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出境医 / 临床实验 / Enriched Canned Tuna With Fibre or Polyphenols on Satiety

Enriched Canned Tuna With Fibre or Polyphenols on Satiety

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.


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

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 Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Other
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
Arms and Interventions
Arm Intervention/treatment
Placebo Comparator: Control Canned Tuna
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
Outcome Measures
Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. Change from Baseline Blood Hormonal Satiety Markers [ 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

  2. Amount of food consumed in a "food ad libitum" [ Time Frame: Day 1, 8, 15 ]
    120 min After eating the study product

  3. Total amount of food consumed in 24h [ Time Frame: Day 1, 8, 15 ]
    24h Food Record Method

  4. Change from Baseline Glucose Metabolism Parameters [ Time Frame: Day 1, 8, 15 ]
    Concentration of Glucose

  5. Change from Baseline Lipid Metabolism Parameters [ Time Frame: Day 1, 8, 15 ]
    Concentration of Cholesterol, LDL-C, HDL-C, TAG

  6. Anthropometric Parameters [ Time Frame: Day 1, 8, 15 ]
    Weight and height will be combined to report BMI in kg/m2

  7. 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.

  8. Adverse Effects [ Time Frame: Day 1, 8, 15 ]
    Number of participants gastrointestinal symptoms (Nausea, Diarrhea, Bloating and other disorders)


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   6 men and 6 women
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations

Locations
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Spain
La Paz University Hospital
Madrid, Spain
Sponsors and Collaborators
Instituto de Investigación Hospital Universitario La Paz
Friobas Basilio S.L.
Investigators
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Principal Investigator: Carmen Gómez Candela, MD, PhD La Paz University Hospital
Tracking Information
First Submitted Date  ICMJE April 16, 2019
First Posted Date  ICMJE April 19, 2019
Last Update Posted Date November 7, 2019
Actual Study Start Date  ICMJE June 22, 2018
Actual Primary Completion Date July 6, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 16, 2019) 		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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 5, 2019)
  • Change from Baseline Blood Hormonal Satiety Markers [ 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
  • 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 ]
    Concentration of Glucose
  • Change from Baseline Lipid Metabolism Parameters [ Time Frame: Day 1, 8, 15 ]
    Concentration of Cholesterol, LDL-C, HDL-C, TAG
  • 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 ]
    Number of participants gastrointestinal symptoms (Nausea, Diarrhea, Bloating and other disorders)
Original Secondary Outcome Measures  ICMJE
 (submitted: April 16, 2019)
  • 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)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Enriched Canned Tuna With Fibre or Polyphenols on Satiety
Official Title  ICMJE Pilot Study to Evaluate the Satiating Effect of Enriched Canned Tuna With Fibre or Polyphenols in a Group of Healthy Overweight Subjects
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Other
Condition  ICMJE Overweight
Intervention  ICMJE
  • Other: Control Canned Tuna
    210 g/day
  • Other: Enriched Canned Tuna Variety 1
    210 g/day
  • Other: Enriched Canned Tuna Variety 2
    210 g/day
Study Arms  ICMJE
  • Placebo Comparator: Control Canned Tuna
    Control Canned Tuna
    Intervention: Other: Control Canned Tuna
  • Experimental: Enriched Canned Tuna Variety 1
    Enriched Canned Tuna Variety 1: Wakame fiber
    Intervention: Other: Enriched Canned Tuna Variety 1
  • Experimental: Enriched Canned Tuna Variety 2
    Enriched Canned Tuna Variety 2: Polyphenols
    Intervention: Other: Enriched Canned Tuna Variety 2
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 16, 2019) 		12
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 1, 2018
Actual Primary Completion Date July 6, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Gender Based Eligibility: Yes
Gender Eligibility Description: 6 men and 6 women
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03921580
Other Study ID Numbers  ICMJE 5048
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Instituto de Investigación Hospital Universitario La Paz
Study Sponsor  ICMJE Instituto de Investigación Hospital Universitario La Paz
Collaborators  ICMJE Friobas Basilio S.L.
Investigators  ICMJE
Principal Investigator: Carmen Gómez Candela, MD, PhD La Paz University Hospital
PRS Account Instituto de Investigación Hospital Universitario La Paz
Verification Date June 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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