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

NCT03630588 | Completed Phase 2

• 1 other identifier: SURINORM
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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

Keywords

probiotics; visceral fat; abdominal obesity

Outcome Measures

Primary Outcomes (1)

• 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.

  12 weeks, week 1 and week 12

Secondary Outcomes (6)

• Changes in parameters of body composition (weight, measured in kg)

  12 weeks, week 1 and week 12

• Changes in parameters of body composition (height, measured in meters)

  12 weeks, week 1

• Changes in parameters of body composition (BMI)

  12 weeks, week 1 and week 12

• Changes in parameters of body composition (waist circumference, measured in centimeters)

  12 weeks, week 1 and week 12

• Changes in blood pressure (measured in mmHg)

  12 weeks, week 1 and week 12

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Combination Product: Placebo

Surimi intervention

EXPERIMENTAL

Combination Product: Surimi intervention

Interventions

Surimi intervention 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.

Surimi intervention

Placebo COMBINATION_PRODUCT

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

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.
• Follow a hypocaloric diet and / or pharmacological treatment for weight loss.
• Suffer eating disorders.

Sponsors & Collaborators

• Technological Centre of Nutrition and Health, Spain: lead

Study Sites (1)

Centro Tecnológico de Nutrición y Salud (Eurecat-Reus)

Reus, Tarragona, Spain

Location

Related Publications (1)

• 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.

  PMID: 35643872 DERIVED

MeSH Terms

Conditions

Obesity, Abdominal

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2018
• First Posted: August 15, 2018
• Study Start: August 2, 2018
• Primary Completion: December 23, 2018
• Study Completion: December 23, 2018
• Last Updated: March 2, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)