Postprandial Effects of High-fat Meals With Different Dairy Products on Lipid Metabolism and Inflammation

University of Oslo

Status: Completed

Conditions: Overweight; Healthy; Obesity

Treatments: Other: Whipped cream; Other: Cheese; Other: Sour cream; Other: Butter

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02836106

2016/418/REK sør-øst B

Details and patient eligibility

About

The aim of this project is to elucidate how high-fat meals with different kinds of dairy products affect postprandial responses of lipid metabolism and inflammatory markers in healthy and obese subjects.

Enrollment: 59 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• The study will include both men and women aged 18-70 years with the aim of an even age and gender balance.
• Participants in the healthy group will need to have a body mass index (BMI) between 18.5 - 24.9 kg/m2 and a waist circumference (WC) of <94 cm for men and<80 cm for women.
• Participants in the obese group will need to have a BMI of ≥25 kg/m2 and a waist circumference of ≥94 cm for men and ≥80 cm for women.
• All subjects must be willing to eat three slices of bread with a dairy product and jam as breakfast.

Exclusion criteria

• BMI <18.5 kg/m2 or >25 kg/m2 in the healthy group and <25 kg/m2 in the obese group
• WC ≥94 for men and ≥80 cm for women in the healthy group, <94/80 cm for men/women in the obese group
• Weight change of ± 5 % of body weight in the last three months
• TG ≥1.3 mmol/L in the healthy group
• CRP >10 mg/L
• Total cholesterol >6.1 mmol/L for subjects 18-29 years, >6.9 mmol/L for subjects 30-49 years and >7.8 mmol/L for subjects ≥50 years old
• Blood pressure >160/100 mm Hg
• Comorbidities including diabetes type I and II (blood glucose ≥7 mmol/L fasting), coronary heart disease, haemophilia, anaemia (hemoglobin <120 gram/L), gastro intestinal disease and hyperthyroidism (TSH >4 mU/L)
• Pregnant or lactating
• Allergic or intolerant to gluten, milk protein and/or lactose
• Use of medications affecting lipid metabolism or inflammation
• Unwilling to seponate omega-3 rich supplements four weeks prior to screening and during the study period
• Hormone treatment (stabile dose of contraception or thyroxin for the last three months excepted)
• Blood donation two months prior to test day 1 or during the study period
• Tobacco smoking
• Excessive regular alcohol consumption (>40 grams per day) or prior to the test day

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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59 participants in 2 patient groups

Healthy

Experimental group

Description:

Lean subjects (BMI\<25) with a waist circumference of \<94 cm for men and\<80 cm for women. Subjects will be randomly assigned to eat butter, cheese, whipped cream and sour cream in a cross-over design.

Treatment:

Other: Butter

Other: Sour cream

Other: Whipped cream

Other: Cheese

Obese

Experimental group

Description:

Overweight and obese subjects (BMI≥25) with a waist circumference of ≥94 cm for men and ≥80 cm for women. Subjects will be randomly assigned to eat butter, cheese, whipped cream and sour cream in a cross-over design.

Treatment:

Other: Butter

Other: Sour cream

Other: Whipped cream

Other: Cheese