Elaboration of New Generation Snacks

Overview

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.

Full Title of Study: “Development of a Novel Healthy Snacks Including Seaweeds and Carob Which Improve Risk Factors Associated With Metabolic Syndrome”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: September 18, 2019

Detailed Description

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.

Interventions

  • Other: Active snack food
    • snack enriched with seaweeds and carob
  • Other: Control snack food
    • the same snack food without seaweeds and carob

Arms, Groups and Cohorts

  • Active Comparator: Active snack food
    • snack food with carob and seaweeds 50 gr per day
  • Placebo Comparator: Control snack food
    • snack food without carob and seaweeds 50 gr per day

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Endocrinology and Clinical Nutrition Research Center, Spain
  • Provider of Information About this Clinical Study
    • Principal Investigator: Daniel de Luis Roman, Medical Doctor – Endocrinology and Clinical Nutrition Research Center, Spain

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