NCT03420989

Elaboration of New Generation Snacks

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Endocrinology and Clinical Nutrition Research Center, Spain · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Snack Food

Interventions

Type	Name	Description
OTHER	Active snack food	snack enriched with seaweeds and carob
OTHER	Control snack food	the same snack food without seaweeds and carob

Timeline

• Start date: 2018-01-18
• Primary completion: 2019-09-18
• Completion: 2019-12-18
• First posted: 2018-02-05
• Last updated: 2023-02-08

Locations

1 site across 1 country: Spain