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Enriched Canned Tuna With Fibre or Polyphenols on Satiety

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ClinicalTrials.gov Identifier: NCT03921580
Recruitment Status : Completed
First Posted : April 19, 2019
Last Update Posted : November 7, 2019
Sponsor:
Collaborator:
Friobas Basilio S.L.
Information provided by (Responsible Party):
Instituto de Investigación Hospital Universitario La Paz

Study Description
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Brief Summary:

The purpose of this study is to evaluate the satiating effects of different canned tuna preserved in olive oil enriched with soluble fiber or polyphenols on overweight subjects (BMI ≥25 and <30 kg / m2).

Some studies have shown the contribution of high-fiber foods in the reduction of the cardiovascular risk.


Condition or disease Intervention/treatment Phase
Overweight Other: Control Canned Tuna Other: Enriched Canned Tuna Variety 1 Other: Enriched Canned Tuna Variety 2 Not Applicable

Detailed Description:

A randomized, cross-over and double-blind pilot study with 3 study arms is being performed to evaluate the satiating properties of different canned tuna preserved in olive oil enriched with soluble fiber or polyphenols on overweight subjects.

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Other
Official Title: Pilot Study to Evaluate the Satiating Effect of Enriched Canned Tuna With Fibre or Polyphenols in a Group of Healthy Overweight Subjects
Actual Study Start Date : June 22, 2018
Actual Primary Completion Date : July 6, 2018
Actual Study Completion Date : September 1, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dietary Fiber

Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Control Canned Tuna
Control Canned Tuna
 Other: Control Canned Tuna
210 g/day
Experimental: Enriched Canned Tuna Variety 1
Enriched Canned Tuna Variety 1: Wakame fiber
 Other: Enriched Canned Tuna Variety 1
210 g/day
Experimental: Enriched Canned Tuna Variety 2
Enriched Canned Tuna Variety 2: Polyphenols
 Other: Enriched Canned Tuna Variety 2
210 g/day


Outcome Measures
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Primary Outcome Measures :
  1. Change from Baseline Satiety Hunger Assessment [ Time Frame: Day 1, 8, 15 ]

    Visual Analogue Scale (VAS). 100mm horizontal line anchored at each end with the extremes of the subjective feeling to be quantified. Subjects are instructed to rate the sensation being experienced according to how they define the line.

    e.g., "not at all hungry" (0mm) and "as hungry as I have ever felt" (100mm). Multiple measures are taken at repeated time intervals described below.



Secondary Outcome Measures :
  1. Change from Baseline Blood Hormonal Satiety Markers [ Time Frame: Day 1, 8, 15 ]
    Concentration of Glucagon-like peptide-1 (GLP-1), Peptide tyrosine-tyrosine (YY), Ghrelin, Leptin, Ghrelin, Leptin, Gastric Inhibitory Peptide (GIP), Peptide C

  2. Amount of food consumed in a "food ad libitum" [ Time Frame: Day 1, 8, 15 ]
    120 min After eating the study product

  3. Total amount of food consumed in 24h [ Time Frame: Day 1, 8, 15 ]
    24h Food Record Method

  4. Change from Baseline Glucose Metabolism Parameters [ Time Frame: Day 1, 8, 15 ]
    Concentration of Glucose

  5. Change from Baseline Lipid Metabolism Parameters [ Time Frame: Day 1, 8, 15 ]
    Concentration of Cholesterol, LDL-C, HDL-C, TAG

  6. Anthropometric Parameters [ Time Frame: Day 1, 8, 15 ]
    Weight and height will be combined to report BMI in kg/m2

  7. Sensory Perception Test [ Time Frame: Day 1, 8, 15 ]
    Questionnaire of analysis of sensory perception of the food study product. Five questions that are valued on a scale of 0% to 100% asking about the taste and smell of the study product: desire with which the product is taken, taste, smell, consistency and what wait for effectiveness.

  8. Adverse Effects [ Time Frame: Day 1, 8, 15 ]
    Number of participants gastrointestinal symptoms (Nausea, Diarrhea, Bloating and other disorders)


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   6 men and 6 women
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Men and women from 18 to 65 years old.
  • Body Mass Index (BMI) ≥25 and <30 kg/m2.
  • Adequate cultural level and understanding for the clinical trial.
  • Signed informed consent

Exclusion Criteria:

  • Subjects with BMI ≥30 or <25 kg /m2
  • 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
Contacts and Locations
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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): NCT03921580


Locations
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Spain
La Paz University Hospital
Madrid, Spain
Sponsors and Collaborators
Instituto de Investigación Hospital Universitario La Paz
Friobas Basilio S.L.
Investigators
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Principal Investigator: Carmen Gómez Candela, MD, PhD La Paz University Hospital
More Information
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Responsible Party: Instituto de Investigación Hospital Universitario La Paz
ClinicalTrials.gov Identifier: NCT03921580    
Other Study ID Numbers: 5048
First Posted: April 19, 2019    Key Record Dates
Last Update Posted: November 7, 2019
Last Verified: June 2018

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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 Instituto de Investigación Hospital Universitario La Paz:
Satiety
Polyphenols
Fibre
 Visual Analogue Scale
Cross-over
Tuna
Additional relevant MeSH terms:
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Overweight
Body Weight