholesterol and other risk factors for CVD in humans. More specifically, we propose to investigate the impact of buttermilk consumption on plasma LDL-C and other CVD risk factors as well as on plasma surrogates of cholesterol absorption and synthesis.


Condition Intervention
Cardiovascular Disease
Other: Buttermilk

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Impact of Buttermilk on Cholesterol Concentration and Homeostasis

Resource links provided by NLM:


Further study details as provided by Laval University:

Primary Outcome Measures:
  • Change in plasma LDL-Cholesterol concentrations [ Time Frame: At the beginning of the study and the end of the 2 four-week periods ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in blood lipids (Total cholesterol, HDL-Cholesterol, Triglycerides) [ Time Frame: At the beginning of the study and the end of the 2 four-week periods ] [ Designated as safety issue: No ]
  • Change in blood pressure [ Time Frame: At the beginning of the study and the end of the 2 four-week periods ] [ Designated as safety issue: No ]
  • Change in surrogates of cholesterol absorption and synthesis [ Time Frame: At the beginning of the study and the end of the 2 four-week periods ] [ Designated as safety issue: No ]
  • Change in anthropometric measures (waist and hip circumferences) [ Time Frame: At the beginning of the study and the end of the 2 four-week periods ] [ Designated as safety issue: No ]

Enrollment: 42
Study Start Date: January 2011
Study Completion Date: December 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Buttermilk Other: Buttermilk

Consumption of the 2 experimental periods

  1. buttermilk (45 g/d)
  2. placebo (45 g/d,)
Other Name: chocolat buttermilk ready-to-use pouches
Placebo Comparator: Placebo Other: Buttermilk

Consumption of the 2 experimental periods

  1. buttermilk (45 g/d)
  2. placebo (45 g/d,)
Other Name: chocolat buttermilk ready-to-use pouches

Detailed Description:

The proposed research will be undertaken as a double-blind randomized cross-over study with participants being subjected to 2 consecutive treatments of 4 weeks each, in random order, during which they will consume 45g of buttermilk and a macro- and micronutrient matching placebo. The treatments will be different in their content of MFGM (present in buttermilk, absent in placebo). Buttermilk and placebo will be fully characterized and formulated in ready-to-use pouches, each pouch containing 22.5 g of artificially flavored products that will have to be mixed in a fixed amount of water for consumption. Participants will have to consume two pouches every day. Based on a 2500 kcal/day regimen, we have calculated that these placebo and buttermilk formulation will contribute to approximately 200 kcal (from 5% and 10%) of the daily energy intake of participants, who will be asked to maintain other aspects of their nutritional habits constant throughout the study.

Fluctuations in female hormones have been shown to influence metabolic variables. For that reason, outcomes at the end of each dietary phase will be measured during the follicular phase of menstrual cycle (day 3 to day 9) in pre-menopausal women. This is another argument for using a 4-wk intervention, which essentially corresponds to the mean duration of the menstrual cycle of most women. Pre-menopausal women will start the first diet during the first week of their menstrual cycle.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy men and women aged between 18 and 65 years
  • For pre-menopausal women: regular menstrual cycle for the last 3 months (25- 35 days), using or not contraceptive agents
  • LDL-Cholesterol concentration between 3.2 and 4.5 mmol/L
  • A 10-yr calculated Framingham risk below 10%.
  • Stable body weight (+/- 2 kg) for 6 months before the beginning of the study
  • Smoking or not

Exclusion Criteria:

  • Previous history of cardiovascular disease, type 2 diabetes and monogenic dyslipidemia
  • Subjects taking medications for hyperlipidemia or hypertension
  • Endocrine disorders
  • Body mass index > 35 kg/m2
  • Food allergies
  • Men and women with extreme nutritional habits such as vegetarism or alcohol consumption > 2 drinks/day
  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: NCT01248026

Locations
Canada
Institute of Nutraceutical and Functional Foods (INAF), Laval University
Quebec, Canada, G1V 0A6
Sponsors and Collaborators
Laval University
Dairy Farmers of Canada
Investigators
Study Director: Patrick Couture, MD, FRCP (C, PhD) Faculty of Medicine, Laval University
  More Information

No publications provided by Laval University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Benoit Lamarche, Professor, Laval University
ClinicalTrials.gov Identifier: NCT01248026     History of Changes
Other Study ID Numbers: INAF-2010-035
Study First Received: November 18, 2010
Last Updated: January 22, 2013
Health Authority: Canada: Health Canada

Keywords provided by Laval University:
Cardiovascular disease
Buttermilk
Blood lipids
Cholesterol absorption
Cholesterol synthesis

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 22, 2014