| - candidate number | 10401 |
| - NTR Number | NTR3091 |
| - ISRCTN | ISRCTN wordt niet meer aangevraagd. |
| - Date ISRCTN created | |
| - date ISRCTN requested | |
| - Date Registered NTR | 3-okt-2011 |
| - Secondary IDs | NL36277.081.11. CCMO |
| - Public Title | Why does the number of bites affects satiation? A possible role for cognition’’. |
| - Scientific Title | Why does the number of bites affects satiation? A possible role for cognition’’. |
| - ACRONYM | MovieStudie |
| - hypothesis | Distraction during consumption leads to a smaller effect of the number of bites on the amount of food intake. |
| - Healt Condition(s) or Problem(s) studied | Overweight, Obesity |
| - Inclusion criteria | 1. Male and female; 2. Age between 18 to 45 years; 3. BMI between 18.5 and 25 kg/m2; 4. Healthy (as judged by the participant). |
| - Exclusion criteria | 1. Smoking (>1 cigarette a day); 2. Current participation in other research from the division of human nutrition (WUR); 3. Pleasantness score of tomato soup < 5, on a 9 point hedonic scale; 4. Thyroid disease; 5. Lack of appetite for any (unknown) reason; 6. Swallowing/eating problems; 7. Energy restricted diet within the last two months; 8. Weight gain or loss of 5 kg or more during the last year; 9. Stomach or bowel disease; 10. Diabetes; 11. Endocrine disorders (other than diabetes and thyroid disease); 12. Hypersensitivity or allergy to some of the ingredients of the test product; 13. Restraint eating (men: score > 2.89; on the Dutch eating behaviour questionnaire). |
| - mec approval received | yes |
| - multicenter trial | no |
| - randomised | yes |
| - masking/blinding | Single |
| - control | Not applicable |
| - group | Crossover |
| - Type | 2 or more arms, randomized |
| - Studytype | intervention |
| - planned startdate | 31-okt-2011 |
| - planned closingdate | 23-dec-2011 |
| - Target number of participants | 55 |
| - Interventions | 1. Distraction vs. attention to food intake; distraction will be through watching a movie; 2. Consumption with low number of bites vs. high number of bites per food unit vs. free consumption. Participants will get a tube in their mouth through with soup is served. In one condition the frequence is regulated, but they can decide on the number of bites. In the free condition they can also regulate the frequency. |
| - Primary outcome | Ad libitum intake. This is registrated by specially designed software. |
| - Secondary outcome | Estimated amount consumed by the subjects. |
| - Timepoints | Six times ad libitum intake during lunch. |
| - Trial web site | N/A |
| - status | planned |
| - CONTACT FOR PUBLIC QUERIES | Dieuwerke Bolhuis |
| - CONTACT for SCIENTIFIC QUERIES | Dieuwerke Bolhuis |
| - Sponsor/Initiator | Wageningen University (WUR) |
| - Funding (Source(s) of Monetary or Material Support) | STW/NWO |
| - Publications | N/A |
| - Brief summary | Rationale: We showed recently that the number of bites (NB) is important in satiation. A relative higher NB (three bites of 5 g vs. one bite of 15 g) resulted in ~22% lower food intake. It is not clear why NB affects satiation. It is possible that a relatively higher NB make people belief that they consume more, which triggers a faster satiation. If this would be the case, than cognition and memory may be important for the effect of NB on satiation. Distraction during consumption impairs memory and cognition, therefore, the state of attention may play a role in the effect of NB on satiation. Objective: The objective of this study to investigate the role of attention on the effect of NB on ad libitum intake. Study design: A 3x2 cross-over intervention study. A low NB condition (LNB), a high NB condition (HNB) and a free NB condition (Free) will be presented in an attentive and distractive state. Bites and intervals are administered and controlled by a pump. Study population: Fifty-five, normal weight, non-smoking male subjects between 18 and 35 years old. Main study parameter: Ad libitum intake of tomato soup in grams. |
| - Main changes (audit trail) | |
| - RECORD | 3-okt-2011 - 21-okt-2011 |
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