Clinical trial NCT05343858: Pilot Study to Evaluate the Effect of Two Microalgae Consumption on Metabolic Syndrome
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
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic Syndrome
Keywords: microalgae
lipid profile
metabolic syndrome
pilot
Lead sponsor: Instituto de Investigación Hospital Universitario La Paz
Sponsor class: OTHER
Collaborators: name: AlgaEnergy, S.A.
First posted: 2022-04-25
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Serum cholesterol
timeFrame: Change from baseline at 30 days
measure: Serum HDL
timeFrame: Change from baseline at 30 days
measure: Serum LDL syndrome biomarker
timeFrame: Change from baseline at 30 days
measure: Triglycerides (TAG)
timeFrame: Change from baseline at 30 days
measure: Apolipoprotein A
timeFrame: Change from baseline at 30 days
measure: Apolipoprotein B
timeFrame: Change from baseline at 30 days
Secondary outcomes:
measure: Blood count
timeFrame: Change from baseline at 30 days
measure: Body weight
timeFrame: Change from baseline at 30 days
measure: Tolerance
timeFrame: Change from baseline at 30 days
measure: Body Mass Index
timeFrame: Change from baseline at 30 days
measure: Waist circumference
timeFrame: Change from baseline at 30 days
measure: Adherence
timeFrame: Change from baseline at 30 days
measure: Sensory perception Visual Analog Scale (VAS) rate from 1 to 100 related with flavor, aro
timeFrame: Change from baseline at 30 days
measure: Dietary intake
timeFrame: Change from baseline at 30 days
measure: Glucose
timeFrame: Change from baseline at 30 days
measure: Urate
timeFrame: Change from baseline at 30 days
measure: Creatinine
timeFrame: Change from baseline at 30 days
measure: Calcium
timeFrame: Change from baseline at 30 days
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Institute for Health Research IdiPAZ
Study officials:
affiliation: La Paz University Hospital
name: Carmen Gómez-Candela
role: PRINCIPAL_INVESTIGATOR
References: