NCT03420989

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 17, 2016

Completed
1.1 years until next milestone

Study Start

First participant enrolled

January 18, 2018

Completed
18 days until next milestone

First Posted

Study publicly available on registry

February 5, 2018

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 18, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 18, 2019

Completed
Last Updated

February 8, 2023

Status Verified

February 1, 2023

Enrollment Period

1.7 years

First QC Date

December 17, 2016

Last Update Submit

February 6, 2023

Conditions

Snack Food

Keywords

carobseaweedsnack foodobese subjects

Outcome Measures

Primary Outcomes (1)

  • Lipoproteins

    change in serum lipoprotein levels such as HDL-cholesterol and LDL cholesterol (mg/dl)

    change from baseline HDL cholesterol (mg/dl) and LDL cholesterol (mg/dl )levels at 8 weeks

Secondary Outcomes (4)

  • carbohydrate metabolism

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

  • carbohydrate metabolism

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

  • carbohydrate metabolism

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

  • Blood pressure

    change from baseline systolic blood pressure (mmHg) and diastolic blood pressure (mmHg) at 8 weeks

Study Arms (2)

Active snack food

ACTIVE COMPARATOR

snack food with carob and seaweeds 50 gr per day

Other: Active snack food

Control snack food

PLACEBO COMPARATOR

snack food without carob and seaweeds 50 gr per day

Other: Control snack food

Interventions

Active snack foodOTHER

snack enriched with seaweeds and carob

Active snack food
Control snack foodOTHER

the same snack food without seaweeds and carob

Control snack food

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • presence of metabolic syndrome by (Adult Treatment Panel III) criteria

You may not qualify if:

  • consume supplements (vitamins, minerals or other dietary components),
  • non-restrictive diet
  • known chronic disease (eg diabetes, cardiovascular disease, Inflammatory diseases).
  • active cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Daniel de Luis Roman

Valladolid, 47003, Spain

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor

Study Record Dates

First Submitted

December 17, 2016

First Posted

February 5, 2018

Study Start

January 18, 2018

Primary Completion

September 18, 2019

Study Completion

December 18, 2019

Last Updated

February 8, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)