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

Primary Purpose

Overweight

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Control Canned Tuna
Enriched Canned Tuna Variety 1
Enriched Canned Tuna Variety 2
Sponsored by
Instituto de Investigación Hospital Universitario La Paz
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Overweight focused on measuring Satiety, Polyphenols, Fibre, Visual Analogue Scale, Cross-over, Tuna

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • La Paz University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Experimental

Arm Label

Control Canned Tuna

Enriched Canned Tuna Variety 1

Enriched Canned Tuna Variety 2

Arm Description

Control Canned Tuna

Enriched Canned Tuna Variety 1: Wakame fiber

Enriched Canned Tuna Variety 2: Polyphenols

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
Amount of food consumed in a "food ad libitum"
120 min After eating the study product
Total amount of food consumed in 24h
24h Food Record Method
Change from Baseline Glucose Metabolism Parameters
Concentration of Glucose
Change from Baseline Lipid Metabolism Parameters
Concentration of Cholesterol, LDL-C, HDL-C, TAG
Anthropometric Parameters
Weight and height will be combined to report BMI in kg/m2
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.
Adverse Effects
Number of participants gastrointestinal symptoms (Nausea, Diarrhea, Bloating and other disorders)

Full Information

First Posted
April 16, 2019
Last Updated
January 12, 2022
Sponsor
Instituto de Investigación Hospital Universitario La Paz
Collaborators
Friobas Basilio S.L.
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1. Study Identification

Unique Protocol Identification Number
NCT03921580
Brief Title
Enriched Canned Tuna With Fibre or Polyphenols on Satiety
Acronym
SACIATUN
Official Title
Pilot Study to Evaluate the Satiating Effect of Enriched Canned Tuna With Fibre or Polyphenols in a Group of Healthy Overweight Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
June 22, 2018 (Actual)
Primary Completion Date
July 6, 2018 (Actual)
Study Completion Date
September 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Instituto de Investigación Hospital Universitario La Paz
Collaborators
Friobas Basilio S.L.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight
Keywords
Satiety, Polyphenols, Fibre, Visual Analogue Scale, Cross-over, Tuna

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control Canned Tuna
Arm Type
Placebo Comparator
Arm Description
Control Canned Tuna
Arm Title
Enriched Canned Tuna Variety 1
Arm Type
Experimental
Arm Description
Enriched Canned Tuna Variety 1: Wakame fiber
Arm Title
Enriched Canned Tuna Variety 2
Arm Type
Experimental
Arm Description
Enriched Canned Tuna Variety 2: Polyphenols
Intervention Type
Other
Intervention Name(s)
Control Canned Tuna
Intervention Description
210 g/day
Intervention Type
Other
Intervention Name(s)
Enriched Canned Tuna Variety 1
Intervention Description
210 g/day
Intervention Type
Other
Intervention Name(s)
Enriched Canned Tuna Variety 2
Intervention Description
210 g/day
Primary Outcome Measure Information:
Title
Change from Baseline Satiety Hunger Assessment
Description
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.
Time Frame
Day 1, 8, 15
Secondary Outcome Measure Information:
Title
Change from Baseline Blood Hormonal Satiety Markers
Description
Concentration of Glucagon-like peptide-1 (GLP-1), Peptide tyrosine-tyrosine (YY), Ghrelin, Leptin, Ghrelin, Leptin, Gastric Inhibitory Peptide (GIP), Peptide C
Time Frame
Day 1, 8, 15
Title
Amount of food consumed in a "food ad libitum"
Description
120 min After eating the study product
Time Frame
Day 1, 8, 15
Title
Total amount of food consumed in 24h
Description
24h Food Record Method
Time Frame
Day 1, 8, 15
Title
Change from Baseline Glucose Metabolism Parameters
Description
Concentration of Glucose
Time Frame
Day 1, 8, 15
Title
Change from Baseline Lipid Metabolism Parameters
Description
Concentration of Cholesterol, LDL-C, HDL-C, TAG
Time Frame
Day 1, 8, 15
Title
Anthropometric Parameters
Description
Weight and height will be combined to report BMI in kg/m2
Time Frame
Day 1, 8, 15
Title
Sensory Perception Test
Description
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.
Time Frame
Day 1, 8, 15
Title
Adverse Effects
Description
Number of participants gastrointestinal symptoms (Nausea, Diarrhea, Bloating and other disorders)
Time Frame
Day 1, 8, 15

10. Eligibility

Sex
All
Gender Based
Yes
Gender Eligibility Description
6 men and 6 women
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carmen Gómez Candela, MD, PhD
Organizational Affiliation
La Paz University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
La Paz University Hospital
City
Madrid
Country
Spain

12. IPD Sharing Statement

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