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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03539146
Recruitment Status : Completed
First Posted : May 29, 2018
Last Update Posted : August 22, 2018
Sponsor:
Collaborator:
Madrid Institute of Rural Development, Agronomy and Food Research (IMIDRA)
Information provided by (Responsible Party):
Maria Dolores del Castillo, 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.

Condition or disease Intervention/treatment Phase
Satiation Gastrointestinal Tolerance Organoleptic Appreciation Other: Dietary fiber Other: Control yogurt Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
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.

Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: Gastrointestinal Tolerance, Satiation and Sensory Acceptance of Yogurts Containing Dietary Fiber and Coffee Cascara Extract.
Actual Study Start Date : May 21, 2018
Actual Primary Completion Date : June 1, 2018
Actual Study Completion Date : June 1, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dietary Fiber

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.




Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03539146


Locations
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Spain
Institute of Food Science Research (CIAL-CSIC)
Madrid, Spain, 28049
Sponsors and Collaborators
National Research Council, Spain
Madrid Institute of Rural Development, Agronomy and Food Research (IMIDRA)
Investigators
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Principal Investigator: Maria Dolores del Castillo, PhD Institute of Food Science Research (CIAL-CSIC)

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Responsible Party: Maria Dolores del Castillo, Principal Investigator, National Research Council, Spain
ClinicalTrials.gov Identifier: NCT03539146    
Other Study ID Numbers: AGL2014-57239-R
First Posted: May 29, 2018    Key Record Dates
Last Update Posted: August 22, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Maria Dolores del Castillo, National Research Council, Spain:
byproducts
functional yogurt
satiety
sensory analysis
sustainable health
novel food ingredient
Additional relevant MeSH terms:
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Cascara
Cathartics
Gastrointestinal Agents