Snack Food
Conditions
Keywords
carob, seaweed, snack food, obese subjects
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.
Interventions
OTHERActive snack food
snack enriched with seaweeds and carob
OTHERControl snack food
the same snack food without seaweeds and carob
Sponsors
Endocrinology and Clinical Nutrition Research Center, Spain
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| carbohydrate metabolism | change from baseline fasting glucose levels (mg/dl) at 8 weeks | change of seric carbohydrate parameters markers such as fasting glucose levels (mg/dl) |
| 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) |
Countries
Spain
Outcome results
None listed