Enriched Canned Tuna With Fibre or Polyphenols on Satiety
NCT ID: NCT03921580
Last Updated: 2022-01-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
12 participants
INTERVENTIONAL
2018-06-22
2018-09-01
Brief Summary
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Some studies have shown the contribution of high-fiber foods in the reduction of the cardiovascular risk.
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Detailed Description
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The investigators included 12 participants (6 men and 6 women) between 18 and 55 years (BMI ≥25 and \<30 kg / m2). All volunteers will be randomized into 3 study groups, and participants will receive the 3 different study products in order during the 3 experimental phases.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
OTHER
DOUBLE
Study Groups
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Control Canned Tuna
Control Canned Tuna
Control Canned Tuna
210 g/day
Enriched Canned Tuna Variety 1
Enriched Canned Tuna Variety 1: Wakame fiber
Enriched Canned Tuna Variety 1
210 g/day
Enriched Canned Tuna Variety 2
Enriched Canned Tuna Variety 2: Polyphenols
Enriched Canned Tuna Variety 2
210 g/day
Interventions
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Control Canned Tuna
210 g/day
Enriched Canned Tuna Variety 1
210 g/day
Enriched Canned Tuna Variety 2
210 g/day
Eligibility Criteria
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Inclusion Criteria
* Body Mass Index (BMI) ≥25 and \<30 kg/m2.
* Adequate cultural level and understanding for the clinical trial.
* Signed informed consent
Exclusion Criteria
* Subjects diagnosed with Diabetes Mellitus.
* Subjects with dyslipidemia on pharmacological treatment
* Subjects with hypertension on pharmacological treatment
* Subjects with established diagnosis of eating disorder
* Smokers or those subjects with high alcohol consumption (\> 2-3 servings/ day in men and\> 1 serving/day in women (1 serving = 1 glass of wine or 1 bottle of beer)
* Subjects under pharmacological treatment (except oral contraceptives)
* Subjects with large weight fluctuations of more than 4 kg or who have undergone in six months a weight loss diet
* Subjects with sensory problems
* Subjects with gastrointestinal diseases that affect the digestion or absorption of nutrients
* Pregnant or breastfeeding women
* Women with menstrual irregularities (absence of menstrual cycle at least 2 months)
* Subjects with intense physical activity.
* Subjects with food allergies to meals included in breakfast, study product or lunch or that reject their consumption
* Subjects with a diagnosis of celiac disease or a gluten intolerance
18 Years
55 Years
ALL
Yes
Sponsors
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Friobas Basilio S.L.
UNKNOWN
Instituto de Investigación Hospital Universitario La Paz
OTHER
Responsible Party
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Principal Investigators
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Carmen Gómez Candela, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
La Paz University Hospital
Locations
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La Paz University Hospital
Madrid, , Spain
Countries
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Other Identifiers
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5048
Identifier Type: -
Identifier Source: org_study_id
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