Gastrointestinal Tolerance Clinical Trial
Official title:
Gastrointestinal Tolerance, Satiation and Sensory Acceptance of Yogurts Containing Dietary Fiber and Coffee Cascara Extract.
Verified date | August 2018 |
Source | National Research Council, Spain |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Coffee processing byproducts, such as coffee cascara (outer skin and pulp of the coffee berry), have potential health promoting properties due to the presence of bioactive compounds. Its use as a novel food ingredient is a means of valorizing this fractioin in the elaboration of functional yogurts. The addition of cascara extract in yogurt affects its texture quality. The addition of dietary fiber can help regain the structure of the yogurt's gel. However, secondary gastrointestinal effects associated with acute fiber ingestion must be considered.The aim of this clinical trial is to study the gastrointestinal tolerance, satiation and sensory acceptance of yogurts containing both coffee cascara extract and different doses of commercial soluble dietary fiber.
Status | Completed |
Enrollment | 40 |
Est. completion date | June 1, 2018 |
Est. primary completion date | June 1, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Healthy volunteers. Exclusion Criteria: - Food allergies. - Lactose intolerant. - Allergic to milk proteins. - Diagnosed gastrointestinal disease. - Pregnant, trying to become pregnant or breast feeding. - Caffeine sensibility. - Dietary fiber intolerance. |
Country | Name | City | State |
---|---|---|---|
Spain | Institute of Food Science Research (CIAL-CSIC) | Madrid |
Lead Sponsor | Collaborator |
---|---|
National Research Council, Spain | Madrid Institute of Rural Development, Agronomy and Food Research (IMIDRA) |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Gastrointestinal Tolerance | 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). | 2 hours after ingestion | |
Secondary | Satiety | 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). | At 0, 15, 60, 115, 125, 150, 180, 210 and 240 minutes after breakfast meal. | |
Secondary | Sensory acceptance | 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. | up to 5 minutes (At the moment of eating the yogurt) |
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