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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Satiation, Gastrointestinal Tolerance, Organoleptic Appreciation

Intervention / Treatment
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* Other: Dietary fiber
* Other: Control yogurt


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control yogurt<br>Treatment with a control yogurt with cascara but no dietary fiber. | Other: Control yogurt<br>* Control yogurt<br>|
| Experimental: Yogurt with fiber<br>Treatment with yogurts containing cascara and 3%, 7% and 13% of dietary fiber. | Other: Dietary fiber<br>* Intake of yogurt containing cascara with 0%, 3%, 7%,13% dietary fiber in a crossover design.<br>|

What is the study measuring?
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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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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byproducts, functional yogurt, satiety, sensory analysis, sustainable health, novel food ingredient