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OpenTrials
Completed

NCT Number: NCT03041103

Acceptability and Tolerance of a Protein and Micronutrient Fortified Food

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

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Key information

Age range

9 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Nutrition

Davis, California, 95616, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

° 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.

Treatment and study plan

Food Product 1

Other

50 grams of fortified nutritious product from legumes

Primary outcomes

  1. GI function

    Time frame: at 2 weeks

    GI function questionnaire with categorical numerical score

Sponsors and collaborators

Lead sponsor

University of California, Davis

Other

Registry information

Official study title

Acceptability and Tolerance of a Protein and Micronutrient Fortified Nutritious Food Product in Californian Adults and Children

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Feb 2, 2017
Registry last updated
Oct 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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