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van CCT (UK)

van CCT (UK)

The effect of protein status on food preferences and intake.

- candidate number8398
- NTR NumberNTR2491
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR1-sep-2010
- Secondary IDs10/09 / 32871.081.10 ; MEC Wageningen / ABR
- Public TitleThe effect of protein status on food preferences and intake.
- Scientific TitleThe effect of protein status on food preferences and intake.
- hypothesisThe protein status of an individual effects food preferences and intake. If the protein status is high, choice and intake of high-protein foods will be decreased. If the protein status is low, choice and intake of high-protein foods will be increased.
- Healt Condition(s) or Problem(s) studiedEating behaviour
- Inclusion criteria1. Age: 18-35 years;
2. BMI: 20.0 - 25.0 kg/m2;
3. Healthy (as judged by the participant).
- Exclusion criteria1. Restraint eating (men: score > 2.25; women: score > 2.80);
2. Lack of appetite;
3. Having difficulties with swallowing/eating;
4. Usage of a energy restricted diet during the last two months;
5. Weight loss or weight gain of 5 kg or more during the last two months;
6. Stomach or bowel diseases;
7. Kidney disorders;
8. Diabetes, thyroid disease, other endocrine disorders;
9. Prevalent cardiovascular disease;
10. A systolic blood pressure of ≥ 160 mmHg at screening;
11. Usage of daily medication other than birth control pills;
12. For women: pregnant or lactating;
13. Being a vegetarian;
14. Being allergic/intolerant for products under study;
15. Having participated in studies that have used the LFPQ: RiceTime, LunchTime, Smaak-Geur», SenSation, and ProStudy, or current participation in other research from the division of human nutrition (WUR).
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingSingle
- controlNot applicable
- groupCrossover
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 27-sep-2010
- planned closingdate19-nov-2010
- Target number of participants40
- InterventionsTwo 14-day fully controlled intervention periods differing in dietary protein intake. These interventions involve consumption of individualized, iso-energetic menus providing either 0.5 g protein/kg bodyweight/day (low protein diet) or 2.0 g protein/kg bodyweight/day (high protein diet).
- Primary outcomeThe difference in protein intake (g) during a 2-day ad libitum-phase following the two interventions.
- Secondary outcome1. The difference in energy intake during the 2-day ad libitum-phase following the two interventions;
2. The difference in subjective appetite ratings during the low protein diet and the high protein diet measured with a visual analogue scale (VAS) hourly during the waking hours of a single 24h period on the last day of the normal protein diet and on the first day and last day of the two interventions;
3. The difference on explicit liking (ratings on VAS), explicit wanting (ratings on VAS), implicit wanting (reaction time in food choice), and food preference (frequency) per food category between the 2 interventions measured with the LFPQ;
4. The difference in systolic blood pressure (measured at the end of each intervention) following the two interventions.
- TimepointsEvery participant will visit the laboratory every day during the intervention periods.
- Trial web siteN/A
- statusopen: patient inclusion
- Sponsor/Initiator Wageningen University, Department of Human Nutrition
- Funding
(Source(s) of Monetary or Material Support)
Technologiestichting STW (Stichting Technische Wetenschappen)
- PublicationsN/A
- Brief summaryRationale:
It has been posed that protein intake is tightly regulated in the human body. It has been shown that when subjects have eaten high-protein meals, a significantly greater reduction is seen in liking for high-protein food than for high-carbohydrate foods. In our previous research, we did not observe this effect within one meal. Animal and human studies suggest that energy and macronutrient balance are regulated over a longer period of time.

To determine the effect of protein status on food preferences and intake.

Study design:
The study will consist of two 14-day fully controlled dietary interventions that involve consumption of individualized, isoenergetic menus providing either 0.5 g protein/kg BW/day (low protein diet), or 2.0 g protein/kg BW/day (high protein diet), using a randomized crossover design. The interventions will be followed by a 2-day ad libitum-phase, where protein intake (g) will be measured. Both interventions will be preceded by 2 days on which subjects eat a normal protein diet. The interventions will be separated by a minimum of 1 week washout.

Study population:
The study population will consist of 40 apparently healthy, unrestrained volunteers between the age of 18 and 35 with a normal weight.

Main study parameters/endpoints:
Our main outcome measurement is the difference between protein intake (g) during the 2-day ad libitum-phase following the two interventions.
- Main changes (audit trail)
- RECORD1-sep-2010 - 9-sep-2010

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