Elaboration of New Generation Snacks

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

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.

Study Overview

• Status: Completed
• Conditions: Snack Food
• Intervention / Treatment: Other: Active snack food; Other: Control snack food

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Valladolid, Spain, 47003
    • Daniel de Luis Roman

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Active snack food; snack food with carob and seaweeds 50 gr per day	Other: Active snack food; snack enriched with seaweeds and carob
PLACEBO_COMPARATOR: Control snack food; snack food without carob and seaweeds 50 gr per day	Other: Control snack food; the same snack food without seaweeds and carob

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Endocrinology and Clinical Nutrition Research Center, Spain

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 18, 2018
• Primary Completion (ACTUAL): September 18, 2019
• Study Completion (ACTUAL): December 18, 2019

Study Registration Dates

• First Submitted: December 17, 2016
• First Submitted That Met QC Criteria: February 1, 2018
• First Posted (ACTUAL): February 5, 2018

Study Record Updates

• Last Update Posted (ACTUAL): February 8, 2023
• Last Update Submitted That Met QC Criteria: February 6, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: seaweed; carob; snack food; obese subjects
• Other Study ID Numbers: casve-nm-15-220

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No