Elaboration of New Generation Snacks

Endocrinology and Clinical Nutrition Research Center, Spain

Status: Completed

Conditions: Snack Food

Treatments: Other: Active snack food; Other: Control snack food

Study type: Interventional

Funder types: Other

Identifiers

NCT03420989

casve-nm-15-220

Details and patient eligibility

About

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 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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups, including a placebo group

Active snack food

Active Comparator group

Description:

snack food with carob and seaweeds 50 gr per day

Treatment:

Other: Active snack food

Control snack food

Placebo Comparator group

Description:

snack food without carob and seaweeds 50 gr per day

Treatment:

Other: Control snack food