The effects of snack consumption during two months on body weight
| ISRCTN | ISRCTN11886432 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11886432 |
| Secondary identifying numbers | NL22403.081.08; METC-WU / 08/04 |
- Submission date
- 14/05/2009
- Registration date
- 17/06/2009
- Last edited
- 03/06/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Cees de Graaf
Scientific
Scientific
Wageningen University
Department of Human Nutrition
PO Box 8129
Wageningen
6700 EV
Netherlands
Study information
| Study design | Randomised parallel 2 x 2 factorial single-centre trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Other |
| Scientific title | The effects of two months of snack consumption during a meal or in between meals on energy balance: a randomised parallel 2 x 2 factorial single-centre trial |
| Study acronym | Snack study |
| Study objectives | There is controversy about the influences of snack consumption on energy balance. Short term intervention studies demonstrate no energy intake compensation, which suggests that eating in between meals result in higher daily energy intake. Epidemiological studies however, do not show a clear relation between snack consumption and overweightness. The aim of the current experiment is to investigate the long term effects of moments of snack consumption on compensation behaviour and energy balance in a free living situation. In addition, we will focus on the effects of energy density on energy balance. |
| Ethics approval(s) | Medical Ethical Testing Committee (METC), Wageningen University (t.a.v. Prof. CPGM de Groot), Department of Human Nutrition, approved in May 2008 (ref: NL22403.081.08) |
| Health condition(s) or problem(s) studied | Obesity, overweight |
| Intervention | Snacks are consumed either with a meal or between meals and the snacks have either a low (less than 4 kJ/g) or high (greater than 12 kJ/g) energy density. Subjects consume the snacks daily for 8 weeks. The energy content of the snacks in each study group is 25% of the participant's daily energy needs. |
| Intervention type | Other |
| Primary outcome measure | Change in weight after two months of intervention. The change in weight will be compared between the 4 groups. Body weight is assessed in week 1 and in week 8 on a digital scale to the nearest 0.01 kg. Body weight is also assessed twice a week during the 8 weeks of intervention to keep track of changes over time. |
| Secondary outcome measures | 1. Observed energy intake on two days in week 1 and on two days in week 8 2. Body composition assessed with air displacement plethysmography on one morning in week 1 and on one morning in week 8 3. Level of physical activity is assessed on 7 days in week 1 and 7 days in week 8 by means of an activity diary and by a pedometer |
| Overall study start date | 06/10/2008 |
| Completion date | 03/12/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 80 |
| Total final enrolment | 82 |
| Key inclusion criteria | 1. Age: 18 - 35 years 2. Body mass index (BMI): 18.5 - 23 kg/m^2 3. Healthy men and women |
| Key exclusion criteria | 1. Weight change of greater than 1 kg in last three months 2. Smoking 3. Following an energy restricted diet during the last six months 4. Gastro-intestinal diseases 5. Diabetes, thyroid diseases, or any other endocrine disorders 6. Lack of appetite for any (unknown) reason 7. Restraint eating (men: score greater than 2.26; women: score greater than 2.80 on Dutch Eating Behaviour Questionnaire (DEBQ), norm table of 2005) 8. Participation in a different study, performed by the Department of Human Nutrition |
| Date of first enrolment | 06/10/2008 |
| Date of final enrolment | 03/12/2008 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Wageningen University
Wageningen
6700 EV
Netherlands
6700 EV
Netherlands
Sponsor information
Wageningen University (Netherlands)
University/education
University/education
Department of Human Nutrition
PO box 8129
Wageningen
6700 EV
Netherlands
| Website | http://www.wageningenuniversiteit.nl/UK/ |
|---|---|
"ROR" |
https://ror.org/04qw24q55 |
Funders
Funder type
Research organisation
Dutch Nutrition Centre (Netherlands)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/02/2010 | 03/06/2020 | Yes | No |
Editorial Notes
03/06/2020: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
