Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 7:22 PM
Ignite Modification Date:
2025-12-24 @ 7:22 PM
NCT ID:
NCT03041103
Brief Summary:
Acceptability and tolerance of a new food product in adults and children.
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.
Study:
NCT03041103
Study Brief:
Protocol Section:
NCT03041103