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

NCT02836106 | Completed

• 1 other identifier: 2016/418/REK sør-øst B
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy; Overweight; Obesity

Keywords

Healthy Volunteers; Obese Volunteers

Outcome Measures

Primary Outcomes (1)

• Changes in levels of circulating triglycerides

  Measured at baseline and 2,4 and 6 hours after intake of test meal

Secondary Outcomes (12)

• Changes in total cholesterol and lipoproteins

  Measured at baseline and 2,4 and 6 hours after intake of test meal

• Changes in levels of apolipoproteins

  Measured at baseline and 2,4 and 6 hours after intake of test meal

• Changes in levels of free fatty acids

  Measured at baseline and 2,4 and 6 hours after intake of test meal

• Changes in levels of circulating inflammatory markers

  Measured at baseline and 2,4 and 6 hours after intake of test meal

• Changes in levels of circulating endotoxins

  Measured at baseline and 2,4 and 6 hours after intake of test meal

Study Arms (2)

Healthy

EXPERIMENTAL

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.

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

Obese

EXPERIMENTAL

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.

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

Interventions

Butter OTHER

Butter with jam and three slices of bread

Healthy; Obese

Cheese OTHER

Cheese with jam and three slices of bread

Healthy; Obese

Whipped cream OTHER

Whipped cream with jam and three slices of bread

Healthy; Obese

Sour cream OTHER

Sour cream with jam and three slices of bread

Healthy; Obese

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Oslo: lead
• Tine: collaborator
• The Research Council of Norway: collaborator

Study Sites (1)

University of Oslo

Oslo, Norway

Location

Related Publications (2)

• Hansson P, Holven KB, Oyri LKL, Brekke HK, Gjevestad GO, Thoresen M, Ulven SM. Sex differences in postprandial responses to different dairy products on lipoprotein subclasses: a randomised controlled cross-over trial. Br J Nutr. 2019 Oct 14;122(7):780-789. doi: 10.1017/S0007114519001429.

  PMID: 31208475 DERIVED

• Hansson P, Holven KB, Oyri LKL, Brekke HK, Biong AS, Gjevestad GO, Raza GS, Herzig KH, Thoresen M, Ulven SM. Meals with Similar Fat Content from Different Dairy Products Induce Different Postprandial Triglyceride Responses in Healthy Adults: A Randomized Controlled Cross-Over Trial. J Nutr. 2019 Mar 1;149(3):422-431. doi: 10.1093/jn/nxy291.

  PMID: 30759235 DERIVED

MeSH Terms

Conditions

Overweight; Obesity

Interventions

Butter; Cheese

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Study Officials

• Stine M Ulven, PhD

  University of Oslo

  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: Professor

Study Record Dates

• First Submitted: June 8, 2016
• First Posted: July 18, 2016
• Study Start: June 1, 2016
• Primary Completion: April 1, 2017
• Study Completion: April 1, 2017
• Last Updated: November 7, 2022

Record last verified: 2022-11

Locations

NO (1)