Fat Quality and Postprandial Inflammation

NCT ID: NCT05674708

Last Updated: 2024-02-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-07
• Study Completion Date: 2024-01-23

Brief Summary

This aim of this randomized controlled postprandial study is to compare the effects of four different far sources (butter, coconut, corn oil and flax seed oil) on postprandial inflammation and metabolic response.

The main questions it aims to answer are:

1. What is the impact of different dietary sources of saturated and polyunsaturated fatty acids on postprandial inflammation?

2. Is the impact of different dietary sources of saturated and polyunsaturated fatty acids on postprandial inflammation mediated by glucose or blood lipids?

3. Can postprandial inflammatory or metabolic response be predicted by individual factors at baseline?

Participants will consume four meals, identical except for the fat source, in random order and sampled for blood and urine for up to 6 hours.

Detailed Description

A randomized crossover single meal study will be conducted, comparing four isocaloric meals. The study will be carried out at two sites; one study center is located in Gothenburg, Sweden (Department of Internal Medicine and Clinical Nutrition at the University of Gothenburg) and one study center in Oslo, Norway (Department of Nutrition, University of Oslo).

A total of 20 healthy adults will be recruited and consume four meals, identical except for the fat source, in random order and sampled for blood and urine for up to 6 hours after. Each of the four meals will be separated by a 1 month washout. Subjects will be asked to abstain from rigorous physical activity, alcohol and high-fat foods the day prior to their test meal days.

Four isocaloric high-fat meals with different fatty acid profiles will be compared:

1. butter

2. coconut oil

3. corn oil

4. flax seed oil

At test meal days, study outcomes will be assessed at baseline (0h, fasting, pre meal), 30 min, 1h, 2h, 4h and at 6h (endpoint). At these timepoints, blood pressure will be measured and blood glucose sampled through capillary blood. At baseline, 2h, 4h and 6h, blood will be drawn by venipuncture. Urine will be collected when the participants need to void.

Blood will be collected and handled according to a standardized protocol to prevent any degradation, before stored in -80°C until analysis. At baseline and endpoint, peripheral blood mononuclear cells from blood samples will be isolated using cell preparation tubes and stored at -80 °C until RNA isolation. Lipids, lipoprotein profile and inflammation markers (e.g. cytokines, chemokines, endothelial factors) will be analyzed in samples from 0, 2, 4 and 6 hours.

Differences between meals in the outcomes will be compared using area under the curve and mixed models effect.

Conditions

Inflammatory Response; Inflammation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Butter

Butter based meal

Group Type: ACTIVE_COMPARATOR

Fat intake

Intervention Type: OTHER

Four different sources of dietary fat

Coconut

Coconut based meal

Group Type: ACTIVE_COMPARATOR

Fat intake

Intervention Type: OTHER

Four different sources of dietary fat

Corn oil

Corn oil based meal

Group Type: ACTIVE_COMPARATOR

Fat intake

Intervention Type: OTHER

Four different sources of dietary fat

Flax seed oil

Flax seed oil based meal

Group Type: ACTIVE_COMPARATOR

Fat intake

Intervention Type: OTHER

Four different sources of dietary fat

Interventions

Fat intake

Four different sources of dietary fat

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• BMI >18.5
• Willingness to eat study meals

Exclusion Criteria

• Diabetes
• Cardiovascular disease
• Cancer
• Dyslipidemia
• Anemia (Hb <100)
• Habitual intake of anti-inflammatory drugs
• Recent weight change (>±5%)
• Pregnancy, lactation
• Current smoking

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Oslo

OTHER

Sponsor Role: collaborator

Chalmers University of Technology

OTHER

Sponsor Role: collaborator

Göteborg University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Linnea Bärebring, PhD

Role: PRINCIPAL_INVESTIGATOR

Göteborg University

Locations

University of Gothenburg

Gothenburg, , Sweden

Countries

Sweden

Other Identifiers

2022-05898-01

Identifier Type: -

Identifier Source: org_study_id