Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Enriched Canned Tuna With Fibre or Polyphenols on Satiety

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

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.


Layout table for study information
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

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




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 ]
    GLP1, Peptide YY, Ghrelin, Leptin, 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 ]
    Glucose

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

  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 ]
    Gastrointestinal Symptoms (Nausea, Diarrhea, Bloating and other disorders)



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.


Layout table for eligibility information
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

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
Layout table for location information
Spain
La Paz University Hospital
Madrid, Spain
Sponsors and Collaborators
Instituto de Investigación Hospital Universitario La Paz
Friobas Basilio S.L.
Investigators
Layout table for investigator information
Principal Investigator: Carmen Gómez Candela, MD, PhD La Paz University Hospital

Layout table for additonal information
Responsible Party: Instituto de Investigación Hospital Universitario La Paz
ClinicalTrials.gov Identifier: NCT03921580     History of Changes
Other Study ID Numbers: 5048
First Posted: April 19, 2019    Key Record Dates
Last Update Posted: April 19, 2019
Last Verified: June 2018

Layout table for additional information
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:
Layout table for MeSH terms
Overweight
Body Weight
Signs and Symptoms