La Paz University Hospital
Madrid, Spain
NCT Number: NCT03921580
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.
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Notify Me18 year–55 year
All sexes
Interventional
Not applicable
Madrid, Spain
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
210 g/day
210 g/day
210 g/day
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.
Time frame: Day 1, 8, 15
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
120 min After eating the study product
Time frame: Day 1, 8, 15
24h Food Record Method
Time frame: Day 1, 8, 15
Concentration of Glucose
Time frame: Day 1, 8, 15
Concentration of Cholesterol, LDL-C, HDL-C, TAG
Time frame: Day 1, 8, 15
Weight and height will be combined to report BMI in kg/m2
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.
Time frame: Day 1, 8, 15
Number of participants gastrointestinal symptoms (Nausea, Diarrhea, Bloating and other disorders)
Instituto de Investigación Hospital Universitario La Paz
Other
Pilot Study to Evaluate the Satiating Effect of Enriched Canned Tuna With Fibre or Polyphenols in a Group of Healthy Overweight Subjects
Acronym: SACIATUN
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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