Obesity, AbdominalPhase 2NCT03630588
Effect of the Consumption of an Enriched Surimi in Abdominal Visceral Adiposity
A Phase 2 study testing Surimi intervention in people with Obesity, Abdominal, run by Technological Centre of Nutrition and Health, Spain at 1 site in Spain.
Trial summary
The finding that the combination of the inactivated probiotic Bifidobacterium Lactis (BPL1), inulin as a source of soluble fiber and omega-3 fatty acids, eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), in a surimi matrix has positive effects on visceral adiposity , insulin resistance and plasma… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity, Abdominal
- What is being tested?
- Surimi intervention
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteSpain
- Study dates
- 2 Aug 2018to 23 Dec 2018
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women over 18 years of age with a waist circumference ≥102 cm in men and ≥88 cm in women.
- Sign the informed consent.
Who cannot join
- Having any condition incompatible with nuclear magnetic resonance (RNM) tests, such as metallic implants or sensitive to magnetic fields, pacemakers or suffering from claustrophobia.
- Having diabetes (glucose ≥ 126 mg / dL).
- BMI values ≥ 40 kg / m2
- Waist circumference> 150 cm.
- Present dyslipidemia (LDL cholesterol ≥ 189 mg / dL and / or triglycerides ≥ 350 mg / dL).
- Take supplements or multivitamin supplements or phytotherapeutic products that interfere with the treatment under study.
Show all 17Show fewer
- Present chronic alcoholism.
- Present some chronic gastrointestinal disease.
- Present intolerances and / or food allergies related to the study product.
- Presenting anemia (hemoglobin ≤13 g / dL in men and ≤12 g / dL in women)
- Present some chronic disease in clinical manifestation.
- Being pregnant or intending to become pregnant.
- Be in breastfeeding period.
- Participate in or have participated in a clinical trial or nutritional intervention study in the last 30 days prior to inclusion in the study.
- Follow a hypocaloric diet and / or pharmacological treatment for weight loss.
- Suffer eating disorders.
- Being unable to follow the study guidelines.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Centro Tecnológico de Nutrición y Salud (Eurecat-Reus)
Reus, Tarragona
About this study
Official title: Effect of the Consumption of an Enriched Surimi in Abdominal Visceral Adiposity. Randomized, Controlled, Parallel and Double-blind Study
The finding that the combination of the inactivated probiotic Bifidobacterium Lactis (BPL1), inulin as a source of soluble fiber and omega-3 fatty acids, eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), in a surimi matrix has positive effects on visceral adiposity , insulin resistance and plasma tryclycerides in a preclinical model of rats that present obesity induced by diet is the basis of the present hypothesis. This finding is based on the fact that these three bioactive compounds exert these effects through sensibly different and complementary mechanisms, which suggests that their combined use may have synergistic effects.
On this basis the present hypothesis is posed: the consumption of surimi enriched with inactivated probiotic BPL1, inulin and omega-3 fatty acids, in the same doses that have been effective in obese rats (SIAP), can induce a reduction of more than 5% of visceral adipose tissue, being clinically relevant in people with abdominal obesity.
Read more
If the effect on abdominal obesity is associated or not with a lower glycemia and / or absorption of fats induced by the consumption of surimi can be evaluated by monitoring these parameters for 4 hours after the ingestion of a breakfast high in fat.
The main objective of this study was to evaluate the effects of the consumption of surimi enriched with the probiotic BPL1, inulin and omega-3 fatty acids, on visceral abdominal adiposity in people with abdominal obesity.
- Conditions
- Obesity, Abdominal
- Being tested
- Surimi intervention, Placebo
- Keywords
- probiotics, visceral fat, abdominal obesity
- Medical subject headings
- Obesity, Abdominal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surimi interventionCombination product
The bioactive compounds used to obtain the surimi product are:
- Inulin (3.4 grams per 100 grams of surimi, 1.7 grams per 50 grams of surimi): Obtained from Chicory originating in Europe.
- EPA + DHA (740 mg per 100 g of surimi, therefore 370 mg per 50 g): Obtained from sardine and anchovy fish oil, encapsulated in tilapia gelatine, originating in the United States.
- Probiotic BPL1
It was a 3 months nutritional intervention. Volunteers will eat 50g per day of enriched surimi.
