Impact of Buttermilk on Cholesterol Concentration and Homeostasis

NCT01248026 | Completed

• 1 other identifier: INAF-2010-035
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cardiovascular Disease

Keywords

Cardiovascular disease; Buttermilk; Blood lipids; Cholesterol absorption; Cholesterol synthesis

Outcome Measures

Primary Outcomes (1)

• Change in plasma LDL-Cholesterol concentrations

  At the beginning of the study and the end of the 2 four-week periods

Secondary Outcomes (4)

• Change in blood lipids (Total cholesterol, HDL-Cholesterol, Triglycerides)

  At the beginning of the study and the end of the 2 four-week periods

• Change in blood pressure

  At the beginning of the study and the end of the 2 four-week periods

• Change in surrogates of cholesterol absorption and synthesis

  At the beginning of the study and the end of the 2 four-week periods

• Change in anthropometric measures (waist and hip circumferences)

  At the beginning of the study and the end of the 2 four-week periods

Study Arms (2)

Buttermilk

EXPERIMENTAL

Other: Buttermilk

Placebo

PLACEBO COMPARATOR

Other: Buttermilk

Interventions

Buttermilk OTHER

Consumption of the 2 experimental periods 1. buttermilk (45 g/d) 2. placebo (45 g/d,)

Also known as: chocolat buttermilk ready-to-use pouches

Buttermilk; Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Laval University: lead
• Dairy Farmers of Canada: collaborator

Study Sites (1)

Institute of Nutraceutical and Functional Foods (INAF), Laval University

Québec, Quebec, G1V 0A6, Canada

Location

Related Publications (1)

• Conway V, Couture P, Richard C, Gauthier SF, Pouliot Y, Lamarche B. Impact of buttermilk consumption on plasma lipids and surrogate markers of cholesterol homeostasis in men and women. Nutr Metab Cardiovasc Dis. 2013 Dec;23(12):1255-62. doi: 10.1016/j.numecd.2013.03.003. Epub 2013 Jun 17.

  PMID: 23786821 DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

Buttermilk

Intervention Hierarchy (Ancestors)

Fermented Beverages; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Cultured Milk Products; Milk; Fermented Foods; Dairy Products; Food; Food and Beverages

Study Officials

• Patrick Couture, MD, FRCP (C, PhD)

  Faculty of Medicine, Laval University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 18, 2010
• First Posted: November 25, 2010
• Study Start: January 1, 2011
• Primary Completion: August 1, 2011
• Study Completion: December 1, 2011
• Last Updated: January 23, 2013

Record last verified: 2013-01

Locations

CA (1)