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

NCT03539146 | Completed

• 1 other identifier: AGL2014-57239-R
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Satiation; Gastrointestinal Tolerance; Organoleptic Appreciation

Keywords

byproducts; functional yogurt; satiety; sensory analysis; sustainable health; novel food ingredient

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Satiety

  At 0, 15, 60, 115, 125, 150, 180, 210 and 240 minutes after breakfast meal.

• Sensory acceptance

  up to 5 minutes (At the moment of eating the yogurt)

Study Arms (2)

Control yogurt

ACTIVE COMPARATOR

Treatment with a control yogurt with cascara but no dietary fiber.

Other: Control yogurt

Yogurt with fiber

EXPERIMENTAL

Treatment with yogurts containing cascara and 3%, 7% and 13% of dietary fiber.

Other: Dietary fiber

Interventions

Dietary fiber OTHER

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

Yogurt with fiber

Control yogurt OTHER

Control yogurt

Control yogurt

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy volunteers.

You may not qualify if:

• Food allergies.
• Lactose intolerant.
• Allergic to milk proteins.
• Diagnosed gastrointestinal disease.
• Pregnant, trying to become pregnant or breast feeding.
• Caffeine sensibility.
• Dietary fiber intolerance.

Sponsors & Collaborators

• National Research Council, Spain: lead
• Madrid Institute of Rural Development, Agronomy and Food Research (IMIDRA): collaborator

Study Sites (1)

Institute of Food Science Research (CIAL-CSIC)

Madrid, 28049, Spain

Location

MeSH Terms

Interventions

Dietary Fiber

Intervention Hierarchy (Ancestors)

Dietary Carbohydrates; Carbohydrates; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Maria Dolores del Castillo, PhD

  Institute of Food Science Research (CIAL-CSIC)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: May 16, 2018
• First Posted: May 29, 2018
• Study Start: May 21, 2018
• Primary Completion: June 1, 2018
• Study Completion: June 1, 2018
• Last Updated: August 22, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)