Vegetable Intake After Weaning With Vegetables or FruitsVaVoNCT01858337

Mum Can I Have Vegetables Again? Development of Vegetable Preferences

A study testing green beans group, Artichoke group and Apple group in people with Vegetable Intake After Weaning With Vegetables or Fruits and Fruit Intake After Weaning With Vegetables or Fruits, run by Wageningen University at 1 site in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Rationale: Despite the health benefits, children's consumption of vegetables is below the recommendations. Most human food preferences are learned through mere exposure, imitation, and conditioning principles. Read more about this study

Who is it for?: Ages 4 to 6 monthsHealthy volunteers can take part
Conditions the study is for: Vegetable Intake After Weaning With Vegetables or Fruits, Fruit Intake After Weaning With Vegetables or Fruits
What is being tested?: green beans group, Artichoke group and Apple group
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 101 participants
Where: 1 siteNetherlands
Study dates: Feb 2009to Sep 2012
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 4 to 6 months
All sexes
Healthy volunteers accepted
Child

Who may be able to join

Infants between 4 and 6 months of age that are apparently healthy are invited to participate in the study. The parents have to give permission for themselves and for their infant to participate by signing an informed consent. By signing the informed consent the parents also agree to participate in the study for 2 years.

Who cannot join

The parents will not sign the informed consent
The parents have already started weaning their child
The infant has a food allergy or intolerance
The child has medical problems that influences with eating or food digestion. (e.g. schisis, problems with the bowls)
The child has a known cognitive or physical developmental problem, which influences how the child's reaction or facial expressions.

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

Wageningen University
Wageningen, Gelderland, 6703 HD

Other trials in Netherlands

About this study

Official title: Mum Can I Have Vegetables Again? Development of Vegetable Preferences.

Rationale: Despite the health benefits, children's consumption of vegetables is below the recommendations. Most human food preferences are learned through mere exposure, imitation, and conditioning principles. During the last years, it has become clear that the development of food preferences starts very early in life. Furthermore, preferences that are learned early in life, are relatively stable and may track into adulthood. However, it is unclear how vegetable preferences develop from infancy until young childhood. In order to influence vegetable consumption, it is essential to study the opportunities to develop a preference for vegetable products early in childhood.
Objective: The aim of this study is to investigate the effect of repeated exposure to vegetables compared to repeated exposure to fruit during weaning on short and long term vegetable and fruit intake. Furthermore, the stability of the learned fruit or vegetable preferences and the later food preferences are measured (i.e. vegetable, fruits, sweets).
Study design:

In this longitudinal study we will measure the development of preferences for a particular vegetable or fruit type within 4 to 6 months old subjects, during a 19 day exposure period to fruit or vegetables (of which 9 days exposure to the target fruit or vegetable) and 6 months after this exposure period. In addition, we compare the food preferences (fruit, vegetable, sweet foods in general), after 6 months, between infants who were weaned with a variety of fruits and infants who were weaned with a variety of vegetables.

Conditions: Vegetable Intake After Weaning With Vegetables or Fruits, Fruit Intake After Weaning With Vegetables or Fruits
Being tested: green beans group, Artichoke group, Apple group, Plums group
Keywords: weaning, infants, vegetables, repeated-exposure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

green beans groupOther
Infants were weaned with vegetable purees for the first 18 days of weaning. One vegetable type per day. With green beans every other day.
Artichoke groupOther
Infants were weaned with vegetable purees for the first 18 days of weaning. One vegetable type per day. With artichoke every other day.
Apple groupOther
Infants were weaned with fruit purees for the first 18 days of weaning. One fruit type per day. With apple every other day.
Plums groupOther
Infants were weaned with fruit purees for the first 18 days of weaning. One fruit type per day. With Plums every other day.

Study groups in NCT01858337
Study group	Role	What they receive
green beans group,	Experimental	1 of the 2 vegetable groups. The infants were weaned only with vegetables. With green beans every other day and another vegetable on the days in between. Receives: Other: green beans group
Artichoke group	Experimental	1 of the 2 vegetable groups. The infants were weaned only with vegetables. With Artichoke every other day and another vegetable on the days in between Receives: Other: Artichoke group
Apple group	Active comparator	1 of the 2 fruit groups. The infants were weaned only with fruits. With Apple every other day and other fruits on the days in between Receives: Other: Apple group
Plums group	Active comparator	1 of the 2 fruit groups. The infants were weaned only with vegetables. With Plums every other day and other fruits on the days in between Receives: Other: Plums group

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Vegetable and fruit intake
Change in Vegetable and fruit intake from before to after the repeated exposure to it. Measured at day 1 and 2 and day 17 and 18 at the intervention.
Measured: At the first 19 days of weaning (4-6 months of age)
Intake of the target Vegetables and fruits at 12 months of age.
Vegetable and fruit intake at 12 months of age. Measured in the lab. Fruit group received apple, plum and green beans at 3 different days
Measured: 6 months after the intervention. Mean age 12 months.
Green beans and Apple intake at 23 months of age.
Green beans and Apple intake at 23 months of age.
Measured: when infants are 23 months of age

Secondary outcomes (1)

Vegetable and in fruit intake after the repeated exposure
Difference in vegetable intake between vegetable and fruit groups and in fruit intake between the vegetable and fruit groups. Vegetable intake is measured on day 17 and 18 in the vegetable groups and in the fruit groups at day 19 (when fruit groups gets the first vegetable.
Measured: After the repeated exposure period during the first 19 days of weaning

