Enriched Canned Tuna With Fibre or Polyphenols on Satiety (SACIATUN)

Pilot Study to Evaluate the Satiating Effect of Enriched Canned Tuna With Fibre or Polyphenols in a Group of Healthy Overweight Subjects

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.

Study Overview

• Status: Completed
• Conditions: Overweight
• Intervention / Treatment: Other: Control Canned Tuna; Other: Enriched Canned Tuna Variety 1; Other: Enriched Canned Tuna Variety 2

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 Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain
    • La Paz University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline Satiety Hunger Assessment	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.	Day 1, 8, 15

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline Blood Hormonal Satiety Markers	Concentration of Glucagon-like peptide-1 (GLP-1), Peptide tyrosine-tyrosine (YY), Ghrelin, Leptin, Ghrelin, Leptin, Gastric Inhibitory Peptide (GIP), Peptide C	Day 1, 8, 15
Amount of food consumed in a "food ad libitum"	120 min After eating the study product	Day 1, 8, 15
Total amount of food consumed in 24h	24h Food Record Method	Day 1, 8, 15
Change from Baseline Glucose Metabolism Parameters	Concentration of Glucose	Day 1, 8, 15
Change from Baseline Lipid Metabolism Parameters	Concentration of Cholesterol, LDL-C, HDL-C, TAG	Day 1, 8, 15
Anthropometric Parameters	Weight and height will be combined to report BMI in kg/m2	Day 1, 8, 15
Sensory Perception Test	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.	Day 1, 8, 15
Adverse Effects	Number of participants gastrointestinal symptoms (Nausea, Diarrhea, Bloating and other disorders)	Day 1, 8, 15

Collaborators and Investigators

• Sponsor: Instituto de Investigación Hospital Universitario La Paz
• Collaborators: Friobas Basilio S.L.

Study record dates

Study Major Dates

• Study Start (Actual): June 22, 2018
• Primary Completion (Actual): July 6, 2018
• Study Completion (Actual): September 1, 2018

Study Registration Dates

• First Submitted: April 16, 2019
• First Submitted That Met QC Criteria: April 16, 2019
• First Posted (Actual): April 19, 2019

Study Record Updates

• Last Update Posted (Actual): January 13, 2022
• Last Update Submitted That Met QC Criteria: January 12, 2022
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Keywords: Satiety; Polyphenols; Visual Analogue Scale; Fibre; Cross-over; Tuna
• Additional Relevant MeSH Terms: Body Weight; Overweight
• Other Study ID Numbers: 5048

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No