Elaboration of New Generation Snacks

Not Applicable

Completed

• Conditions: Snack Food
• Interventions: Other: Control snack food; Other: Active snack food

• Registration Number: NCT03420989
• Lead Sponsor: Endocrinology and Clinical Nutrition Research Center, Spain

Brief Summary

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

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 Timeline

• Study First Submitted: 2016-12-17
• Study Start: 2018-01-18
• Study First Submitted QC: 2018-02-01
• Study First Posted: 2018-02-05
• Primary Completion: 2019-09-18
• Study Completion: 2019-12-18
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-06
• Last Update Posted: 2023-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control snack food	Control snack food	snack food without carob and seaweeds 50 gr per day
Active snack food	Active snack food	snack food with carob and seaweeds 50 gr per day

Primary Outcome Measures

Name	Time	Method
Lipoproteins	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 Outcome Measures

Name	Time	Method
Blood pressure	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)
carbohydrate metabolism	change from baseline HOMA-Insulin Resistance (units) at 8 weeks	change of seric carbohydrate parameters markers such as HOMA-Insulin resistance (units)

Trial Locations

Locations (1)

Daniel de Luis Roman; 🇪🇸 Valladolid, Spain