Plain English Summary
Not provided at time of registration
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
NL22403.081.08; METC-WU / 08/04
Study information
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
Acronym
Snack study
Study hypothesis
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
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)
Study design
Randomised parallel 2 x 2 factorial single-centre trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Other
Patient information sheet
Condition
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
Phase
Not Applicable
Drug names
Primary outcome measures
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 trial start date
06/10/2008
Overall trial end date
03/12/2008
Reason abandoned
Eligibility
Participant inclusion criteria
1. Age: 18 - 35 years
2. Body mass index (BMI): 18.5 - 23 kg/m^2
3. Healthy men and women
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
80
Participant 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
Recruitment start date
06/10/2008
Recruitment end date
03/12/2008
Locations
Countries of recruitment
Netherlands
Trial participating centre
Wageningen University
Wageningen
6700 EV
Netherlands
Sponsor information
Organisation
Wageningen University (Netherlands)
Sponsor details
Department of Human Nutrition
PO box 8129
Wageningen
6700 EV
Netherlands
Sponsor type
University/education
Website
Funders
Funder type
Research organisation
Funder name
Dutch Nutrition Centre (Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary