NCT03041103

Brief Summary

Acceptability and tolerance of a new food product in adults and children.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 31, 2017

Completed
Same day until next milestone

Study Start

First participant enrolled

January 31, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 2, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2017

Completed
Last Updated

October 6, 2017

Status Verified

October 1, 2017

Enrollment Period

5 months

First QC Date

January 31, 2017

Last Update Submit

October 3, 2017

Conditions

Poor Nutrition

Outcome Measures

Primary Outcomes (1)

  • GI function

    GI function questionnaire with categorical numerical score

    at 2 weeks

Study Arms (2)

Adult

EXPERIMENTAL

Food Product 1:50 grams of fortified nutritious product from legumes administered to adults, for 2 weeks

Other: Food Product 1

Children

EXPERIMENTAL

Food Product 1: 50 grams of fortified nutritious product from legumes administered to children 9-13 years of age, for 1 weeks

Other: Food Product 1

Interventions

Food Product 1OTHER

50 grams of fortified nutritious product from legumes

AdultChildren

Eligibility Criteria

Age9 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Male, 40-60 years old
  • Male or Female 9-13 years old
  • Subject is willing and able to comply with the study protocols
  • Subject is willing to consume the test products

You may not qualify if:

  • Allergies or intolerances to peas, legumes, pulses, soy, dairy or wheat/gluten
  • Under current medical supervision
  • Non-English speaking
  • Self-reported history of cardiovascular disease, stroke, cancer, renal, hepatic, or thyroid disease, GI tract disorders, previous GI surgery
  • Currently taking prescription drugs or supplements
  • Daily use of aspirin and or non-steroidal anti-inflammatory medicines.
  • Indications of substance or alcohol abuse within the last 3 years
  • Any supplement use, including multi-vitamin/ mineral, herbal, plant or botanical, fish oil, and oil supplements.
  • Self-reported malabsorption
  • Current enrollee in a clinical research study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Nutrition

Davis, California, 95616, United States

Location

MeSH Terms

Conditions

Malnutrition

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic Diseases

Study Officials

  • Carl L Keen, PhD

    University of California, Davis

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: Single arm not blind
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 31, 2017

First Posted

February 2, 2017

Study Start

January 31, 2017

Primary Completion

June 30, 2017

Study Completion

June 30, 2017

Last Updated

October 6, 2017

Record last verified: 2017-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)