Clinical trial NCT03630588: Effect of the Consumption of an Enriched Surimi in Abdominal Visceral Adiposity
Official title: Effect of the Consumption of an Enriched Surimi in Abdominal Visceral Adiposity. Randomized, Controlled, Parallel and Double-blind Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Obesity, Abdominal
Keywords: probiotics
visceral fat
abdominal obesity
Lead sponsor: Technological Centre of Nutrition and Health, Spain
Sponsor class: OTHER
First posted: 2018-08-15
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
measure: Changes in abdominal visceral fat (measured in mm2)
timeFrame: 12 weeks, week 1 and week 12
Secondary outcomes:
measure: Changes in parameters of body composition (weight, measured in kg)
timeFrame: 12 weeks, week 1 and week 12
measure: Changes in parameters of body composition (height, measured in meters)
timeFrame: 12 weeks, week 1
measure: Changes in parameters of body composition (BMI)
timeFrame: 12 weeks, week 1 and week 12
measure: Changes in parameters of body composition (waist circumference, measured in centimeters)
timeFrame: 12 weeks, week 1 and week 12
measure: Changes in blood pressure (measured in mmHg)
timeFrame: 12 weeks, week 1 and week 12
measure: 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)
timeFrame: 12 weeks, week 1 and week 12
Other outcomes:
Locations:
city: Reus
country: Spain
facility: Centro Tecnológico de Nutrición y Salud (Eurecat-Reus)
state: Tarragona
Study officials:
References:
citation: 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.