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 : April 19, 2019
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|
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 (Clinical Trial)|
|Actual Enrollment :||12 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Double (Participant, Investigator)|
|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|
Placebo Comparator: Control Canned Tuna
Control Canned Tuna
Other: Control Canned Tuna
Experimental: Enriched Canned Tuna Variety 1
Enriched Canned Tuna Variety 1: Wakame fiber
Other: Enriched Canned Tuna Variety 1
Experimental: Enriched Canned Tuna Variety 2
Enriched Canned Tuna Variety 2: Polyphenols
Other: Enriched Canned Tuna Variety 2
- 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.
- Change from Baseline Blood Hormonal Satiety Markers [ Time Frame: Day 1, 8, 15 ]GLP1, Peptide YY, Ghrelin, Leptin, GIP, Peptide C
- Amount of food consumed in a "food ad libitum" [ Time Frame: Day 1, 8, 15 ]120 min After eating the study product
- Total amount of food consumed in 24h [ Time Frame: Day 1, 8, 15 ]24h Food Record Method
- Change from Baseline Glucose Metabolism Parameters [ Time Frame: Day 1, 8, 15 ]Glucose
- Change from Baseline Lipid Metabolism Parameters [ Time Frame: Day 1, 8, 15 ]Cholesterol, LDL-C, HDL-C, TG
- Anthropometric Parameters [ Time Frame: Day 1, 8, 15 ]Weight and height will be combined to report BMI in kg/m2
- 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.
- Adverse Effects [ Time Frame: Day 1, 8, 15 ]Gastrointestinal Symptoms (Nausea, Diarrhea, Bloating and other disorders)
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
|La Paz University Hospital|
|Principal Investigator:||Carmen Gómez Candela, MD, PhD||La Paz University Hospital|