Hummus for Health: Dietary Quality and Health Outcomes in Toddlers

Obesity Clinical Trial

Official title:

Hummus for Health: Dietary Quality and Health Outcomes in Toddlers

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02696278
• Other study ID #: 47364-I
• Secondary ID: H-38273
• Status: Terminated
• Phase: N/A
• First received: December 31, 2015
• Last updated: July 13, 2017
• Start date: March 2016
• Est. completion date: June 2017

Study information

• Verified date: July 2017
• Source: Baylor College of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this study is to examine the effect of increasing children's intake of fiber and unsaturated fat, through daily servings of hummus and vegetables, on their microbiome profile.

Description:

Population: The investigators will recruit 104 children ages 12-24 months from daycare centers in the Houston and surrounding areas.

Study design: The study will be conducted at daycare centers and will consist of three phases

• a 'lead in period' (two weeks) where baseline measurements will be taken followed by an 'Introductory period' (three weeks) where the new food will be introduced on three days during snack time for three weeks. The introductory phase will be followed by the 'intervention period' (three weeks) where children will receive daily servings of hummus and vegetables.

Lead in period (two weeks): Two 24-hour dietary recalls will be conducted on each child (parent-report); one 24-hour dietary recall (over a weekend) will be conducted on each parent (self-report). Three dirty diapers will be collected within the time span of a week for microbiome analysis.

Introductory period (three weeks): Since children typically take several introductions of a new food to accept it, and the investigators wish to ensure a high acceptance of hummus, the investigators will spend three weeks introducing the food. The food will be provided on three days during snack time for three weeks. Prior to introducing the food, children will receive a 'lesson' involving information about vegetables using a combination of songs, rhymes and craft activities. Following the lesson, hummus and vegetables will be provided in the hummus group; vegetables only in the control group. Hummus will be provided in a pre-packaged 2 ounce serving cup; vegetables will conform to age-appropriate servings designated by the American Academy of Pediatrics (AAP) and will consist of soft vegetables (e.g., winter squash) and lightly steamed, but chilled, hard vegetables (e.g., carrots, broccoli).

Intervention period (three weeks): Similar to the introductory period, a serving of either hummus and vegetables or vegetables only will be provided to the children during snack time. The food will be provided daily for three weeks. In the final week of the intervention period, two 24-hour dietary recalls (one weekday and one weekend) will be conducted on the child (parent-report). In addition, one weekend 24-hour dietary recall will be conducted on the parent (self-report). Three dirty diapers will be collected on the child during the final week for microbiome analysis.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 139
• Est. completion date: June 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Months to 24 Months

Eligibility

Inclusion Criteria:

• Children between the ages of 12 and 24 month old.

• Children attending daycare at least 3 days a week.

• Children with a parental-report of being hummus-naive.

Exclusion Criteria:

• Any child following a specific dietary regimen or that has religious restrictions or food allergies that may affect food consumption.

• Children with parent-reported antibiotic use in the previous 6 months.

Related Conditions & MeSH terms

• Obesity

Intervention

Other:
• Lesson about vegetables
During the introductory period, children will receive a lesson about vegetables 3 days a week for 3 weeks.
• Vegetables
During the introductory period, children will be served vegetables 3 days a week for 3 weeks during snack time at their daycare center. During the intervention period, children will receive vegetables everyday for 3 weeks during snack time at their daycare center.
• Hummus
During the introductory period, children will be served hummus, depending on their group assignment, 3 days a week for 3 weeks during snack time at their daycare center. During the intervention period, children will receive hummus, depending on their group assignment, everyday for 3 weeks during snack time at their daycare center.

Locations

Country	Name	City	State
United States	Baylor College of Medicine	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Baylor College of Medicine	Sabra Dipping Company, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Children's Healthy Eating Index total score	Parent-report of 24-hour dietary recalls of the child's consumption will be used for this measure.	8 weeks
Primary	Children's microbiome profile	For this measure stool samples from the children will be collected.	8 weeks
Primary	Children's daily consumption of greens and beans	Parent-report of 24-hour dietary recalls of the child's consumption will be used for this measure.	8 weeks
Primary	Children's daily consumption of vegetables	Parent-report of 24-hour dietary recalls of the child's consumption will be used for this measure.	8 weeks
Primary	Children's daily consumption of unsaturated fats	Parent-report of 24-hour dietary recalls of the child's consumption will be used for this measure.	8 weeks
Secondary	Parent's Healthy Eating Index total score	Self-report of 24-hour dietary recalls of the parent's consumption will be used for this measure.	8 weeks
Secondary	Parent's daily consumption of greens and beans	Self-report of 24-hour dietary recalls of the parent's consumption will be used for this measure.	8 weeks
Secondary	Parent's daily consumption of vegetables	Self-report of 24-hour dietary recalls of the parent's consumption will be used for this measure.	8 weeks
Secondary	Parent's daily consumption of unsaturated fats	Self-report of 24-hour dietary recalls of the parent's consumption will be used for this measure.	8 weeks