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OpenTrials
Completed

NCT Number: NCT03420989

Elaboration of New Generation Snacks

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.

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Key information

Conditions

Snack Food

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Daniel de Luis Roman

Valladolid, 47003, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Active snack food

Other

snack enriched with seaweeds and carob

Control snack food

Other

the same snack food without seaweeds and carob

Primary outcomes

  1. 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

  1. carbohydrate metabolism

    Time frame: change from baseline fasting glucose levels (mg/dl) at 8 weeks

    change of seric carbohydrate parameters markers such as fasting glucose levels (mg/dl)

  2. carbohydrate metabolism

    Time frame: change from baseline insulin levels (UI/L) at 8 weeks

    change of seric carbohydrate parameters markers such as insulin levels (UI/L)

  3. carbohydrate metabolism

    Time frame: change from baseline HOMA-Insulin Resistance (units) at 8 weeks

    change of seric carbohydrate parameters markers such as HOMA-Insulin resistance (units)

  4. Blood pressure

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Endocrinology and Clinical Nutrition Research Center, Spain

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Feb 5, 2018
Registry last updated
Feb 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.