NCT05343858

Brief Summary

The purpose of this study is to evaluate the effect of the consumption of two microalgae Chlorella vulgaris and Arthrospira platensis (Spirulina) on some biomarkers of metabolic syndrome: Total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides, Apolipoprotein A and Apolipoprotein B, in overweight / obese subjects with altered lipid profile.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2019

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

September 6, 2019

Completed
3 days until next milestone

Study Start

First participant enrolled

September 9, 2019

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 9, 2019

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2021

Completed
1.2 years until next milestone

First Posted

Study publicly available on registry

April 25, 2022

Completed
Last Updated

May 11, 2022

Status Verified

September 1, 2019

Enrollment Period

1 month

First QC Date

September 6, 2019

Last Update Submit

May 5, 2022

Conditions

Metabolic Syndrome

Keywords

microalgaelipid profilemetabolic syndromepilot

Outcome Measures

Primary Outcomes (6)

  • Serum cholesterol

    Biomarker of metabolic syndrome

    Change from baseline at 30 days

  • Serum HDL

    Biomarker of lipid profile quality

    Change from baseline at 30 days

  • Serum LDL syndrome biomarker

    Biomarker of lipid profile quality

    Change from baseline at 30 days

  • Triglycerides (TAG)

    Biomarker of lipid profile quality

    Change from baseline at 30 days

  • Apolipoprotein A

    Metabolic syndrome biomarker

    Change from baseline at 30 days

  • Apolipoprotein B

    Metabolic syndrome biomarker

    Change from baseline at 30 days

Secondary Outcomes (12)

  • Blood count

    Change from baseline at 30 days

  • Body weight

    Change from baseline at 30 days

  • Tolerance

    Change from baseline at 30 days

  • Body Mass Index

    Change from baseline at 30 days

  • Waist circumference

    Change from baseline at 30 days

  • +7 more secondary outcomes

Study Arms (3)

Group 1: Spirulina platensis

EXPERIMENTAL

10 volunteers will consume 16g / day (in 2 doses of 8g) of a nutritional supplement of Spirulina platensis

Dietary Supplement: Experimental: Group 1: Spirulina platensis

Group 2: Chlorella vulgaris

EXPERIMENTAL

10 volunteers will consume 16g / day (in 2 doses of 8g) of a nutritional supplement of Chlorella vulgaris

Dietary Supplement: Experimental: Group 2: Chlorella vulgaris

Group 3: Control

PLACEBO COMPARATOR

10 volunteers will consume 16g / day (in 2 doses of 8g) of a control supplement

Dietary Supplement: Placebo Comparator: Group 3: Control

Interventions

Experimental: Group 1: Spirulina platensisDIETARY_SUPPLEMENT

16 g/day (two doses of 8g)

Group 1: Spirulina platensis
Experimental: Group 2: Chlorella vulgarisDIETARY_SUPPLEMENT

16 g/day (two doses of 8g)

Group 2: Chlorella vulgaris
Placebo Comparator: Group 3: ControlDIETARY_SUPPLEMENT

16 g/day (two doses of 8g)

Group 3: Control

Eligibility Criteria

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

You may qualify if:

  • Men and women from 18 to 65 years old.
  • Body Mass Index (BMI) ≥25 and \<40 kg/m2.
  • Cardiovascular risk \<10%
  • Adequate cultural level and understanding
  • Agree to participate in the study

You may not qualify if:

  • Subjects with BMI ≥40 or \<25 kg /m2
  • Subjects diagnosed with Diabetes Mellitus.
  • Subjects with dyslipidemia on pharmacological treatment
  • Subjects with hypertension on pharmacological treatment
  • Subjects with established diagnosis of eating disorder
  • Smokers or those subjects with high alcohol consumption
  • Subjects under pharmacological treatment
  • Subjects with large weight fluctuations of more than 4 kg or who have undergone in six months a weight loss diet
  • Subjects with sensory problems
  • Subjects with gastrointestinal diseases that affect the digestion or absorption of nutrients
  • Pregnant or breastfeeding women
  • Women with menstrual irregularities
  • Subjects with intense physical activity
  • Subjects with food allergies to meals included in breakfast, study product or lunch or that reject their consumption
  • Subjects with a diagnosis of celiac disease or a gluten intolerance

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute for Health Research IdiPAZ

Madrid, 28046, Spain

Location

MeSH Terms

Conditions

Metabolic Syndrome

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Carmen Gómez-Candela

    La Paz University Hospital

    PRINCIPAL INVESTIGATOR

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
SPONSOR

Study Record Dates

First Submitted

September 6, 2019

First Posted

April 25, 2022

Study Start

September 9, 2019

Primary Completion

October 9, 2019

Study Completion

January 31, 2021

Last Updated

May 11, 2022

Record last verified: 2019-09

Locations

ES(1)