Enriched Canned Tuna With Fibre or Polyphenols on Satiety

Overweight Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03921580
• Other study ID #: 5048
• Status: Completed
• Phase: N/A
• Start date: June 22, 2018
• Est. completion date: September 1, 2018

Study information

• Verified date: June 2018
• Source: Instituto de Investigación Hospital Universitario La Paz
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: September 1, 2018
• Est. primary completion date: July 6, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Overweight

Intervention

Other:
• Control Canned Tuna
210 g/day
• Enriched Canned Tuna Variety 1
210 g/day
• Enriched Canned Tuna Variety 2
210 g/day

Locations

Country	Name	City	State
Spain	La Paz University Hospital	Madrid

Sponsors (2)

Lead Sponsor	Collaborator
Instituto de Investigación Hospital Universitario La Paz	Friobas Basilio S.L.

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Amount of food consumed in a "food ad libitum"	120 min After eating the study product	Day 1, 8, 15
Secondary	Total amount of food consumed in 24h	24h Food Record Method	Day 1, 8, 15
Secondary	Change from Baseline Glucose Metabolism Parameters	Concentration of Glucose	Day 1, 8, 15
Secondary	Change from Baseline Lipid Metabolism Parameters	Concentration of Cholesterol, LDL-C, HDL-C, TAG	Day 1, 8, 15
Secondary	Anthropometric Parameters	Weight and height will be combined to report BMI in kg/m2	Day 1, 8, 15
Secondary	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
Secondary	Adverse Effects	Number of participants gastrointestinal symptoms (Nausea, Diarrhea, Bloating and other disorders)	Day 1, 8, 15