Gastrointestinal Tolerance Clinical Trial
Official title:
Evaluating the Impact of Incremental Doses of a Sugar Replacer Blend on Gastrointestinal Tolerance in Candies
This study is a randomized, single-blind, crossover trial aiming at evaluating the gastrointestinal tolerance of a sugar replacer blend (inulin + soluble corn fiber + erythritol) at 3 different doses
The study will have a randomized, single-blind, crossover design with 5 visits consisting of one screening visit and 4 study visits (3-14-day interval between the start of each visit) across 2-8 weeks. Participants will be randomized to a test sequence and will consume one control product and 3 test products made with the sugar replacer blend over the course of the study. At each visit, eligible participants will come to the lab between 8-11am, and ~1-2 hours after consuming their usual breakfast at home. After rating the severity of gastrointestinal symptoms, participants will consume one of the investigational products with a drink of water (250ml) and then be free to leave. The severity of 8 gastrointestinal symptoms (Abdominal bloating, Abdominal pain/discomfort, Gas/flatulence, Burping, Reflux (heartburn), Stomach rumbling (borborygmus), Nausea and Vomiting) will be rated at 2, 4, 6, 10 and 24 hours after starting to eat. Over the 24 hour period following consuming the investigational product a Bowel Habit Diary will be kept. For each bowel movement passed during the 24 hour period, participants will be asked to record: the time, if they had to strain, if they experienced discomfort, if they felt there was incomplete evacuation and the consistency of the stool rated using the using the Bristol Stool Scale (BSS). ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Not yet recruiting |
NCT04100460 -
A Double Blind Study on the Gastrointestinal Effects of Arabinoxylan (Leaf Fiber Extract).
|
N/A | |
Completed |
NCT00977964 -
Tolerance of Healthy Term Infants Fed Infant Formulas #3
|
Phase 3 | |
Completed |
NCT03945149 -
A Clinical Trial to Evaluate the Chronic Safety and Tolerance of Turmipure Gold™ in Healthy Subjects
|
N/A | |
Completed |
NCT05369494 -
Infants Fed a Hydrolyzed Infant Formula
|
N/A | |
Completed |
NCT03539146 -
Gastrointestinal Tolerance, Satiation and Sensory Acceptance of Yogurts Containing Dietary Fiber and Coffee Cascara Extract
|
N/A | |
Completed |
NCT02757924 -
Behavior of Infants Fed Formula Supplemented With Prebiotics
|
N/A | |
Completed |
NCT05213494 -
The Effects of Soluble Corn Fiber on Gastrointestinal Tolerance and Fecal Microbiome in Healthy Children
|
N/A | |
Completed |
NCT05051202 -
A Study Assessing the Tolerable Upper Intake Level and Safety of Sugars From Fiber
|
N/A | |
Completed |
NCT01902212 -
Evaluation of an Oral Nutrition Supplement
|
N/A | |
Completed |
NCT03597113 -
Evaluation of Infants Fed an Extensively Hydrolyzed Hypo Allergenic Infant Formula
|
||
Completed |
NCT04745455 -
Gastrointestinal Tolerance and Safety of an Infant Formula Containing Prebiotics, Probiotics and Postbiotics.
|
N/A | |
Completed |
NCT02322138 -
Gastrointestinal Tolerance of Infant Formula
|
N/A | |
Completed |
NCT04945083 -
Evaluation of a High Protein, High Calorie Pudding in Adults With/or at Risk for Malnutrition
|
N/A | |
Completed |
NCT03648255 -
TolerUp Enteral Feeding Protocol
|
||
Completed |
NCT03769012 -
Ability of Beta-glucan Supplementation to Augment Immune Function
|
N/A | |
Completed |
NCT02456831 -
Soy Formula Feedings in Healthy, Term Infants
|
N/A | |
Completed |
NCT03628183 -
Tolerance of Infants Fed a Hydrolysate Formula
|
N/A | |
Completed |
NCT02456805 -
Alternate Formula Feedings in Formula Intolerant Infants
|
N/A | |
Recruiting |
NCT04966299 -
Effect of Daily Erythritol Versus Sucrose Intake Over 5 Weeks on Glucose Tolerance in Adolescents
|
N/A | |
Completed |
NCT02746016 -
Effect of Formula on Infant Behavior
|
N/A |