Effect of Cheese on Cardiovascular Risk

NCT01739153 | Completed

• 1 other identifier: B302
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

The main objective of the current study is to examine whether a high intake of regular-fat cheeses (Danbo and Cheddar) affect blood lipids differently than an isocaloric intake of either other fatty animal food products or of starchy carbohydrates. Furthermore, effects on fat digestibility, blood pressure, anthropometry, bile acid metabolism and insulin sensitivity is investigated. To do this, a randomized crossover intervention study with 3x14 days full diet periods (cheese diet, meat diet or carb diet)will be conducted in 16 postmenopausal women. Between the diet periods there will be at least 14 days of wash-out where the subjects eat their habitual diets. Fasting blood samples will be drawn before and after the diet periods, and also a non-fasting blood sample will be drawn after the diet periods. Furthermore, total feces is collected the last 5 days of each diet period.

Conditions

Hyperlipidemia

Keywords

Dairy; Cheese; Blood lipid concentrations; Blood lipid sizes; Fecal fat; Fat digestibility; bile acids

Outcome Measures

Primary Outcomes (1)

• LDL cholesterol

  fasting, mmol/l

  day 1 and day 14 in each diet period

Secondary Outcomes (7)

• Blood lipid concentrations

  day 1 and day 14 in each diet period

• ApoA1 and ApoB

  day 1 and day 14 in each diet period

• Dietary fat digestibility

  During day 10-14 in each period

• Blood pressure

  day 1 and day 14 in each diet period

• Anthropometry

  day 1 and day 14 in each diet period

Study Arms (3)

CARB diet

EXPERIMENTAL

The CARB diet will be a low-fat diet where cheese is replaced by starchy carbohydrates and lean meat. The CARB diet will have the same protein content (15 E%) and quality as the CHEESE and MEAT diet but a lower fat content (approx. 25 E%) and a correspondingly higher carbohydrate content (approx. 60 E%).

Other: Dietary intervention: CARB (High Carbohydrate intake)

CHEESE diet

EXPERIMENTAL

The CHEESE diet will contain cheese in amounts corresponding to 120 g/day on a 10 MJ diet (approx. 1.8 MJ from cheese). A high dose of cheese is chosen to provoke effects within this short time frame. The cheese types used in this study will be Danbo (45+) and Cheddar (50+) which will be supplied in equal amounts. The CHEESE diet will have the same macronutrient composition as that of the average Danish diet (15 E% from protein, max 35 E% from fat, and max 15 E% from saturated fat).

Other: Dietary intervention: CHEESE (High cheese intake)

MEAT diet

EXPERIMENTAL

The MEAT diet will be a diet without dairy products. In this diet cheese is mainly replaced by high-fat mixed meat products to achieve saturated fat content and protein quality similar to that of the CHEESE diet. The MEAT diet will have the same macronutrient composition as that of the average Danish diet (15 E% from protein, max 35 E% from fat, and max 15 E% from saturated fat).

Other: Dietary intervention: MEAT (High Meat intake)

Interventions

Dietary intervention: CHEESE (High cheese intake) OTHER

CHEESE diet

Dietary intervention: MEAT (High Meat intake) OTHER

MEAT diet

Dietary intervention: CARB (High Carbohydrate intake) OTHER

CARB diet

Eligibility Criteria

• Age: 45 Years - 68 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female gender
• Postmenopausal for \>1 year
• Age 45-68 years
• BMI 25-32 kg/m2
• TC \> 4.5 mmol/L and \< 7 mmol/L
• Systolic blood pressure \<160 mmHg and/or diastolic blood pressure \<100 mmHg

You may not qualify if:

• Chronic diseases (known diabetes; CVD; other chronic diseases which could affect the results of the present study)
• Milk allergy
• Nut allergy
• Use of dietary supplements incl. multivitamins (2 months before and during the entire study period)
• Smoking
• Elite athletes (\>10 hours of strenuous physical activity per week)
• Use of prescription medicine which could affect the results of the present study including systemic glucocorticoids
• Use of lipid-lowering agents
• Stable dose of antihypertensive medication \>3 months before study commencement for subjects with high blood pressure
• Hormone replacement therapy
• Blood donation \<1 month before study commencement and during study period
• Simultaneous participation in other clinical studies
• Inability (physically or psychologically) to comply with the procedures required by the protocol

Sponsors & Collaborators

• University of Copenhagen: lead
• The Danish Dairy Research Foundation, Denmark: collaborator
• Dairy Research Institute: collaborator
• Dairy Farmers of Canada: collaborator
• Centre National Interprofessionel de l'Economie Laitière: collaborator
• Dairy Australia: collaborator
• Nederlandse Zuivel Organisatie: collaborator

Study Sites (1)

Department of Nutrition, Exercise and Sports

Copenhagen, Frederiksberg, 1958, Denmark

Location

Related Publications (1)

• Thorning TK, Raziani F, Bendsen NT, Astrup A, Tholstrup T, Raben A. Diets with high-fat cheese, high-fat meat, or carbohydrate on cardiovascular risk markers in overweight postmenopausal women: a randomized crossover trial. Am J Clin Nutr. 2015 Sep;102(3):573-81. doi: 10.3945/ajcn.115.109116. Epub 2015 Jul 15.

  PMID: 26178720 DERIVED

MeSH Terms

Conditions

Hyperlipidemias

Condition Hierarchy (Ancestors)

Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Arne Astrup, Prof, MD

  Head of Department of Nutrition, Exercise and Sports

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof., MD, Head of Department, Department of Nutrition, Exercise and Sports

Study Record Dates

• First Submitted: November 27, 2012
• First Posted: December 3, 2012
• Study Start: January 1, 2013
• Primary Completion: August 1, 2013
• Study Completion: November 1, 2014
• Last Updated: November 21, 2014

Record last verified: 2014-11

Locations

DK (1)