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Pilot Study to Evaluate the Effect of Two Microalgae Consumption on Metabolic Syndrome (ALGAENERGY)

Primary Purpose

Metabolic Syndrome

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Experimental: Group 1: Spirulina platensis
Experimental: Group 2: Chlorella vulgaris
Placebo Comparator: Group 3: Control
Sponsored by
Instituto de Investigación Hospital Universitario La Paz
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metabolic Syndrome focused on measuring microalgae, lipid profile, metabolic syndrome, pilot

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • Institute for Health Research IdiPAZ

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Group 1: Spirulina platensis

Group 2: Chlorella vulgaris

Group 3: Control

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Serum cholesterol
Biomarker of metabolic syndrome
Serum HDL
Biomarker of lipid profile quality
Serum LDL syndrome biomarker
Biomarker of lipid profile quality
Triglycerides (TAG)
Biomarker of lipid profile quality
Apolipoprotein A
Metabolic syndrome biomarker
Apolipoprotein B
Metabolic syndrome biomarker

Secondary Outcome Measures

Blood count
Concentration of blood
Body weight
Changes on anthropometric characteristics
Tolerance
Occurrence and frequency of gastrointestinal symptoms
Body Mass Index
Changes on anthropometric characteristics
Waist circumference
Changes on anthropometric characteristics
Adherence
Changes in the number of consumed pills
Sensory perception Visual Analog Scale (VAS) rate from 1 to 100 related with flavor, aro
Visual Analog Scales (VAS) with a range between 0 (negative score) and 10 (positive score) related to taste, smell, texture, satiety and fullness
Dietary intake
Changes in diet composition through 24-hour dietary record
Glucose
Concentration of glucose
Urate
Concentration of safety marker
Creatinine
Concentration of creatinine
Calcium
Concentration of minerals

Full Information

First Posted
September 6, 2019
Last Updated
May 5, 2022
Sponsor
Instituto de Investigación Hospital Universitario La Paz
Collaborators
AlgaEnergy, S.A.
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1. Study Identification

Unique Protocol Identification Number
NCT05343858
Brief Title
Pilot Study to Evaluate the Effect of Two Microalgae Consumption on Metabolic Syndrome
Acronym
ALGAENERGY
Official Title
Pilot Study to Evaluate the Effect of the Consumption of Two Unicellular Microalgae (Chlorella Vulgaris and Arthrospira Platensis (Spirulina)) on Metabolic Syndrome Biomarkers in Overweight / Obese Subjects With Altered Lipid Profile
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
September 9, 2019 (Actual)
Primary Completion Date
October 9, 2019 (Actual)
Study Completion Date
January 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Instituto de Investigación Hospital Universitario La Paz
Collaborators
AlgaEnergy, S.A.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
A randomized, parallel, and double-blind pilot study with 3 study arms is being performed to evaluate the effect of the consumption of two unicellular microalgae: Chlorella vulgaris and Arthrospira platensis (Spirulina). The investigators included 30 participants between 18 and 65 years (BMI ≥25 and <40 kg / m2). All volunteers will be randomized into 3 study groups, and participants will receive the 3 different study products during 30 days.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome
Keywords
microalgae, lipid profile, metabolic syndrome, pilot

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1: Spirulina platensis
Arm Type
Experimental
Arm Description
10 volunteers will consume 16g / day (in 2 doses of 8g) of a nutritional supplement of Spirulina platensis
Arm Title
Group 2: Chlorella vulgaris
Arm Type
Experimental
Arm Description
10 volunteers will consume 16g / day (in 2 doses of 8g) of a nutritional supplement of Chlorella vulgaris
Arm Title
Group 3: Control
Arm Type
Placebo Comparator
Arm Description
10 volunteers will consume 16g / day (in 2 doses of 8g) of a control supplement
Intervention Type
Dietary Supplement
Intervention Name(s)
Experimental: Group 1: Spirulina platensis
Intervention Description
16 g/day (two doses of 8g)
Intervention Type
Dietary Supplement
Intervention Name(s)
Experimental: Group 2: Chlorella vulgaris
Intervention Description
16 g/day (two doses of 8g)
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo Comparator: Group 3: Control
Intervention Description
16 g/day (two doses of 8g)
Primary Outcome Measure Information:
Title
Serum cholesterol
Description
Biomarker of metabolic syndrome
Time Frame
Change from baseline at 30 days
Title
Serum HDL
Description
Biomarker of lipid profile quality
Time Frame
Change from baseline at 30 days
Title
Serum LDL syndrome biomarker
Description
Biomarker of lipid profile quality
Time Frame
Change from baseline at 30 days
Title
Triglycerides (TAG)
Description
Biomarker of lipid profile quality
Time Frame
Change from baseline at 30 days
Title
Apolipoprotein A
Description
Metabolic syndrome biomarker
Time Frame
Change from baseline at 30 days
Title
Apolipoprotein B
Description
Metabolic syndrome biomarker
Time Frame
Change from baseline at 30 days
Secondary Outcome Measure Information:
Title
Blood count
Description
Concentration of blood
Time Frame
Change from baseline at 30 days
Title
Body weight
Description
Changes on anthropometric characteristics
Time Frame
Change from baseline at 30 days
Title
Tolerance
Description
Occurrence and frequency of gastrointestinal symptoms
Time Frame
Change from baseline at 30 days
Title
Body Mass Index
Description
Changes on anthropometric characteristics
Time Frame
Change from baseline at 30 days
Title
Waist circumference
Description
Changes on anthropometric characteristics
Time Frame
Change from baseline at 30 days
Title
Adherence
Description
Changes in the number of consumed pills
Time Frame
Change from baseline at 30 days
Title
Sensory perception Visual Analog Scale (VAS) rate from 1 to 100 related with flavor, aro
Description
Visual Analog Scales (VAS) with a range between 0 (negative score) and 10 (positive score) related to taste, smell, texture, satiety and fullness
Time Frame
Change from baseline at 30 days
Title
Dietary intake
Description
Changes in diet composition through 24-hour dietary record
Time Frame
Change from baseline at 30 days
Title
Glucose
Description
Concentration of glucose
Time Frame
Change from baseline at 30 days
Title
Urate
Description
Concentration of safety marker
Time Frame
Change from baseline at 30 days
Title
Creatinine
Description
Concentration of creatinine
Time Frame
Change from baseline at 30 days
Title
Calcium
Description
Concentration of minerals
Time Frame
Change from baseline at 30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carmen Gómez-Candela
Organizational Affiliation
La Paz University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute for Health Research IdiPAZ
City
Madrid
ZIP/Postal Code
28046
Country
Spain

12. IPD Sharing Statement

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Pilot Study to Evaluate the Effect of Two Microalgae Consumption on Metabolic Syndrome

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