Metabolic SyndromeALGAENERGYNCT05343858
Pilot Study to Evaluate the Effect of Two Microalgae Consumption on Metabolic Syndrome
A study testing Experimental: Group 1: Spirulina platensis and Experimental: Group 2: Chlorella vulgaris in people with Metabolic Syndrome, run by Instituto de Investigación Hospital Universitario La Paz at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Metabolic Syndrome
- What is being tested?
- Experimental: Group 1: Spirulina platensis and Experimental: Group 2: Chlorella vulgaris
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteSpain
- Study dates
- 9 Sep 2019to 31 Jan 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Metabolic Syndrome
- Being tested
- Experimental: Group 1: Spirulina platensis, Experimental: Group 2: Chlorella vulgaris, Placebo Comparator: Group 3: Control
- Keywords
- microalgae, lipid profile, metabolic syndrome, pilot
- Medical subject headings
- Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental: Group 1: Spirulina platensisDietary supplement
16 g/day (two doses of 8g)
Experimental: Group 2: Chlorella vulgarisDietary supplement
16 g/day (two doses of 8g)
Placebo Comparator: Group 3: ControlDietary supplement
16 g/day (two doses of 8g)
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Spirulina platensis | Experimental | 10 volunteers will consume 16g / day (in 2 doses of 8g) of a nutritional supplement of Spirulina platensis Receives: 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 Receives: 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 Receives: Dietary Supplement: Placebo Comparator: Group 3: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum cholesterol
Biomarker of metabolic syndrome
Measured: Change from baseline at 30 days
Serum HDL
Biomarker of lipid profile quality
Measured: Change from baseline at 30 days
Serum LDL syndrome biomarker
Biomarker of lipid profile quality
Measured: Change from baseline at 30 days
Triglycerides (TAG)
Biomarker of lipid profile quality
Measured: Change from baseline at 30 days
Apolipoprotein A
Metabolic syndrome biomarker
Measured: Change from baseline at 30 days
Apolipoprotein B
Metabolic syndrome biomarker
Measured: Change from baseline at 30 days
Secondary outcomes (12)
Blood count
Concentration of blood
Measured: Change from baseline at 30 days
Body weight
Changes on anthropometric characteristics
Measured: Change from baseline at 30 days
Tolerance
Occurrence and frequency of gastrointestinal symptoms
Measured: Change from baseline at 30 days
Body Mass Index
Changes on anthropometric characteristics
Measured: Change from baseline at 30 days
Waist circumference
Changes on anthropometric characteristics
Measured: Change from baseline at 30 days
Adherence
Changes in the number of consumed pills
Measured: Change from baseline at 30 days
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
Measured: Change from baseline at 30 days
Dietary intake
Changes in diet composition through 24-hour dietary record
Measured: Change from baseline at 30 days
Glucose
Concentration of glucose
Measured: Change from baseline at 30 days
Urate
Concentration of safety marker
Measured: Change from baseline at 30 days
Creatinine
Concentration of creatinine
Measured: Change from baseline at 30 days
Calcium
Concentration of minerals
Measured: Change from baseline at 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2022
- Study start9 Sep 2019
- Primary completion9 Oct 2019
- Study completion31 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto de Investigación Hospital Universitario La Paz
- Sponsor type
- University, hospital or other
- Collaborators
- AlgaEnergy, S.A.
- Responsible party
- Sponsor
- Investigators
- Carmen Gómez-Candela, Principal investigator, La Paz University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05343858
- Sponsor's protocol ID
- HULP 5296
- Acronym
- ALGAENERGY
- Status last verified
- Sep 2019
- First submitted
- 6 Sep 2019
- Last updated
- 11 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05343858
- Acronym / sponsor ID
- ALGAENERGY / HULP 5296
- Conditions
- Metabolic Syndrome
- Keywords
- microalgae, lipid profile, metabolic syndrome, pilot
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Instituto de Investigación Hospital Universitario La PazUniversity, hospital or other
- Collaborators
- AlgaEnergy, S.A.
- Study start
- 9 Sep 2019 (actual)
- Primary completion
- 9 Oct 2019 (actual)
- Study completion
- 31 Jan 2021 (actual)
- First posted
- 25 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1: Spirulina platensis | Experimental | Dietary Supplement: Experimental: Group 1: Spirulina platensis10 volunteers will consume 16g / day (in 2 doses of 8g) of a nutritional supplement of Spirulina platensis |
| Group 2: Chlorella vulgaris | Experimental | Dietary Supplement: Experimental: Group 2: Chlorella vulgaris10 volunteers will consume 16g / day (in 2 doses of 8g) of a nutritional supplement of Chlorella vulgaris |
| Group 3: Control | Placebo comparator | Dietary Supplement: Placebo Comparator: Group 3: Control10 volunteers will consume 16g / day (in 2 doses of 8g) of a control supplement |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experimental: Group 1: Spirulina platensis16 g/day (two doses of 8g) | Dietary supplement | Group 1: Spirulina platensis |
| Experimental: Group 2: Chlorella vulgaris16 g/day (two doses of 8g) | Dietary supplement | Group 2: Chlorella vulgaris |
| Placebo Comparator: Group 3: Control16 g/day (two doses of 8g) | Dietary supplement | Group 3: Control |
Primary outcome
Serum cholesterol
Time frame: Change from baseline at 30 days
Biomarker of metabolic syndrome
Serum HDL
Time frame: Change from baseline at 30 days
Biomarker of lipid profile quality
Serum LDL syndrome biomarker
Time frame: Change from baseline at 30 days
Biomarker of lipid profile quality
Triglycerides (TAG)
Time frame: Change from baseline at 30 days
Biomarker of lipid profile quality
Apolipoprotein A
Time frame: Change from baseline at 30 days
Metabolic syndrome biomarker
Apolipoprotein B
Time frame: Change from baseline at 30 days
Metabolic syndrome biomarker
12 secondary outcomes
Blood count
Time frame: Change from baseline at 30 days
Body weight
Time frame: Change from baseline at 30 days
Tolerance
Time frame: Change from baseline at 30 days
Body Mass Index
Time frame: Change from baseline at 30 days
Waist circumference
Time frame: Change from baseline at 30 days
Adherence
Time frame: Change from baseline at 30 days
Sensory perception Visual Analog Scale (VAS) rate from 1 to 100 related with flavor, aro
Time frame: Change from baseline at 30 days
Dietary intake
Time frame: Change from baseline at 30 days
Glucose
Time frame: Change from baseline at 30 days
Urate
Time frame: Change from baseline at 30 days
Creatinine
Time frame: Change from baseline at 30 days
Calcium
Time frame: Change from baseline at 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carmen Gómez-Candela principal investigator
La Paz University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental: Group 1: Spirulina platensis and Experimental: Group 2: Chlorella vulgaris in people with Metabolic Syndrome, run by Instituto de Investigación Hospital Universitario La Paz at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum cholesterol (time frame: Change from baseline at 30 days). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2022.