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

November 2, 2022 updated by: Stine Marie Ulven, University of Oslo

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
59

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Oslo, Norway
        • University of Oslo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Healthy
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
Butter with jam and three slices of bread
Other: Cheese
Cheese with jam and three slices of bread
Other: Whipped cream
Whipped cream with jam and three slices of bread
Other: Sour cream
Sour cream with jam and three slices of bread
Experimental: Obese
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
Butter with jam and three slices of bread
Other: Cheese
Cheese with jam and three slices of bread
Other: Whipped cream
Whipped cream with jam and three slices of bread
Other: Sour cream
Sour cream with jam and three slices of bread

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Changes in levels of circulating triglycerides
Time Frame: Measured at baseline and 2,4 and 6 hours after intake of test meal
Measured at baseline and 2,4 and 6 hours after intake of test meal

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Changes in total cholesterol and lipoproteins
Time Frame: Measured at baseline and 2,4 and 6 hours after intake of test meal
Changes in total cholesterol and lipoproteins, such as low-density lipoprotein and high-density lipoprotein
Measured at baseline and 2,4 and 6 hours after intake of test meal
Changes in levels of apolipoproteins
Time Frame: Measured at baseline and 2,4 and 6 hours after intake of test meal
Changes in levels of apolipoproteins, i.e. apo A1, apo B, apo B-48 and apo C-III
Measured at baseline and 2,4 and 6 hours after intake of test meal
Changes in levels of free fatty acids
Time Frame: Measured at baseline and 2,4 and 6 hours after intake of test meal
Measured at baseline and 2,4 and 6 hours after intake of test meal
Changes in levels of circulating inflammatory markers
Time Frame: Measured at baseline and 2,4 and 6 hours after intake of test meal
Changes in levels of inflammatory markers, such as cytokines, acute phase proteins and soluble adhesion molecules
Measured at baseline and 2,4 and 6 hours after intake of test meal
Changes in levels of circulating endotoxins
Time Frame: Measured at baseline and 2,4 and 6 hours after intake of test meal
Measured at baseline and 2,4 and 6 hours after intake of test meal
Changes in gene expressions (mRNA and microRNA) of genes related to lipid metabolism and inflammation in Peripheral Blood Mononuclear Cells (PBMC)
Time Frame: Measured at baseline and 2,4 and 6 hours after intake of test meal
Measured at baseline and 2,4 and 6 hours after intake of test meal
Changes in whole genome transcriptomics in PBMC
Time Frame: Measured at baseline and 2,4 and 6 hours after intake of test meal
Measured at baseline and 2,4 and 6 hours after intake of test meal
Check DNA for Single Nucleotide Polymorphisms related to responses of a high-fat meal
Time Frame: Measured at baseline and 2,4 and 6 hours after intake of test meal
Measured at baseline and 2,4 and 6 hours after intake of test meal
Examine epigenetics through DNA methylation and histone modification
Time Frame: Measured at baseline and 6 hours after intake of test meal
Measured at baseline and 6 hours after intake of test meal
Changes of plasma and urine metabolomics
Time Frame: Measured at baseline and 2,4 and 6 hours after intake of test meal
Changes in levels of metabolites, such as glucose and amino acids
Measured at baseline and 2,4 and 6 hours after intake of test meal
Changes in levels of gut hormones
Time Frame: Measured at baseline and 2,4 and 6 hours after intake of test meal
Changes in levels of gut hormones, such as peptide YY (PYY)
Measured at baseline and 2,4 and 6 hours after intake of test meal
Changes in experiences of hunger and satiety by Visual Analogue Scales (VAS) questionnaire
Time Frame: Measured at baseline and 2,4 and 6 hours after intake of test meal
Measured at baseline and 2,4 and 6 hours after intake of test meal

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Oslo

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
The Research Council of Norway
Tine

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Stine M Ulven, PhD, University of Oslo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 8, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 13, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 18, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 7, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 2, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2016/418/REK sør-øst B

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