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

Study website

Contact information

Prof Cees de Graaf
Scientific

Wageningen University
Department of Human Nutrition
PO Box 8129
Wageningen
6700 EV
Netherlands

Study information

Study designRandomised parallel 2 x 2 factorial single-centre trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Other
Study typeOther
Scientific titleThe 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 acronymSnack study
Study objectivesThere 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) studiedObesity, overweight
InterventionSnacks 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 typeOther
Primary outcome measureChange 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 measures1. 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 date06/10/2008
Completion date03/12/2008

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants80
Total final enrolment82
Key inclusion criteria1. Age: 18 - 35 years
2. Body mass index (BMI): 18.5 - 23 kg/m^2
3. Healthy men and women
Key exclusion criteria1. 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 enrolment06/10/2008
Date of final enrolment03/12/2008

Locations

Countries of recruitment

  • Netherlands

Study participating centre

Wageningen University
Wageningen
6700 EV
Netherlands

Sponsor information

Wageningen University (Netherlands)
University/education

Department of Human Nutrition
PO box 8129
Wageningen
6700 EV
Netherlands

Website http://www.wageningenuniversiteit.nl/UK/
ROR logo "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 shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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.