A high-calorie challenge in healthy subjects

Completed

• Conditions: Healthy living; Nutritional, Metabolic, Endocrine

• Registration Number: ISRCTN10600261
• Lead Sponsor: TNO

Brief Summary

2017 results in: https://www.ncbi.nlm.nih.gov/pubmed/29225708

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2013-06-26
• Study Start: 2017-05-12
• Last Update Posted: 20 August 2018

Recruitment & Eligibility

• Status: Completed
• Sex: Male
• Target Recruitment: 100

Inclusion Criteria

1. Healthy male / female subjects (ratio: 50-50), 20 to 70 years of age, inclusive. Healthy status is defined by absence of evidence of any active or chronic disease following a detailed medical and surgical history, a complete physical examination including vital signs, hematology and blood chemistry and the health and lifestyle questionnaire.
2. Body fat percentage within limits of predefined recruitment categories
3. Able to participate and willing to give written informed consent and to comply with the study restrictions

Exclusion Criteria

1. Participation in an investigational drug or device study within 3 months prior to screening and / or participation of more than 4 times in the previous
year
2. Loss of blood outside the limits of Sanquin (500 mL) within 3 months prior to screening or not willing to refrain from blood- or plasma donation during the study
3. Average alcohol consumption > 21 units/week for women and > 28 units/week for men
4. Change of smoking habits within two months prior to screening
5. Not having a general practitioner or health insurance
6. Unacceptable concomitant medication use at baseline, e.g., drugs known or likely to interact with the challenge drink or study assessments
7. Use of dietary supplements less than one month prior to Day 1
8. Reported slimming or being on a medically prescribed diet
9. Reported unexplained weight loss or gain of > 2 kg in the last month before screening
10. Reported food allergy or sensitivity for one of the used ingredients
11. Females who are pregnant, planning to be pregnant during the study period, or lactating
12. Not willing to accept information transfer which concerns participation in the study or information regarding health (e.g. laboratory results, findings at
health and lifestyle questionnaire, physical examination or eventual adverse events) to and from their general practitioner
13. Having hypertension defined as a systolic blood pressure (SBP) greater than 140 mmHg or diastolic blood pressure (DBP) greater than 90 mmHg
(assessed three times at five minutes interval). In the case of isolated systolic hypertension in middle aged volunteers (phenotypic group 5 and 10), the
principal investigator will judge whether this condition will cause a clinically significant interference with the study outcome
14. Clinically significant abnormalities, as judged by the Investigator, in laboratory test results. In the case of uncertain or questionable results, tests
performed during screening may be repeated once before determination of eligibility
15. Inappropriate veins for cannula insertion
16. Having a chronic disease related to inflammation (such as arthritis)
17. Having a history or symptoms of any significant disease including (but not limited to), neurological, psychiatric, endocrine, cardiovascular, respiratory,
gastrointestinal, hepatic, or renal disorder
18. Any known factor, condition, or disease that might interfere with treatment compliance, study conduct or interpretation of the results such as drug or
alcohol dependence or psychiatric disease
19. Unwillingness or inability to comply with the study protocol for any other reason

For the sub investigation (Raman spectroscopy):
20. Dark skin color according to the Fitzpatrick skin type scale (type 5 or 6)
21. Abnormalities of the skin at the desired measurement location (upper side of forearm)

Study & Design

• Study Type: Interventional
• Study Design: Not specified