Condition category
Nutritional, Metabolic, Endocrine
Date applied
14/05/2009
Date assigned
17/06/2009
Last edited
17/06/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.voedingscentrum.nl/Voedingscentrum/English

Contact information

Type

Scientific

Primary contact

Prof Cees de Graaf

ORCID ID

Contact details

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

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

http://www.wageningenuniversiteit.nl/UK/

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

Publication citations

Additional files

Editorial Notes