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

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

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.

Study Overview

• Status: Completed
• Conditions: Gastrointestinal Tolerance; Satiation; Organoleptic Appreciation
• Intervention / Treatment: Other: Control yogurt; Other: 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 Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain, 28049
    • Institute of Food Science Research (CIAL-CSIC)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control yogurt; Treatment with a control yogurt with cascara but no dietary fiber.	Other: Control yogurt; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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)

Collaborators and Investigators

• Sponsor: National Research Council, Spain
• Collaborators: Madrid Institute of Rural Development, Agronomy and Food Research (IMIDRA)
• Investigators: Principal Investigator: Maria Dolores del Castillo, PhD, Institute of Food Science Research (CIAL-CSIC)

Study record dates

Study Major Dates

• Study Start (Actual): May 21, 2018
• Primary Completion (Actual): June 1, 2018
• Study Completion (Actual): June 1, 2018

Study Registration Dates

• First Submitted: May 16, 2018
• First Submitted That Met QC Criteria: May 25, 2018
• First Posted (Actual): May 29, 2018

Study Record Updates

• Last Update Posted (Actual): August 22, 2018
• Last Update Submitted That Met QC Criteria: August 20, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: functional yogurt; satiety; byproducts; sensory analysis; sustainable health; novel food ingredient
• Other Study ID Numbers: AGL2014-57239-R

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No