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Acceptability and Tolerance of a Protein and Micronutrient Fortified Food

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03041103
Recruitment Status : Completed
First Posted : February 2, 2017
Last Update Posted : October 6, 2017
Sponsor:
Information provided by (Responsible Party):
University of California, Davis

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

Condition or disease Intervention/treatment Phase
Poor Nutrition Other: Food Product 1 Not Applicable

Detailed Description:

Acceptability and tolerance testing will be conducted in 10 healthy male adult volunteers and 10 (40 - 60 years of age), and in children (9-13 years of age). All participants will be asked to consume 50g of a test product every day for 2 weeks for the adult volunteers, while the children will be asked to consume the same product every day for one week. The participants will record amount of daily intake, and will be given an entry and exit surveys. These surveys will include the assessment of potential gastrointestinal changes with daily product intake, and will include questions on how they liked the product. Acceptability will be measured as the number of servings and portion of serving completed each day over the trial period.

In adults only, fasting blood samples and a spot urine will be collected towards preliminary work on potential changes in the metabolome and lipidome with the inclusion of the test product within the habitual diet.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Intervention Model Description: Single arm not blind
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Acceptability and Tolerance of a Protein and Micronutrient Fortified Nutritious Food Product in Californian Adults and Children
Actual Study Start Date : January 31, 2017
Actual Primary Completion Date : June 30, 2017
Actual Study Completion Date : June 30, 2017

Arm Intervention/treatment
Experimental: Adult
Food Product 1:50 grams of fortified nutritious product from legumes administered to adults, for 2 weeks
Other: Food Product 1
50 grams of fortified nutritious product from legumes

Experimental: Children
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
50 grams of fortified nutritious product from legumes




Primary Outcome Measures :
  1. GI function [ Time Frame: at 2 weeks ]
    GI function questionnaire with categorical numerical score



Information from the National Library of Medicine

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Ages Eligible for Study:   9 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

° Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03041103


Locations
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United States, California
Department of Nutrition
Davis, California, United States, 95616
Sponsors and Collaborators
University of California, Davis
Investigators
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Principal Investigator: Carl L Keen, PhD University of California, Davis
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Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT03041103    
Other Study ID Numbers: 985880
First Posted: February 2, 2017    Key Record Dates
Last Update Posted: October 6, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Malnutrition
Nutrition Disorders