Study title
Vette KIP: Exploration of new markers that define impaired metabolic flexibility using an acute postprandial challenge test
Template
Intervention/Observation study
title
Vette KIP: Exploration of new markers that define impaired metabolic flexibility using an acute postprandial challenge test
description
Response patterns of metabolic and inflammatory markers to a high-fat challenge (containing 80 g fat) were compared between 10 apparently healthy men and 10 men with characteristics of the metabolic syndrome (MetS) and in (the same) healthy men before and after a hig-fat high-caloric (HFHC, approximately 1300 kcal/day extra) diet for 4 weeks.
code
9218_Fat_challenge_tests
startDate
2011-06-05 00:00:00.0
Study type
Human Intervention
Objectives
The primary objective of the study was to quantify specific metabolic processes in response to an acute oral fat load and compare these responses in apparently healthy subjects before and after four weeks consuming a high-fat high-caloric diet, between subjects with characteristics of the metabolc syndrome and apparently healthy subjects. Secondary objectives were to assess the reproducibility of responses to the acure oral fat load, and to explore how the colon microbiota is affected by a high-fat high-caloric diet and how changes in microbiota composition relate to baseline changes in inflammatory markers, change in baseline levels of glucose, insulin and blood lipids, and change in intestinal premeability.
Exclusion criteria
Group 1:
1. Participation in any clinical trial including blood sampling and/or administration of substances up to 90 days before Day 01 of this study
2. Participation in any non-invasive clinical trial up to 30 days before Day 01 of this study, including no blood sampling and/or oral, intravenous, inhalatory administration of substances
3. Having a history of medical or surgical events that may significantly affect the study outcome (including (medication for) diabetes, cholesterol lowering medication, eating disorders and/or food allergy (f.i. allergic to cow milk or (pea)nuts)
4. Smoking
5. Alcohol consumption > 28 units/week for males
6. Exercise more than 3 hours/week
7. Reported unexplained weight loss or gain of > 2 kg in the month prior to the pre-study screening
8. Reported slimming or medically prescribed diet
9. Reported vegan, vegetarian or macrobiotic
10. Recent blood donation (<1 month prior to the start of the study)
11. Not willing to give up blood donation during the study.
12. Personnel of TNO , their partner and their first and second degree relatives
13. Not having a general practitioner
14. Not willing to accept information-transfer concerning participation in the study, or information regarding his/her health, like laboratory results, findings at anamnesis or physical examination and eventual adverse events to and from his general practitioner.
Group 2:
1. Participation in any clinical trial including blood sampling and/or administration of substances up to 90 days before Day 01 of this study
2. Participation in any non-invasive clinical trial up to 30 days before Day 01 of this study, including no blood sampling and/or oral, intravenous, inhalatory administration of substances
3. Having a history of medical or surgical events that may significantly affect the study outcome (including (medication for) diabetes, cholesterol lowering medication and/or food allergy (f.i. allergic to cow milk or (pea)nuts)
4. Smoking
5. Alcohol consumption > 28 units/week for males
6. Exercise more than 3 hours/week
7. Reported unexplained weight loss or gain of > 2 kg in the month prior to the pre-study screening
8. Reported slimming or medically prescribed diet
9. Reported vegan, vegetarian or macrobiotic
10. Recent blood donation (<1 month prior to the start of the study)
11. Not willing to give up blood donation during the study.
12. Personnel of TNO , their partner and their first and second degree relatives
13. Not having a general practitioner
14. Not willing to accept information-transfer concerning participation in the study, or information regarding his/her health, like laboratory results, findings at anamnesis or physical examination and eventual adverse events to and from his general practitioner.
Inclusion criteria
Group 1:
1. Healthy as assessed by the
- health and lifestyle questionnaire, (P9218 F02; in Dutch)
- results of the pre-study laboratory tests
2. Males aged 35 and ≤ 50 years at Day 01 of the study
3. Body Mass Index (BMI) 23 and < 30 kg/m2
4. Normal Dutch eating habits as assessed by P9218 F02
5. Voluntary participation
6. Having given written informed consent
7. Non restrained eater, defined as a score of <3.25 in men on the Dutch Restrained Eating Questionnaire as assessed by P9218 F09
8. Willing to comply with the study procedures
9. Appropriate veins for blood sampling/cannula insertion according to TNO
10. Willing to accept use of all nameless data, including publication, and the confidential use and storage of all data for at least 15 years
11. Willing to accept the disclosure of the financial benefit of participation in the study to the authorities concerned.
Group 2:
1. Compromised healthy (having several cardio metabolic risk factors, e.g. metabolic syndrome and/or other cardio-metabolic risk factors, see P9218, paragraph 9.2)
as assessed by the
- health and lifestyle questionnaire, (P9218 F02; in Dutch)
- results of the pre-study laboratory tests
2. Males aged 35 and ≤ 65 years at Day 01 of the study
3. Body Mass Index (BMI) 23 and < 40 kg/m2
4. Normal Dutch eating habits as assessed by P9218 F02
5. Voluntary participation
6. Having given written informed consent
7. Willing to comply with the study procedures
8. Appropriate veins for blood sampling/cannula insertion according to TNO
9. Willing to accept use of all nameless data, including publication, and the confidential use and storage of all data for at least 15 years
10. Willing to accept the disclosure of the financial benefit of participation in the study to the authorities concerned.
