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

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.

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 Overview

• Status: Completed
• Conditions: Obesity, Abdominal
• Intervention / Treatment: Combination product: Placebo; Combination product: Surimi intervention

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Phase 2

Contacts and Locations

Study Locations

• Spain
  • Tarragona
    • Reus, Tarragona, Spain
      • Centro Tecnológico de Nutrición y Salud (Eurecat-Reus)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Combination product: Placebo; Conventional surimi It was a 3 months nutritional intervention. Volunteers will eat 50g per day of conventional surimi.
Experimental: Surimi intervention	Combination product: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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)	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).	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.	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).	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.	12 weeks, week 1 and week 12

Collaborators and Investigators

• Sponsor: Technological Centre of Nutrition and Health, Spain

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 2, 2018
• Primary Completion (Actual): December 23, 2018
• Study Completion (Actual): December 23, 2018

Study Registration Dates

• First Submitted: July 31, 2018
• First Submitted That Met QC Criteria: August 14, 2018
• First Posted (Actual): August 15, 2018

Study Record Updates

• Last Update Posted (Actual): March 2, 2022
• Last Update Submitted That Met QC Criteria: March 1, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: probiotics; visceral fat; abdominal obesity
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Obesity; Obesity, Abdominal
• Other Study ID Numbers: SURINORM

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No