Elaboration of New Generation Snacks

NCT ID: NCT03420989

Last Updated: 2023-02-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-18

Study Completion Date

2019-12-18

Brief Summary

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It is a blind randomized clinical trial of nutritional intervention in humans with a snack (seaweeds and carob), compared to a control snack without the bioactive ingredients studied but of similar nutritional composition, to evaluate the effect on the lipid profile, glycemia and Insulin resistance.

Detailed Description

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The design will consist of a double-blind randomized study in adult subjects with metabolic syndrome, who will consume snack (enriched in seaweeds and carob) (50 g / day) vs. conventional snack for 8 weeks.

All the next parameters will be measured/calculated at basal time and after 8 weeks of intervention. The next biochemical parameters will be measured: Total cholesterol, LDL cholesterol, HDL, triglycerides will be analyzed using an enzyme-colorimetric method (Roche Diagnostics , Mannheim, Germany). Glucose will be determined by the method of glucose oxidase (Glucose analyzer 2, Beckman Instruments, Fullerton, California), insulin will be determined by Elisa (ELISA Diagnostic Corporation, Los Angeles, CA) and HOMA will be calculated by the formula Matthew et al. , 1985 (HOMA = (glucose \* insulin) / 22.5). Body weight and fat mass by bioimpedance will be measured, too. Blood pressure (Systolic and diastolic blood pressure) will be measured, too. A diet records for 3 days and a satiety scale will be performed at the beginning and end of the intervention period.

Conditions

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Snack Food

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Active snack food

snack food with carob and seaweeds 50 gr per day

Group Type ACTIVE_COMPARATOR

Active snack food

Intervention Type OTHER

snack enriched with seaweeds and carob

Control snack food

snack food without carob and seaweeds 50 gr per day

Group Type PLACEBO_COMPARATOR

Control snack food

Intervention Type OTHER

the same snack food without seaweeds and carob

Interventions

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Active snack food

snack enriched with seaweeds and carob

Intervention Type OTHER

Control snack food

the same snack food without seaweeds and carob

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* presence of metabolic syndrome by (Adult Treatment Panel III) criteria

Exclusion Criteria

* consume supplements (vitamins, minerals or other dietary components),
* non-restrictive diet
* known chronic disease (eg diabetes, cardiovascular disease, Inflammatory diseases).
* active cancer
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Endocrinology and Clinical Nutrition Research Center, Spain

OTHER

Sponsor Role lead

Responsible Party

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Daniel de Luis Roman

Medical Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Daniel de Luis Roman

Valladolid, , Spain

Site Status

Countries

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Spain

Other Identifiers

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casve-nm-15-220

Identifier Type: -

Identifier Source: org_study_id

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