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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01858337
Other study ID # NL28886.081.09
Secondary ID
Status Completed
Phase N/A
First received May 3, 2013
Last updated May 16, 2013
Start date February 2009
Est. completion date September 2012

Study information

Verified date May 2013
Source Wageningen University
Contact n/a
Is FDA regulated No
Health authority Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

Status Completed
Enrollment 101
Est. completion date September 2012
Est. primary completion date September 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 4 Months to 6 Months
Eligibility Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Basic Science


Related Conditions & MeSH terms

  • Fruit Intake After Weaning With Vegetables or Fruits
  • Vegetable Intake After Weaning With Vegetables or Fruits

Intervention

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

Locations

Country Name City State
Netherlands Wageningen University Wageningen Gelderland

Sponsors (1)

Lead Sponsor Collaborator
Wageningen University

Country where clinical trial is conducted

Netherlands, 

References & Publications (1)

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

Outcome

Type Measure Description Time frame Safety issue
Primary 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. At the first 19 days of weaning (4-6 months of age) No
Primary 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 6 months after the intervention. Mean age 12 months. No
Primary Green beans and Apple intake at 23 months of age. Green beans and Apple intake at 23 months of age. when infants are 23 months of age No
Secondary 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. After the repeated exposure period during the first 19 days of weaning No