Elaboration of New Generation Snacks

Study Overview
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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.

Official Title
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Development of a Novel Healthy Snacks Including Seaweeds and Carob Which Improve Risk Factors Associated With Metabolic Syndrome

Conditions
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Snack Food

Intervention / Treatment
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* Other: Active snack food
* Other: Control snack food


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Active snack food<br>snack food with carob and seaweeds 50 gr per day | Other: Active snack food<br>* snack enriched with seaweeds and carob<br>|
| Placebo Comparator: Control snack food<br>snack food without carob and seaweeds 50 gr per day | Other: Control snack food<br>* the same snack food without seaweeds and carob<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lipoproteins | change in serum lipoprotein levels such as HDL-cholesterol and LDL cholesterol (mg/dl) | change from baseline HDL cholesterol (mg/dl) and LDL cholesterol (mg/dl )levels at 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| carbohydrate metabolism | change of seric carbohydrate parameters markers such as fasting glucose levels (mg/dl) | change from baseline fasting glucose levels (mg/dl) at 8 weeks | 
| carbohydrate metabolism | change of seric carbohydrate parameters markers such as insulin levels (UI/L) | change from baseline insulin levels (UI/L) at 8 weeks | 
| carbohydrate metabolism | change of seric carbohydrate parameters markers such as HOMA-Insulin resistance (units) | change from baseline HOMA-Insulin Resistance (units) at 8 weeks | 
| Blood pressure | change of systolic blood pressure (mmHg) and diastolic blood pressure (mmHg) | change from baseline systolic blood pressure (mmHg) and diastolic blood pressure (mmHg) at 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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carob, seaweed, snack food, obese subjects