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

Primary Purpose

Obesity, Abdominal

Status
Completed
Phase
Phase 2
Locations
Spain
Study Type
Interventional
Intervention
Surimi intervention
Placebo
Sponsored by
Technological Centre of Nutrition and Health, Spain
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Obesity, Abdominal focused on measuring probiotics, visceral fat, abdominal obesity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Surimi intervention

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).
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)
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).
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.
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).
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.

Full Information

First Posted
July 31, 2018
Last Updated
March 1, 2022
Sponsor
Technological Centre of Nutrition and Health, Spain
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1. Study Identification

Unique Protocol Identification Number
NCT03630588
Brief Title
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

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
August 2, 2018 (Actual)
Primary Completion Date
December 23, 2018 (Actual)
Study Completion Date
December 23, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Technological Centre of Nutrition and Health, Spain

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Abdominal
Keywords
probiotics, visceral fat, abdominal obesity

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
Surimi intervention
Arm Type
Experimental
Intervention Type
Combination Product
Intervention Name(s)
Surimi intervention
Intervention Description
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
Intervention Name(s)
Placebo
Intervention Description
Conventional surimi It was a 3 months nutritional intervention. Volunteers will eat 50g per day of conventional surimi.
Primary Outcome Measure Information:
Title
Changes in abdominal visceral fat (measured in mm2)
Description
measured by magnetic resonance imaging (MRI), transverse body scan in one axial slice 5 cm over L5-S1.
Time Frame
12 weeks, week 1 and week 12
Secondary Outcome Measure Information:
Title
Changes in parameters of body composition (weight, measured in kg)
Description
Trained dieticians measure weight using a body composition analyzer (Tanita SC 330-S; Tanita Corp., Barcelona, Spain).
Time Frame
12 weeks, week 1 and week 12
Title
Changes in parameters of body composition (height, measured in meters)
Description
Trained dieticians measure height using a well mounted stadiometer (Tanita Leicester Portable; Tanita Corp., Barcelona, Spain)
Time Frame
12 weeks, week 1
Title
Changes in parameters of body composition (BMI)
Description
Body mass index (BMI) is calculated as the ratio between measured weight (kg)/and the square of height (m).
Time Frame
12 weeks, week 1 and week 12
Title
Changes in parameters of body composition (waist circumference, measured in centimeters)
Description
Waist circumference (WC) is measured at the umbilicus using a 150 cm anthropometric steel measuring tape.
Time Frame
12 weeks, week 1 and week 12
Title
Changes in blood pressure (measured in mmHg)
Description
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).
Time Frame
12 weeks, week 1 and week 12
Title
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)
Description
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.
Time Frame
12 weeks, week 1 and week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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. 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.
Facility Information:
Facility Name
Centro Tecnológico de Nutrición y Salud (Eurecat-Reus)
City
Reus
State/Province
Tarragona
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35643872
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.
Results Reference
derived

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

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