NCT05208346

Brief Summary

The aim of this study is to investigate the postprandial effects of fat content and fatty acid composition of mixed meals on parameters associated with cardiometabolic diseases. Therefore, older subjects with increased risk of cardiometabolic diseases consume 4 mixed meals with 25 or 50 g of either canola or coconut oil. In a postprandial period of 6 hours, outcomes associated with cardiometabolic risk (e.g., triglycerides) are analyzed.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable cardiovascular-diseases

Timeline
Completed

Started Mar 2022

Shorter than P25 for not_applicable cardiovascular-diseases

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 23, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 26, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

March 9, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 18, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 18, 2022

Completed
Last Updated

April 29, 2025

Status Verified

April 1, 2025

Enrollment Period

7 months

First QC Date

November 23, 2021

Last Update Submit

April 24, 2025

Conditions

Cardiovascular DiseasesMetabolic Syndrome

Keywords

Postprandial metabolic events

Outcome Measures

Primary Outcomes (7)

  • Parameters of lipid metabolism in blood I

    Measurement of triglycerides (mg/dl)

    Postprandial period of 6 hours

  • Parameters of lipid metabolism in blood II

    Measurement of total cholesterol (mg/dl)

    Postprandial period of 6 hours

  • Parameters of lipid metabolism in blood III

    Measurement of LDL cholesterol (mg/dl)

    Postprandial period of 6 hours

  • Parameters of lipid metabolism in blood IV

    Measurement of HDL cholesterol (mg/dl)

    Postprandial period of 6 hours

  • Parameters of lipid metabolism in blood VI

    Measurement of free fatty acids (mmol/L)

    Postprandial period of 6 hours

  • Parameters of glucose metabolism in blood I

    Measurement of glucose (mg/dl)

    Postprandial period of 6 hours

  • Parameters of glucose metabolism in blood II

    Measurement of insulin (nmol/L)

    Postprandial period of 6 hours

Secondary Outcomes (7)

  • Assessment of hunger and satiety

    Postprandial period of 6 hours

  • Assessment of gut hormones

    Postprandial period of 6 hours

  • Assessment of attention and memory

    Postprandial period of 6 hours

  • Postprandial endothelial function

    Postprandial period of 6 hours

  • Postprandial inflammation

    Postprandial period of 6 hours

  • +2 more secondary outcomes

Study Arms (4)

Canola oil high-fat

EXPERIMENTAL

Participants randomized to receive a mixed meal with 50 g canola oil

Dietary Supplement: Mixed meals

Coconut oil high-fat

EXPERIMENTAL

Participants randomized to receive a mixed meal with 50 g coconut oil

Dietary Supplement: Mixed meals

Canola oil low-fat

EXPERIMENTAL

Participants randomized to receive a mixed meal with 25 g canola oil

Dietary Supplement: Mixed meals

Coconut oil low-fat

EXPERIMENTAL

Participants randomized to receive a mixed meal with 25 g coconut oil

Dietary Supplement: Mixed meals

Interventions

Mixed mealsDIETARY_SUPPLEMENT

Mixed meals enriched with either 25 or 50 g of canola or coconut oil

Canola oil high-fatCanola oil low-fatCoconut oil high-fatCoconut oil low-fat

Eligibility Criteria

Age60 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • BMI: 27 - 34,9 kg/m2
  • Waist circumference: women ≥ 80 cm, men ≥ 94 cm
  • At least two of the following criteria of metabolic syndrome:
  • Fasting triglycerides in serum: ≥ 150 mg/dl Fasting HDL-Cholesterol in serum: women \< 50 mg/dl, men \< 40 mg/dl Systolic blood pressure: ≥ 130 mmHg, diastolic blood pressure: ≥ 85 mmHg Fasting glucose in plasma: ≥ 100 mg/dL

You may not qualify if:

  • Smoking
  • Diseases that may impact outcome measures (e.g., thyroid diseases, insulin-dependent diabetes mellitus, impaired renal function, tumors, anemia)
  • Intake of immunosuppressives or supplements (e.g., fish oil)
  • Participation in another study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Bonn

Bonn, 53115, Germany

Location

Related Publications (1)

  • Diekmann C, Schiemann TB, Kienes HF, Wiechmann C, Kopp C, Stoffel-Wagner B, Coenen M, Nemeth R, Wagner M, Egert S. Fat Amount Rather Than Fatty Acid Composition Influences Postprandial Hunger, Satiety and Attention in Men and Women with a Risk Phenotype for Cardiometabolic Diseases: A Randomized Crossover Trial. J Nutr. 2026 Jan;156(1):101232. doi: 10.1016/j.tjnut.2025.11.003. Epub 2025 Nov 11.

    PMID: 41232773DERIVED

MeSH Terms

Conditions

Cardiovascular DiseasesMetabolic Syndrome

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Sarah Egert, Prof. Dr.

    University of Bonn

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. Sarah Egert

Study Record Dates

First Submitted

November 23, 2021

First Posted

January 26, 2022

Study Start

March 9, 2022

Primary Completion

October 18, 2022

Study Completion

October 18, 2022

Last Updated

April 29, 2025

Record last verified: 2025-04

Locations

DE(1)