An interventional study of Active snack food and Control snack food in Snack Food, sponsored by Endocrinology and Clinical Nutrition Research Center, Spain. Completed at 1 site in Spain. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2023-02-08.
Sponsored by Endocrinology and Clinical Nutrition Research Center, Spain · Not applicable, Interventional, and Treatment
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.
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.
Endocrinology and Clinical Nutrition Research Center, Spain is the lead sponsor of 4 studies on the registry; none are open to participants now.
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Exclusion Criteria:
snack food with carob and seaweeds 50 gr per day
Other: Active snack food
snack food without carob and seaweeds 50 gr per day
Other: Control snack food
snack enriched with seaweeds and carob
the same snack food without seaweeds and carob
Lipoproteins
change in serum lipoprotein levels such as HDL-cholesterol and LDL cholesterol (mg/dl)
Time frame: change from baseline HDL cholesterol (mg/dl) and LDL cholesterol (mg/dl )levels at 8 weeks
carbohydrate metabolism
change of seric carbohydrate parameters markers such as fasting glucose levels (mg/dl)
Time frame: change from baseline fasting glucose levels (mg/dl) at 8 weeks
carbohydrate metabolism
change of seric carbohydrate parameters markers such as insulin levels (UI/L)
Time frame: change from baseline insulin levels (UI/L) at 8 weeks
carbohydrate metabolism
change of seric carbohydrate parameters markers such as HOMA-Insulin resistance (units)
Time frame: change from baseline HOMA-Insulin Resistance (units) at 8 weeks
Blood pressure
change of systolic blood pressure (mmHg) and diastolic blood pressure (mmHg)
Time frame: change from baseline systolic blood pressure (mmHg) and diastolic blood pressure (mmHg) at 8 weeks
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.
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Endocrinology and Clinical Nutrition Research Center, Spain