PlaceboCombination product
Conventional surimi
It was a 3 months nutritional intervention. Volunteers will eat 50g per day of conventional surimi.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Combination Product: Placebo |
| Surimi intervention | Experimental | Not described Receives: Combination Product: Surimi intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in abdominal visceral fat (measured in mm2)
measured by magnetic resonance imaging (MRI), transverse body scan in one axial slice 5 cm over L5-S1.
Measured: 12 weeks, week 1 and week 12
Secondary outcomes (6)
Changes in parameters of body composition (weight, measured in kg)
Trained dieticians measure weight using a body composition analyzer (Tanita SC 330-S; Tanita Corp., Barcelona, Spain).
Measured: 12 weeks, week 1 and week 12
Changes in parameters of body composition (height, measured in meters)
Trained dieticians measure height using a well mounted stadiometer (Tanita Leicester Portable; Tanita Corp., Barcelona, Spain)
Measured: 12 weeks, week 1
Changes in parameters of body composition (BMI)
Body mass index (BMI) is calculated as the ratio between measured weight (kg)/and the square of height (m).
Measured: 12 weeks, week 1 and week 12
Changes in parameters of body composition (waist circumference, measured in centimeters)
Waist circumference (WC) is measured at the umbilicus using a 150 cm anthropometric steel measuring tape.
Measured: 12 weeks, week 1 and week 12
Changes in blood pressure (measured in mmHg)
Systolic and diastolic blood pressure (SBP and DBP) are measured twice after 2-5 minutes of patient respite, seated, with one-minute interval in between, using an automatic sphygmomanometer (OMRON HEM-907; Peroxfarma, Barcelona, Spain).
Measured: 12 weeks, week 1 and week 12
Changes in plasmatic parameters (glucose, total cholesterol, LDL and HDL cholesterol, triglycerides, non-esterified fatty acids, Apo B100, Apo A1 and Insulin, measured in mg/dL)
Serum lipids and apolipoproteins, non-esterified fatty acids, glucose, and insulin concentrations are measured in serum by standardized enzymatic automated methods in an autoanalyzer (Beckman Coulter-Synchron, Galway, Ireland). LDL-c is calculated by the Friedewald formula.
Measured: 12 weeks, week 1 and week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2018
- Study start2 Aug 2018
- Primary completion23 Dec 2018
- Study completion23 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Obesity, AbdominalStudies 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Technological Centre of Nutrition and Health, Spain
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03630588
- Sponsor's protocol ID
- SURINORM
- Status last verified
- Mar 2022
- First submitted
- 31 Jul 2018
- Last updated
- 2 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Companys J, Calderon-Perez L, Pla-Paga L, Llaurado E, Sandoval-Ramirez BA, Gosalbes MJ, Arregui A, Barandiaran M, Caimari A, Del Bas JM, Arola L, Valls RM, Sola R, Pedret A. Effects of enriched seafood sticks (heat-inactivated B. animalis subsp. lactis CECT 8145, inulin, omega-3) on cardiometabolic risk factors and gut microbiota in abdominally obese subjects: randomized controlled trial. Eur J Nutr. 2022 Oct;61(7):3597-3611. doi: 10.1007/s00394-022-02904-0. Epub 2022 May 28.
PubMed 35643872
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of the Consumption of an Enriched Surimi in Abdominal Visceral Adiposity. Randomized, Controlled, Parallel and Double-blind Study
- ClinicalTrials.gov ID
- NCT03630588
- Acronym / sponsor ID
- SURINORM
- Conditions
- Obesity, Abdominal
- Keywords
- probiotics, visceral fat, abdominal obesity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Technological Centre of Nutrition and Health, SpainUniversity, hospital or other
- Study start
- 2 Aug 2018 (actual)
- Primary completion
- 23 Dec 2018 (actual)
- Study completion
- 23 Dec 2018 (actual)
- First posted
- 15 Aug 2018 (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 finding that the combination of the inactivated probiotic Bifidobacterium Lactis (BPL1), inulin as a source of soluble fiber and omega-3 fatty acids, eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), in a surimi matrix has positive effects on visceral adiposity , insulin resistance and plasma tryclycerides in a preclinical model of rats that present obesity induced by diet is the basis of the present hypothesis. This finding is based on the fact that these three bioactive compounds exert these effects through sensibly different and complementary mechanisms, which suggests that their combined use may have synergistic effects.
