Gastrointestinal Tolerance, Satiation and Sensory Acceptance of Yogurts Containing Dietary Fiber and Coffee Cascara Extract

Gastrointestinal Tolerance Clinical Trial

Official title:

Gastrointestinal Tolerance, Satiation and Sensory Acceptance of Yogurts Containing Dietary Fiber and Coffee Cascara Extract.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03539146
• Other study ID #: AGL2014-57239-R
• Status: Completed
• Phase: N/A
• Start date: May 21, 2018
• Est. completion date: June 1, 2018

Study information

• Verified date: August 2018
• Source: National Research Council, Spain
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Gastrointestinal Tolerance
• Organoleptic Appreciation
• Satiation

Intervention

Other:
• Dietary fiber
Intake of yogurt containing cascara with 0%, 3%, 7%,13% dietary fiber in a crossover design.
• Control yogurt
Control yogurt

Locations

Country	Name	City	State
Spain	Institute of Food Science Research (CIAL-CSIC)	Madrid

Sponsors (2)

Lead Sponsor	Collaborator
National Research Council, Spain	Madrid Institute of Rural Development, Agronomy and Food Research (IMIDRA)

Country where clinical trial is conducted

Spain, 

Outcome

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)