A high-calorie challenge in healthy subjects

Mise à jour : Il y a 4 ans
Référence : ISRCTN10600261

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Extrait

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


Critère d'inclusion

  • Healthy living

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