Gastrointestinal Tolerance, Satiation and Sensory Acceptance of Yogurts Containing Dietary Fiber and Coffee Cascara Extract
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|ClinicalTrials.gov Identifier: NCT03539146|
Recruitment Status : Completed
First Posted : May 29, 2018
Last Update Posted : August 22, 2018
|Condition or disease||Intervention/treatment||Phase|
|Satiation Gastrointestinal Tolerance Organoleptic Appreciation||Other: Dietary fiber Other: Control yogurt||Not Applicable|
Forty healthy volunteers will be recruited and distributed into 4 groups following a randomized, blind, crossover design. Yogurt formulations will be administered two hours after the ingestion of a standardized breakfast, as a snack. Yogurt formulations include:
- Control cascara yogurt with 0% dietary fiber.
- Cascara yogurt with 3% dietary fiber.
- Cascara yogurt with 7% dietary fiber.
- Cascara yogurt with 13% dietary fiber.
The study will be conducted in 4 sessions, with at least 48h of washout period between treatment days. Data on gastrointestinal tolerance, satiation and sensory acceptance will be taken on the same day of the treatment using online surveys.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Crossover Assignment|
|Intervention Model Description:||
Forty volunteers will be randomly distributed in 4 groups that will follow a sequence of treatments according to a balanced latin square design. Treatment days involve the ingestion in acute conditions of a yogurt formulation with a different dietary fiber dose:
Subjects will have a 48h washout period between treatment days to avoid carry-over effects.
|Primary Purpose:||Basic Science|
|Official Title:||Gastrointestinal Tolerance, Satiation and Sensory Acceptance of Yogurts Containing Dietary Fiber and Coffee Cascara Extract.|
|Actual Study Start Date :||May 21, 2018|
|Actual Primary Completion Date :||June 1, 2018|
|Actual Study Completion Date :||June 1, 2018|
Active Comparator: Control yogurt
Treatment with a control yogurt with cascara but no dietary fiber.
Other: Control yogurt
Experimental: Yogurt with fiber
Treatment with yogurts containing cascara and 3%, 7% and 13% of dietary fiber.
Other: Dietary fiber
Intake of yogurt containing cascara with 0%, 3%, 7%,13% dietary fiber in a crossover design.
- Gastrointestinal Tolerance [ Time Frame: 2 hours after ingestion ]Self reported gastrointestinal symptoms including bloating, nausea, flatulence, cramping, diarrhea, constipation and rumbling. Severity of symptoms will be measured with a 4-point scale (0= none, 1= mild, 2=moderate, 3= severe).
- Satiety [ Time Frame: At 0, 15, 60, 115, 125, 150, 180, 210 and 240 minutes after breakfast meal. ]Self reported sensation of satiety, fullness, thirst, desire to eat food and prospective food consumption. Measurements will be conducted using a 100mm visual analogue scale (VAS).
- Sensory acceptance [ Time Frame: up to 5 minutes (At the moment of eating the yogurt) ]Self reported sensory acceptance of the different yogurts, reporting overall acceptance and liking for the following attributes in a 9 point hedonic scale: appearance, odor, taste and texture.
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): NCT03539146
|Institute of Food Science Research (CIAL-CSIC)|
|Madrid, Spain, 28049|
|Principal Investigator:||Maria Dolores del Castillo, PhD||Institute of Food Science Research (CIAL-CSIC)|