SatiationNCT03539146
Gastrointestinal Tolerance, Satiation and Sensory Acceptance of Yogurts Containing Dietary Fiber and Coffee Cascara Extract
A study testing Dietary fiber in people with Satiation and Gastrointestinal Tolerance, run by National Research Council, Spain at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Satiation, Gastrointestinal Tolerance, Organoleptic Appreciation
- What is being tested?
- Dietary fiber
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- 21 May 2018to 1 Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy volunteers.
Who cannot join
- Food allergies.
- Lactose intolerant.
- Allergic to milk proteins.
- Diagnosed gastrointestinal disease.
- Pregnant, trying to become pregnant or breast feeding.
- Caffeine sensibility.
- Dietary fiber intolerance.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- Dietary fiber, Control yogurt
- Keywords
- byproducts, functional yogurt, satiety, sensory analysis, sustainable health, novel food ingredient
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary fiberOther
Intake of yogurt containing cascara with 0%, 3%, 7%,13% dietary fiber in a crossover design.
Control yogurtOther
Control yogurt
| Study group | Role | What they receive |
|---|---|---|
| Control yogurt | Active comparator | Treatment with a control yogurt with cascara but no dietary fiber. Receives: Other: Control yogurt |
| Yogurt with fiber | Experimental | Treatment with yogurts containing cascara and 3%, 7% and 13% of dietary fiber. Receives: Other: Dietary fiber |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 2 hours after ingestion
Secondary outcomes (2)
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).
Measured: 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.
Measured: up to 5 minutes (At the moment of eating the yogurt)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2018
- Study start21 May 2018
- Primary completion1 Jun 2018
- Study completion1 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SatiationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- 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 blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Research Council, Spain
- Sponsor type
- Other government
- Collaborators
- Madrid Institute of Rural Development, Agronomy and Food Research (IMIDRA)
- Responsible party
- Principal investigator, Maria Dolores del Castillo, National Research Council, Spain
- Investigators
- Maria Dolores del Castillo, PhD, Principal investigator, Institute of Food Science Research (CIAL-CSIC)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03539146
- Sponsor's protocol ID
- AGL2014-57239-R
- Status last verified
- Aug 2018
- First submitted
- 16 May 2018
- Last updated
- 22 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gastrointestinal Tolerance, Satiation and Sensory Acceptance of Yogurts Containing Dietary Fiber and Coffee Cascara Extract.
- ClinicalTrials.gov ID
- NCT03539146
- Acronym / sponsor ID
- AGL2014-57239-R
- Keywords
- byproducts, functional yogurt, satiety, sensory analysis, sustainable health, novel food ingredient
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- National Research Council, SpainOther government
- Collaborators
- Madrid Institute of Rural Development, Agronomy and Food Research (IMIDRA)
- Study start
- 21 May 2018 (actual)
- Primary completion
- 1 Jun 2018 (actual)
- Study completion
- 1 Jun 2018 (actual)
- First posted
- 29 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Control yogurt | Active comparator | Other: Control yogurtTreatment with a control yogurt with cascara but no dietary fiber. |
| Yogurt with fiber | Experimental | Other: Dietary fiberTreatment with yogurts containing cascara and 3%, 7% and 13% of dietary fiber. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy volunteers.
Key exclusion criteria (7 listed)
- Food allergies.
- Lactose intolerant.
- Allergic to milk proteins.
- Diagnosed gastrointestinal disease.
- Pregnant, trying to become pregnant or breast feeding.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dietary fiberIntake of yogurt containing cascara with 0%, 3%, 7%,13% dietary fiber in a crossover design. | Other | Yogurt with fiber |
| Control yogurtControl yogurt | Other | Control yogurt |
Primary outcome
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).
2 secondary outcomes
Satiety
Time frame: At 0, 15, 60, 115, 125, 150, 180, 210 and 240 minutes after breakfast meal.
Sensory acceptance
Time frame: up to 5 minutes (At the moment of eating the yogurt)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria Dolores del Castillo, PhD principal investigator
Institute of Food Science Research (CIAL-CSIC)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary fiber in people with Satiation and Gastrointestinal Tolerance, run by National Research Council, Spain at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gastrointestinal Tolerance (time frame: 2 hours after ingestion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2018.