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2009Sep 2012

First posted21 May 2013 (estimated)
Study startFeb 2009
Primary completionSep 2012
Study completionSep 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Vegetable Intake After Weaning With Vegetables or FruitsStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 101 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01858337
Sponsor's protocol ID: NL28886.081.09
Acronym: VaVo
Status last verified: May 2013
First submitted: 3 May 2013
Last updated: 21 May 2013
Results posted: No
Data monitoring committee: Yes

Publications

Barends, C.d.V., J; Mojet, J & de Graaf, C, Effects of repeated exposure to either vegetables or fruits on infant's vegetable and fruit acceptance at the beginning of weaning. Food quality and preference, 29 , 157-165, 2013

Study at a glance

From the registry record, last updated by the sponsor on 21 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Mum Can I Have Vegetables Again? Development of Vegetable Preferences.
ClinicalTrials.gov ID: NCT01858337
Acronym / sponsor ID: VaVo / NL28886.081.09
Conditions: Vegetable Intake After Weaning With Vegetables or Fruits, Fruit Intake After Weaning With Vegetables or Fruits
Keywords: weaning, infants, vegetables, repeated-exposure
Study type: Interventional
Recruitment status: Completed
Enrolment: 101 participants (actual)
Lead sponsor: Wageningen UniversityUniversity, hospital or other
Study start: Feb 2009
Primary completion: Sep 2012 (actual)
Study completion: Sep 2012 (actual)
First posted: 21 May 2013 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Rationale: Despite the health benefits, children's consumption of vegetables is below the recommendations. Most human food preferences are learned through mere exposure, imitation, and conditioning principles. During the last years, it has become clear that the development of food preferences starts very early in life. Furthermore, preferences that are learned early in life, are relatively stable and may track into adulthood. However, it is unclear how vegetable preferences develop from infancy until young childhood. In order to influence vegetable consumption, it is essential to study the opportunities to develop a preference for vegetable products early in childhood.
Objective: The aim of this study is to investigate the effect of repeated exposure to vegetables compared to repeated exposure to fruit during weaning on short and long term vegetable and fruit intake. Furthermore, the stability of the learned fruit or vegetable preferences and the later food preferences are measured (i.e. vegetable, fruits, sweets).
Study design:

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 4

Arm	Type	Receives
green beans group,	Experimental	Other: green beans group1 of the 2 vegetable groups. The infants were weaned only with vegetables. With green beans every other day and another vegetable on the days in between.
Artichoke group	Experimental	Other: Artichoke group1 of the 2 vegetable groups. The infants were weaned only with vegetables. With Artichoke every other day and another vegetable on the days in between
Apple group	Active comparator	Other: Apple group1 of the 2 fruit groups. The infants were weaned only with fruits. With Apple every other day and other fruits on the days in between
Plums group	Active comparator	Other: Plums group1 of the 2 fruit groups. The infants were weaned only with vegetables. With Plums every other day and other fruits on the days in between

Who may qualify

Ages: 4 to 6 months
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (1 listed)

Infants between 4 and 6 months of age that are apparently healthy are invited to participate in the study. The parents have to give permission for themselves and for their infant to participate by signing an informed consent. By signing the informed consent the parents also agree to participate in the study for 2 years.

Key exclusion criteria (5 listed)

The parents will not sign the informed consent
The parents have already started weaning their child
The infant has a food allergy or intolerance
The child has medical problems that influences with eating or food digestion. (e.g. schisis, problems with the bowls)
The child has a known cognitive or physical developmental problem, which influences how the child's reaction or facial expressions.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
green beans groupInfants were weaned with vegetable purees for the first 18 days of weaning. One vegetable type per day. With green beans every other day.	Other	green beans group,
Artichoke groupInfants were weaned with vegetable purees for the first 18 days of weaning. One vegetable type per day. With artichoke every other day.	Other	Artichoke group
Apple groupInfants were weaned with fruit purees for the first 18 days of weaning. One fruit type per day. With apple every other day.	Other	Apple group
Plums groupInfants were weaned with fruit purees for the first 18 days of weaning. One fruit type per day. With Plums every other day.	Other	Plums group

Primary outcome

Change in Vegetable and fruit intake
Time frame: At the first 19 days of weaning (4-6 months of age)
Change in Vegetable and fruit intake from before to after the repeated exposure to it. Measured at day 1 and 2 and day 17 and 18 at the intervention.
Intake of the target Vegetables and fruits at 12 months of age.
Time frame: 6 months after the intervention. Mean age 12 months.
Vegetable and fruit intake at 12 months of age. Measured in the lab. Fruit group received apple, plum and green beans at 3 different days
Green beans and Apple intake at 23 months of age.
Time frame: when infants are 23 months of age
Green beans and Apple intake at 23 months of age.

1 secondary outcome

Vegetable and in fruit intake after the repeated exposure
Time frame: After the repeated exposure period during the first 19 days of weaning

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2013.
Results publicationBarends, C.d.V., J; Mojet, J & de Graaf, C, Effects of repeated exposure to either vegetables or fruits on infant's vegetable and fruit acceptance at the beginning of weaning. Food quality and preference, 29 , 157-165, 2013

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Cees de Graaf, Prof. study director

Wageningen University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 May 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Vegetable and fruit intake (time frame: At the first 19 days of weaning (4-6 months of age)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01858337, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2013.