On this basis the present hypothesis is posed: the consumption of surimi enriched with inactivated probiotic BPL1, inulin and omega-3 fatty acids, in the same doses that have been effective in obese rats (SIAP), can induce a reduction of more than 5% of visceral adipose tissue, being clinically relevant in people with abdominal obesity.
If the effect on abdominal obesity is associated or not with a lower glycemia and / or absorption of fats induced by the consumption of surimi can be evaluated by monitoring these parameters for 4 hours after the ingestion of a breakfast high in fat.
The main objective of this study was to evaluate the effects of the consumption of surimi enriched with the probiotic BPL1, inulin and omega-3 fatty acids, on visceral abdominal adiposity in people with abdominal obesity.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Combination Product: Placebo |
| Surimi intervention | Experimental | Combination Product: Surimi intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Men and women over 18 years of age with a waist circumference ≥102 cm in men and ≥88 cm in women.
- Sign the informed consent.
Key exclusion criteria (17 listed)
- Having any condition incompatible with nuclear magnetic resonance (RNM) tests, such as metallic implants or sensitive to magnetic fields, pacemakers or suffering from claustrophobia.
- Having diabetes (glucose ≥ 126 mg / dL).
- BMI values ≥ 40 kg / m2
- Waist circumference> 150 cm.
- Present dyslipidemia (LDL cholesterol ≥ 189 mg / dL and / or triglycerides ≥ 350 mg / dL).
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 |
|---|---|---|
| Surimi interventionThe bioactive compounds used to obtain the surimi product are: * Inulin (3.4 grams per 100 grams of surimi, 1.7 grams per 50 grams of surimi): Obtained from Chicory originating in Europe. * EPA + DHA (740 mg per 100 g of surimi, therefore 370 mg per 50 g): Obtained from sardine and anchovy fish oil, encapsulated in tilapia gelatine, originating in the United States. * Probiotic BPL1 It was a 3 months nutritional intervention. Volunteers will eat 50g per day of enriched surimi. | Combination product | Surimi intervention |
| PlaceboConventional surimi It was a 3 months nutritional intervention. Volunteers will eat 50g per day of conventional surimi. | Combination product | Placebo |
Primary outcome
Changes in abdominal visceral fat (measured in mm2)
Time frame: 12 weeks, week 1 and week 12
measured by magnetic resonance imaging (MRI), transverse body scan in one axial slice 5 cm over L5-S1.
6 secondary outcomes
Changes in parameters of body composition (weight, measured in kg)
Time frame: 12 weeks, week 1 and week 12
Changes in parameters of body composition (height, measured in meters)
Time frame: 12 weeks, week 1
Changes in parameters of body composition (BMI)
Time frame: 12 weeks, week 1 and week 12
Changes in parameters of body composition (waist circumference, measured in centimeters)
Time frame: 12 weeks, week 1 and week 12
Changes in blood pressure (measured in mmHg)
Time frame: 12 weeks, week 1 and week 12
Changes in plasmatic parameters (glucose, total cholesterol, LDL and HDL cholesterol, triglycerides, non-esterified fatty acids, Apo B100, Apo A1 and Insulin, measured in mg/dL)
Time frame: 12 weeks, week 1 and week 12
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 2 Mar 2022.
- Derived from this study: PubMed 35643872Companys J, Calderon-Perez L, Pla-Paga L, Llaurado E, Sandoval-Ramirez BA, Gosalbes MJ, Arregui A, Barandiaran M, Caimari A, Del Bas JM, Arola L, Valls RM, Sola R, Pedret A. Effects of enriched seafood sticks (heat-inactivated B. animalis subsp. lactis CECT 8145, inulin, omega-3) on cardiometabolic risk factors and gut microbiota in abdominally obese subjects: randomized controlled trial. Eur J Nutr. 2022 Oct;61(7):3597-3611. doi: 10.1007/s00394-022-02904-0. Epub 2022 May 28.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Surimi intervention in people with Obesity, Abdominal, run by Technological Centre of Nutrition and Health, Spain 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 2 inclusion and 17 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 2 Mar 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Changes in abdominal visceral fat (measured in mm2) (time frame: 12 weeks, week 1 and week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03630588, which also lists 1 linked publication.
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 2 Mar 2022.