OverweightSACIATUNNCT03921580
Enriched Canned Tuna With Fibre or Polyphenols on Satiety
A study testing Enriched Canned Tuna Variety 1 and Enriched Canned Tuna Variety 2 in people with Overweight, run by Instituto de Investigación Hospital Universitario La Paz at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight
- What is being tested?
- Enriched Canned Tuna Variety 1 and Enriched Canned Tuna Variety 2
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteSpain
- Study dates
- 22 Jun 2018to 1 Sep 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Study to Evaluate the Satiating Effect of Enriched Canned Tuna With Fibre or Polyphenols in a Group of Healthy Overweight Subjects
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.
Read the 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.
- Conditions
- Overweight
- Being tested
- Control Canned Tuna, Enriched Canned Tuna Variety 1, Enriched Canned Tuna Variety 2
- Keywords
- Satiety, Polyphenols, Fibre, Visual Analogue Scale, Cross-over, Tuna
- Medical subject headings
- Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control Canned TunaOther
210 g/day
Enriched Canned Tuna Variety 1Other
210 g/day
Enriched Canned Tuna Variety 2Other
210 g/day
| Study group | Role | What they receive |
|---|---|---|
| Control Canned Tuna | Placebo comparator | Control Canned Tuna Receives: Other: Control Canned Tuna |
| Enriched Canned Tuna Variety 1 | Experimental | Enriched Canned Tuna Variety 1: Wakame fiber Receives: Other: Enriched Canned Tuna Variety 1 |
| Enriched Canned Tuna Variety 2 | Experimental | Enriched Canned Tuna Variety 2: Polyphenols Receives: Other: Enriched Canned Tuna Variety 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1, 8, 15
Secondary outcomes (8)
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
Measured: Day 1, 8, 15
Amount of food consumed in a "food ad libitum"
120 min After eating the study product
Measured: Day 1, 8, 15
Total amount of food consumed in 24h
24h Food Record Method
Measured: Day 1, 8, 15
Change from Baseline Glucose Metabolism Parameters
Concentration of Glucose
Measured: Day 1, 8, 15
Change from Baseline Lipid Metabolism Parameters
Concentration of Cholesterol, LDL-C, HDL-C, TAG
Measured: Day 1, 8, 15
Anthropometric Parameters
Weight and height will be combined to report BMI in kg/m2
Measured: Day 1, 8, 15
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.
Measured: Day 1, 8, 15
Adverse Effects
Number of participants gastrointestinal symptoms (Nausea, Diarrhea, Bloating and other disorders)
Measured: Day 1, 8, 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2019
- Study start22 Jun 2018
- Primary completion6 Jul 2018
- Study completion1 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OverweightStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto de Investigación Hospital Universitario La Paz
- Sponsor type
- University, hospital or other
- Collaborators
- Friobas Basilio S.L.
- Responsible party
- Sponsor
- Investigators
- Carmen Gómez Candela, MD, PhD, Principal investigator, La Paz University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03921580
- Sponsor's protocol ID
- 5048
- Acronym
- SACIATUN
- Status last verified
- Jun 2018
- First submitted
- 16 Apr 2019
- Last updated
- 13 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study to Evaluate the Satiating Effect of Enriched Canned Tuna With Fibre or Polyphenols in a Group of Healthy Overweight Subjects
- ClinicalTrials.gov ID
- NCT03921580
- Acronym / sponsor ID
- SACIATUN / 5048
- Conditions
- Overweight
- Keywords
- Satiety, Polyphenols, Fibre, Visual Analogue Scale, Cross-over, Tuna
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Instituto de Investigación Hospital Universitario La PazUniversity, hospital or other
- Collaborators
- Friobas Basilio S.L.
- Study start
- 22 Jun 2018 (actual)
- Primary completion
- 6 Jul 2018 (actual)
- Study completion
- 1 Sep 2018 (actual)
- First posted
- 19 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control Canned Tuna | Placebo comparator | Other: Control Canned TunaControl Canned Tuna |
| Enriched Canned Tuna Variety 1 | Experimental | Other: Enriched Canned Tuna Variety 1Enriched Canned Tuna Variety 1: Wakame fiber |
| Enriched Canned Tuna Variety 2 | Experimental | Other: Enriched Canned Tuna Variety 2Enriched Canned Tuna Variety 2: Polyphenols |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Control Canned Tuna210 g/day | Other | Control Canned Tuna |
| Enriched Canned Tuna Variety 1210 g/day | Other | Enriched Canned Tuna Variety 1 |
| Enriched Canned Tuna Variety 2210 g/day | Other | Enriched Canned Tuna Variety 2 |
Primary outcome
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.
8 secondary outcomes
Change from Baseline Blood Hormonal Satiety Markers
Time frame: Day 1, 8, 15
Amount of food consumed in a "food ad libitum"
Time frame: Day 1, 8, 15
Total amount of food consumed in 24h
Time frame: Day 1, 8, 15
Change from Baseline Glucose Metabolism Parameters
Time frame: Day 1, 8, 15
Change from Baseline Lipid Metabolism Parameters
Time frame: Day 1, 8, 15
Anthropometric Parameters
Time frame: Day 1, 8, 15
Sensory Perception Test
Time frame: Day 1, 8, 15
Adverse Effects
Time frame: Day 1, 8, 15
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carmen Gómez Candela, MD, PhD principal investigator
La Paz University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enriched Canned Tuna Variety 1 and Enriched Canned Tuna Variety 2 in people with Overweight, run by Instituto de Investigación Hospital Universitario La Paz at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline Satiety Hunger Assessment (time frame: Day 1, 8, 15). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2022.