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

Not Applicable

Completed

• Conditions: Organoleptic Appreciation; Satiation; Gastrointestinal Tolerance
• Interventions: Other: Dietary fiber; Other: Control yogurt

• Registration Number: NCT03539146
• Lead Sponsor: National Research Council, Spain

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2018-05-16
• Study Start: 2018-05-21
• Study First Submitted QC: 2018-05-25
• Study First Posted: 2018-05-29
• Primary Completion: 2018-06-01
• Study Completion: 2018-06-01
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-20
• Last Update Posted: 2018-08-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Yogurt with fiber	Dietary fiber	Treatment with yogurts containing cascara and 3%, 7% and 13% of dietary fiber.
Control yogurt	Control yogurt	Treatment with a control yogurt with cascara but no dietary fiber.

Primary Outcome Measures

Name	Time	Method
Gastrointestinal Tolerance	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).

Secondary Outcome Measures

Name	Time	Method
Satiety	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	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.

Trial Locations

Locations (1)

Institute of Food Science Research (CIAL-CSIC); 🇪🇸 Madrid, Spain