ISRCTN - ISRCTN10600261: A high-calorie challenge in healthy subjects

Plain English Summary

Background and study aims
Regulations for health claims on foods demand a lot of evidence. In the EU, many health claim dossiers from the food industry have been rejected by agencies. This is mainly due to shortcomings in consistent evidence, and partly due to the difficulty in demonstrating specific health benefits of food or food ingredients. In healthy people it can be very difficult to assess changes in health status. The aim of this study is to look into the bodily processes which are most relevant to a healthy metabolism. The aim of this study is to develop a generally accepted standardised test which will be able to demonstrate cause-effect relationships in dietary programs.

Who can participate?
Healthy men and women aged 20-70 years

What does the study involve?
The night before the study day, participants are asked not to eat or drink anything for 10 hours except water. When they attend the study day, a sample of blood is taken before they are asked to drink a high calorie drink. The drink has to be consumed within 5 minutes and was stored in a refrigerator until use. Further blood samples are then taken half and hour, one, two, four, six and eight hours after they have consumed the drink. On the same time points, hunger and fullness levels are measured using a rating scale. In certain patients, blood samples collected before consuming the drink and one, two and four hours afterwards are further analysed.

What are the possible benefits and risks of participating?
There are no direct benefits involved with participating. There is a small risk of pain or bruising from the blood sampling.

Where is the study run from?
Centre for Human Drug Research (Netherlands)

When is the study starting and how long is it expected to run for?
February 2013 to June 2013

Who is funding the study?
1. Ministry for Ecomonic Affairs (Netherlands)
2. Abbott Nutrition (Netherlands)
3. Friesland Campina (Netherlands)
4. Danisco-DuPont (Netherlands)
5. DSM (Netherlands)
6. Nestlé (Netherlands)

Who is the main contact?
Dr Suzan Wopereis

Trial website

Contact information

Type

Scientific

Primary contact

Dr Suzan Wopereis

ORCID ID

http://orcid.org/0000-0001-9612-657X

Contact details

TNO
Utrechtseweg 48
Zeist
3704 HE
Netherlands

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NL43765.056.13

Study information

Scientific title

A high-calorie challenge within the healthy range of the population

Acronym

Study hypothesis

The aim of this study is to investigate whether the high calorie challenge test and the predetermined biomarkers could define the healthy ranges of phenotypic flexibility (focusing on the five defined processes) and could indicate the movement towards a less healthy situation in an apparently healthy population. This study also aims to explore how spectra, measured by Raman spectroscopy, correlate with blood glucose levels that are measured at the same time.

Ethics approval

Independent Ethics Committee (IEC) Assen Foundation Beoordeling Ethiek Biomedisch Onderzoek (Review Ethics Biomedical Research), 22/03/2013, ref: NL43765.056.13

Study design

Single center explorative open-label study non randomised study

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Other

Trial type

Quality of life

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet (Dutch)

Condition

Healthy living

Intervention

Participants are allocated to one of 10 groups according to gender, age and body fat %. All participants undergo a high-calorie challenge test during which a challenge drink is administered. The high-calorie challenge is a 500 mL mixture containing 75g glucose, 20g Protifar (Nutricia), 60 mL palm oil and 320 mL water.

Prior to the challenge (t=0) and after the challenge several blood samples are drawn (up to 8 hours post dose). The challenge drink is consumed after a fasting period of at least 10 hours.

During a sub investigation, 19 subjects also undergo Raman spectroscopy measurements at four different timepoints during the challenge day. Afterwards the spectra measured by Raman spectroscopy were compared with blood glucose levels so that a (possible) correlation could be demonstrated.

Intervention type

Other

Phase

Drug names

Primary outcome measures

Markers of glucose metabolism (including, but not restricted to glucose, glucagon, GLP-1, insulin), markers of lipid metabolism (including, but not limited to triglycerides and cholesterol), hormones and markers for oxidative stress (including, but not limited to adiponectin, gastric inhibitory polypeptide, C-peptide, glutathione ratio), immunology related parameters (including, but not restricted to, C reactive protein, serum amyloid A, soluble intercellular adhesion molecule, soluble vascular cell adhesion molecule), markers of clinical chemistry (including, but not limited to gamma-GT, ALAT, ASAT, ALP, albumin, creatinin), metabolites measured by metabolomics technology in plasma (including, but not restricted to, endogenous metabolites involved in energy metabolism, urea cycle, glucose metabolism, ketone bodies, lipid metabolism and amino acids) are measured using blood samples collected at baseline (overnight fasting), 0.5, 1, 2, 4, 6 and 8 hours after challenge test. Furthermore, the amount of hunger and satiety measured by the ‘’VASfood’’ questionnaire at baseline (overnight fasting), 0.5, 1, 2, 4, 6 and 8 hours after challenge test.

Secondary outcome measures

Glucose is measured using Raman spectroscopy at baseline, 1, 2 and 4 hours after challenge test.

Overall trial start date

01/02/2013

Overall trial end date

26/06/2013

Reason abandoned

Eligibility

Participant 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

Participant type

Healthy volunteer

Age group

Adult

Gender

Male

Target number of participants

100 (10 groups of 10 subjects)

Participant 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)

Recruitment start date

23/03/2013

Recruitment end date

16/05/2013

Locations

Countries of recruitment

Netherlands

Trial participating centre

Centre for Human Drug Research
Zernikedreef 8
Leiden
2333 CL
Netherlands

Sponsor information

Organisation

TNO

Sponsor details

Utrechseweg 48
Zeist
3704 HE
Netherlands

Sponsor type

Research organisation

Website

www.tno.nl

Funders

Funder type

Government

Funder name

Ministry for Ecomonic Affairs (Ministerie van Economische Zaken)

Alternative name(s)

Ministry of Economic Affairs, Netherlands Ministry of Economic Affairs, EZ

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a peer reviewed journal.

IPD Sharing statement:
The datasets generated during and/or analysed during the current study will be stored in a non-publically available repository (Phenotype database; https://dashin.eu/interventionstudies/) and can be made available upon request from suzan.wopereis@tno.nl