Development of a Novel Healthy Snacks Including Seaweeds and Carob Which Improve Risk Factors Associated With Metabolic Syndrome
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Snack Food
- Sponsor
- Endocrinology and Clinical Nutrition Research Center, Spain
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Lipoproteins
- Status
- Completed
- Last Updated
- 3 years ago
Overview
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.
Investigators
Daniel de Luis Roman
Medical Doctor
Endocrinology and Clinical Nutrition Research Center, Spain
Eligibility Criteria
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
Outcomes
Primary Outcomes
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 Outcomes
- Blood pressure(change from baseline systolic blood pressure (mmHg) and diastolic blood pressure (mmHg) at 8 weeks)
- carbohydrate metabolism(change from baseline HOMA-Insulin Resistance (units) at 8 weeks)