Skip to main content
OpenTrials
Completed

NCT Number: NCT03539146

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Satiation Gastrointestinal Tolerance Organoleptic Appreciation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institute of Food Science Research (CIAL-CSIC)

Madrid, 28049, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

dietary fiber

Other

Intake of yogurt containing cascara with 0%, 3%, 7%,13% dietary fiber in a crossover design.

Control yogurt

Other

Control yogurt

Primary outcomes

  1. Gastrointestinal Tolerance

    Time frame: 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 outcomes

  1. Satiety

    Time frame: 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).

  2. Sensory acceptance

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

National Research Council, Spain

Other Gov

Collaborators

  • Madrid Institute of Rural Development, Agronomy and Food Research (IMIDRA)

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
May 29, 2018
Registry last updated
Aug 22, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.