Effect of the Consumption of an Enriched Surimi in Abdominal Visceral Adiposity

NCT ID: NCT03630588

Last Updated: 2022-03-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-02
• Study Completion Date: 2018-12-23

Brief 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 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.

Conditions

Obesity, Abdominal

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: COMBINATION_PRODUCT

Conventional surimi

It was a 3 months nutritional intervention. Volunteers will eat 50g per day of conventional surimi.

Surimi intervention

Group Type: EXPERIMENTAL

Surimi intervention

Intervention Type: COMBINATION_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.

Interventions

Surimi intervention

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.

Intervention Type: COMBINATION_PRODUCT

Placebo

Conventional surimi

It was a 3 months nutritional intervention. Volunteers will eat 50g per day of conventional surimi.

Intervention Type: COMBINATION_PRODUCT

Eligibility Criteria

Inclusion Criteria

1. Men and women over 18 years of age with a waist circumference ≥102 cm in men and ≥88 cm in women.

2. Sign the informed consent.

Exclusion Criteria

1. Having any condition incompatible with nuclear magnetic resonance (RNM) tests, such as metallic implants or sensitive to magnetic fields, pacemakers or suffering from claustrophobia.

2. Having diabetes (glucose ≥ 126 mg / dL).

3. BMI values ≥ 40 kg / m2

4. Waist circumference> 150 cm.

5. Present dyslipidemia (LDL cholesterol ≥ 189 mg / dL and / or triglycerides ≥ 350 mg / dL).

6. Take supplements or multivitamin supplements or phytotherapeutic products that interfere with the treatment under study.

7. Present chronic alcoholism.

8. Present some chronic gastrointestinal disease.

9. Present intolerances and / or food allergies related to the study product.

10. Presenting anemia (hemoglobin ≤13 g / dL in men and ≤12 g / dL in women)

11. Present some chronic disease in clinical manifestation.

12. Being pregnant or intending to become pregnant.

13. Be in breastfeeding period.

14. Participate in or have participated in a clinical trial or nutritional intervention study in the last 30 days prior to inclusion in the study.

15. Follow a hypocaloric diet and / or pharmacological treatment for weight loss.

16. Suffer eating disorders.

17. Being unable to follow the study guidelines.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Technological Centre of Nutrition and Health, Spain

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Centro Tecnológico de Nutrición y Salud (Eurecat-Reus)

Reus, Tarragona, Spain

Countries

Spain

References

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.

Reference Type: DERIVED

PMID: 35643872 (View on PubMed)

Other Identifiers

SURINORM

Identifier Type: -

Identifier Source: org_study_id