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van CCT (UK)

van CCT (UK)

The effects of high-protein breakfasts.

- candidate number2815
- NTR NumberNTR1095
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR16-okt-2007
- Secondary IDs07-3-080. MEC nr.
- Public TitleThe effects of high-protein breakfasts.
- Scientific TitleThe effects of a specific high protein breakfast on diet-induced thermogenesis and satiety; Effects of adjusted green tea catechins on thermogenesis.
- ACRONYMThe effects of high protein breakfsts.
- hypothesisThe administration of a whey protein/ alphalactalbumine/ green tea mixture to a standardized yogurt breakfast, will cause an increase in post-prandial energy expenditure, due to diet-induced thermogenesis and an increase in satiety within 5 hours.
- Healt Condition(s) or Problem(s) studiedEnergy expenditure
- Inclusion criteriaHealthy men and women, with a Body Mass Index (BMI) between 22-33 kg/m2, and age of 20-60 years.
- Exclusion criteriaExclusion criteria for subjects are apart from age and BMI:
1. smoking;
2. having food allergies (especially milk protein allergies);
3. being on medication (except the use of contraception);
4. excessive alcohol consumption;
5. excessive exercise;
6. not being weight stable;
7. being dietary restraint (assessed by the Three Eating Questionnaire (TFEQ));
8. people who drink more than one cup of coffee per day.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingSingle
- controlPlacebo
- groupCrossover
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 7-jan-2008
- planned closingdate1-apr-2009
- Target number of participants40
- InterventionsSubjects will eat 4 different breakfasts. Subjects will come to the university once a week for 4 consecutive weeks. There energy expenditure will be measured by means of indirect calorimetry (ventilated hood). Also, satiety is measured with visual analog scales. Randomization will determine in which sequence the subjects will receive the interventions. This are the interventions:
1. placebo yogurt (15% proteins, 47% carbohydrates and 38% fat);
2. placebo yogurt + whey protein (41% proteins, 47% carbohydrates and 12% fat);
3. placebo yogurt + alphalactalbumine (41% proteins, 47% carbohydrates and 12% fat);
4. placebo yogurt + green tea catechins (15% proteins, 47% carbohydrates and 38% fat).

The breakfast consists of 20% of the daily energy intake and is subject specific.
- Primary outcome1. Energy expenditure;
2. Satiety, using the Visual Analogue Scale (VAS) score (o to 10, 0= no hunger and 10= extreme hunger).
- Secondary outcomeSubstrate use, indicated by the respiratoy quotient.
- TimepointsOne testday is 5 hours. 30 minutes before the intervention the energy expenditure is measured and after the intervention energy expenditure is measured for 4,5 hours. Satiety is measured every hour and 1 hour after the intervention even every 20 minutes.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT for SCIENTIFIC QUERIESProf. Dr. MS Westerterp-Plantenga
- Sponsor/Initiator Friesland Nutrition
- Funding
(Source(s) of Monetary or Material Support)
Friesland Nutrition
- PublicationsN/A
- Brief summaryHigh protein diets cause a thermogenic effect and increase satiety. When people are satiated, energy intake will be restricted. A positive energy balance, can be prevented because of the addition of extra proteins to the breakfasts. During the next meal energy intake will be less, because people might be satiated and still full. Also the energy expenditure will be increased by the extra proteins which also prevents a positive energy balance. The additional green tea during one of the interventions also causes a thermogenic effect. Green tea contains different components which inhibit particular enzymes. Through this the symphatic activity is increased and also the energy expenditure.
- Main changes (audit trail)
- RECORD16-okt-2007 - 20-mrt-2008

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