Clinical trial NCT03539146: Gastrointestinal Tolerance, Satiation and Sensory Acceptance of Yogurts Containing Dietary Fiber and Coffee Cascara Extract
Official title: Gastrointestinal Tolerance, Satiation and Sensory Acceptance of Yogurts Containing Dietary Fiber and Coffee Cascara Extract.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Satiation
Gastrointestinal Tolerance
Organoleptic Appreciation
Keywords: byproducts
functional yogurt
satiety
sensory analysis
sustainable health
novel food ingredient
Lead sponsor: National Research Council, Spain
Sponsor class: OTHER_GOV
Collaborators: name: Madrid Institute of Rural Development, Agronomy and Food Research (IMIDRA)
First posted: 2018-05-29
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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:

* Cascara control yogurt with 0% dietary fiber.
* Cascara yogurt with 3% dietary fiber.
* Cascara yogurt with 7% dietary fiber.
* Cascara yogurt with 13% dietary fiber.

Subjects will have a 48h washout period between treatment days to avoid carry-over effects.
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Gastrointestinal Tolerance
timeFrame: 2 hours after ingestion
Secondary outcomes:
measure: Satiety
timeFrame: At 0, 15, 60, 115, 125, 150, 180, 210 and 240 minutes after breakfast meal.
measure: Sensory acceptance
timeFrame: up to 5 minutes (At the moment of eating the yogurt)
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Institute of Food Science Research (CIAL-CSIC)
Study officials:
affiliation: Institute of Food Science Research (CIAL-CSIC)
name: Maria Dolores del Castillo, PhD
role: PRINCIPAL_INVESTIGATOR
References: