Overweight and ObesityNCT06114563
Effects of Yogurt With Spirulina on Cardiometabolic Risk Markers
A study testing Spirulina yogurt and Conventional yogurt in people with Overweight and Obesity and PreDiabetes, run by Agricultural University of Athens at 1 site in Greece.
Trial summary
The effects of yogurt with spirulina consumption compared to conventional yogurt (without spirulina) on several cardiometabolic and anthropometric parameters in individuals at risk of cardiovascular disease Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Overweight and Obesity, PreDiabetes, Hypertension
- What is being tested?
- Spirulina yogurt and Conventional yogurt
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteGreece
- Study dates
- 1 Feb 2023to 15 Sep 2023
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Body Mass Index >= 25 kg/m2
- Prediabetes [Fasting blood glucose > 100 mg/dL], or/and
- Hypertension [Systolic blood pressure (SBP) > 130 mmHg or Diastolic blood pressure (DBP) > 80 mmHg], or/and
- Hyperlipidemia [Total cholesterol > 200 mg/dL, and/or LDL-C > 100 mg/dL, and/or triglycerides > 150 mg/dL]
Who cannot join
- Severe chronic disease (e.g. cardiovascular diseases, diabetes mellitus, kidney or liver diseases, endocrine conditions)
- Medication that affects glycemia such as metformin, glucocorticoids, thiazide diuretics
- Gastrointestinal disorders
- Pregnancy
- Lactation
- Alcohol abuse
Show all 11Show fewer
- Drug dependency
- Body weight lowering medications and/or history of bariatric surgery
- Depression and other psychiatric diseases
- Cancer
- Current spirulina intake
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Yogurt With Spirulina Consumption in High Cardiometabolic Risk Individuals
The effects of yogurt with spirulina consumption compared to conventional yogurt (without spirulina) on several cardiometabolic and anthropometric parameters in individuals at risk of cardiovascular disease
Read the detailed description
This randomized, double-blind, controlled clinical trial aims to evaluate the effects of the consumption of yogurt with spirulina compared to conventional yogurt in high cardiometabolic risk volunteers. Volunteers must be overweight/obese either with prediabetes, and/or hypertension, and/or hyperlipidemia and following a Westernized-type diet. The participants will be divided and randomly assigned into 2 groups. Each participant will be instructed to consume two 200 g servings of their designated low-fat sheep yogurt daily before consuming the main meal. The intervention group will receive two spirulina-enriched yogurt desserts daily, which will provide a total of 4 g spirulina per day, while the control group will receive unfortified yogurt along with their usual Westernized-type diet. Participants in both groups will be instructed to consume the two yogurts (enriched or plain), either all at once or separately, before their main meals, along with their usual Westernized diet. No other dietary advice will be provided to participants.
Participants will be asked to maintain their usual physical activity during the intervention period. At the beginning of the study, at 8 weeks, and 12 weeks after the beginning of the intervention (follow-up), blood samples will be collected after 12 hours of fasting. Two-hour oral glucose tolerance test (OGTT) will be performed using a continuous glucose monitoring system at the beginning and at 8 weeks. Blood lipids (total cholesterol, HDL-cholesterol, triglycerides, and LDL-cholesterol), CRP, IL-6, vitamin D, iron, ferritin, and total blood count will be measured at the beginning, 8 weeks, and 12 weeks. Anthropometric measurements (body weight and body composition analysis) will be performed at the beginning and every two weeks for 12 weeks. Basal metabolic rate (BMR) and central aortic blood pressure will be measured at the beginning, 4 weeks, 8 weeks, and 12 weeks of the intervention. Fecal samples will be collected and analyzed to study the gut microbiome composition at the intervention's beginning and at 8 weeks.
- Conditions
- Overweight and Obesity, PreDiabetes, Hypertension, Dyslipidemias
- Being tested
- Spirulina yogurt, Conventional yogurt
- Keywords
- spirulina, yogurt, cardiometabolic risk factors
- Medical subject headings
- Overweight, Obesity, Prediabetic State, Hypertension, Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spirulina yogurtOther
High cardiometabolic risk volunteers will be asked to consume 2 yogurts with spirulina, each containing 2 g spirulina, daily for 8 weeks, without any other change in their dietary habits and physical activity.
Conventional yogurtOther
High cardiometabolic risk volunteers will be asked to consume 2 conventional yogurts (without spirulina), daily for 8 weeks, without any other change in their dietary habits and physical activity.
| Study group | Role | What they receive |
|---|---|---|
| Spirulina yogurt | Experimental | 2 yogurts with spirulina each containing 2 g of spirulina Receives: Other: Spirulina yogurt |
| Conventional yogurt | Active comparator | 2 conventional yogurts (without spirulina) Receives: Other: Conventional yogurt |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Fasting Blood Glucose Levels
Blood glucose levels were determined at baseline, end of study, and at 12 weeks
Measured: Baseline, 8 weeks and 12 weeks outcome measurement (3 months)
Change in Total Cholesterol Levels
Total cholesterol levels were determined at baseline, end of study, and at 12 weeks after dietary intervention
Measured: Baseline, 8 weeks and 12 weeks outcome measurement (3 months)
Change in HDL-cholesterol Levels
HDL-cholesterol levels were determined at baseline, end of study, and at 12 weeks after dietary intervention
Measured: Baseline, 8 weeks and 12 weeks outcome measurement (3 months)
Change in LDL-cholesterol Levels
LDL-cholesterol levels were determined before diet intervention, at 8 weeks, LDL-cholesterol levels were determined at baseline, end of study, and at 12 weeks after dietary intervention
Measured: Baseline and end of 8 weeks and at 12 weeks follow-up outcome measurement (3 months)
Systolic Blood Pressure
Systolic blood pressure levels were determined at baseline, end of study, and at 12 weeks after dietary intervention
Measured: Baseline and end of 8 weeks and at 12 weeks follow-up outcome measurement (3 months)
Change in Triglyceride Levels
Triglyceride levels were determined before diet intervention, at 8 weeks, levels were determined at baseline, end of study, and at 12 weeks after dietary intervention
Measured: Baseline and end of 8 weeks and at 12 weeks outcome measurement (3 months)
Diastolic Blood Pressure
Diastolic blood pressure levels were determined at baseline, end of study, and at 12 weeks after dietary intervention
Measured: Baseline and end of 8 weeks and at 12 weeks outcome measurement (3 months)
Secondary outcomes (17)
Change in energy intake
Change in energy intake (kcal/day) over the course of the study
Measured: Baseline to 12 weeks (3 months)
Change in Blood Insulin Levels
Blood insulin levels were determined before diet intervention, at 8 weeks, and at 12 weeks after diet intervention
Measured: Baseline and end of 8 weeks and at 12 weeks outcome measurement (3 months)
Oral Glucose Tolerance Test (OGGT) for Insulin Resistance Determination (Outcome Measures of Plasma Glucose Concentrations)
Pharmacokinetic outcome measures: Determination of insulin resistance with OGGT testing. Before and after oral consumption of 75 g of glucose, capillary glucose concentrations were measured at the following times: 0 min - before oral consumption of 75 g glucose, 30 min, 60 min, 90 min, and 120 min after oral consumption of 75 g glucose
Measured: Outcome OGGT measurements performed before dietary intervention and after 8-week dietary intervention (2 months)
Change in basal metabolic rate (BMR)
Change in basal metabolic rate (kcal/day) over the course of the study
Measured: Baseline to 12 weeks (3 months)
Change in central aortic blood pressure
Significant change in central pressure (mmHg)
Measured: Baseline to 8 weeks and to 12 weeks (3 months)
Change in body weight
Change in body weight over the course of the study
Measured: Baseline to 12 weeks (3 months)
Change in gut microbiome
The microbial composition in fecal samples will be measured via taxonomic profiling by 16S (V3-V4 region) ribosomal RNA gene amplicon sequencing using the MiSeq Illumina platform (v3 300bp pair-end sequencing) to identify a wide diversity of microbes
Measured: Baseline to 8 weeks (2 months)
Time in target glucose range
Time spent in target glucose range of 70 to 180 mg/dL using FreeStyle Libre Continuous Glucose Monitor System
Measured: Baseline to 8 weeks (2 months)
Glucose management indicator
Continuous glucose measurement (CGM) metric that indicates average blood glucose
Measured: Baseline to 8 weeks (2 months)
Co-efficient of variation of glucose
CGM metric that measures variability in CGM values
Measured: Baseline to 8 weeks (2 months)
Physical activity measures
Number of minutes of physical activity in the past week before visit
Measured: Baseline to 12 weeks (3 months)
Change in Pulse Wave Velocity (PWV)
PWV using a noninvasive device was measured at baseline, 8 weeks, and 12 weeks after diet intervention
Measured: Baseline to 12 weeks (3 months)
Change in C-reactive Protein levels
C-reactive Protein levels were measured at baseline, 8 weeks, and 12 weeks after diet intervention
Measured: Baseline to 12 weeks (3 months)
Change in interleukin-6 (IL-6) levels
IL-6 levels were measured at baseline, 8 weeks, and 12 weeks after diet intervention
Measured: Baseline to 12 weeks (3 months)
Change in vitamin D levels
vitamin D levels were measured at baseline, 8 weeks, and 12 weeks after diet intervention
Measured: Baseline to 12 weeks (3 months)
Change in serum iron levels
Serum iron levels were measured at baseline, 8 weeks, and 12 weeks after diet intervention
Measured: Baseline to 12 weeks (3 months)
Change in ferritin levels
Ferritin levels were measured at baseline, 8 weeks, and 12 weeks after diet intervention
Measured: Baseline to 12 weeks (3 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2023
- Study start1 Feb 2023
- Primary completion31 Jul 2023
- Study completion15 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Overweight and ObesityStudies 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, Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Agricultural University of Athens
- Sponsor type
- University, hospital or other
- Collaborators
- Hellenic Agricultural Organization DEMETER
- Responsible party
- Principal investigator, Aimilia Papakonstantinou, Agricultural University of Athens
- Investigators
- Emilia Papakonstantinou, PhD, Principal investigator, Agricultural University of Athens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06114563
- Sponsor's protocol ID
- HRBD 41/26.05.2023
- Status last verified
- Jun 2024
- First submitted
- 18 Oct 2023
- Last updated
- 11 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Papakonstantinou E, Lympaki F, Savvidou A, Dalaka E, Georgiopoulos G, Giannoglou M, Karatzi K, Chaloulakou S, Delialis D, Keramida K, Zampelas A, Katsaros G, Theodorou G. Impact of spirulina-enriched yogurt-like dessert on blood pressure in overweight individuals with high cardiometabolic risk: results from in vitro studies and a randomized, placebo-controlled clinical trial. Nutr Metab Cardiovasc Dis. 2026 Jun 10:104824. doi: 10.1016/j.numecd.2026.104824. Online ahead of print.
PubMed 42321101
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Yogurt With Spirulina Consumption in High Cardiometabolic Risk Individuals
- ClinicalTrials.gov ID
- NCT06114563
- Acronym / sponsor ID
- HRBD 41/26.05.2023
- Conditions
- Overweight and Obesity, PreDiabetes, Hypertension, Dyslipidemias
- Keywords
- spirulina, yogurt, cardiometabolic risk factors
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Agricultural University of AthensUniversity, hospital or other
- Collaborators
- Hellenic Agricultural Organization DEMETER
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 31 Jul 2023 (actual)
- Study completion
- 15 Sep 2023 (actual)
- First posted
- 2 Nov 2023 (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 effects of yogurt with spirulina consumption compared to conventional yogurt (without spirulina) on several cardiometabolic and anthropometric parameters in individuals at risk of cardiovascular disease
Detailed description
This randomized, double-blind, controlled clinical trial aims to evaluate the effects of the consumption of yogurt with spirulina compared to conventional yogurt in high cardiometabolic risk volunteers. Volunteers must be overweight/obese either with prediabetes, and/or hypertension, and/or hyperlipidemia and following a Westernized-type diet. The participants will be divided and randomly assigned into 2 groups. Each participant will be instructed to consume two 200 g servings of their designated low-fat sheep yogurt daily before consuming the main meal. The intervention group will receive two spirulina-enriched yogurt desserts daily, which will provide a total of 4 g spirulina per day, while the control group will receive unfortified yogurt along with their usual Westernized-type diet. Participants in both groups will be instructed to consume the two yogurts (enriched or plain), either all at once or separately, before their main meals, along with their usual Westernized diet. No other dietary advice will be provided to participants.
Participants will be asked to maintain their usual physical activity during the intervention period. At the beginning of the study, at 8 weeks, and 12 weeks after the beginning of the intervention (follow-up), blood samples will be collected after 12 hours of fasting. Two-hour oral glucose tolerance test (OGTT) will be performed using a continuous glucose monitoring system at the beginning and at 8 weeks. Blood lipids (total cholesterol, HDL-cholesterol, triglycerides, and LDL-cholesterol), CRP, IL-6, vitamin D, iron, ferritin, and total blood count will be measured at the beginning, 8 weeks, and 12 weeks. Anthropometric measurements (body weight and body composition analysis) will be performed at the beginning and every two weeks for 12 weeks. Basal metabolic rate (BMR) and central aortic blood pressure will be measured at the beginning, 4 weeks, 8 weeks, and 12 weeks of the intervention. Fecal samples will be collected and analyzed to study the gut microbiome composition at the intervention's beginning and at 8 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Spirulina yogurt | Experimental | Other: Spirulina yogurt2 yogurts with spirulina each containing 2 g of spirulina |
| Conventional yogurt | Active comparator | Other: Conventional yogurt2 conventional yogurts (without spirulina) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Body Mass Index >= 25 kg/m2
- Prediabetes [Fasting blood glucose > 100 mg/dL], or/and
- Hypertension [Systolic blood pressure (SBP) > 130 mmHg or Diastolic blood pressure (DBP) > 80 mmHg], or/and
- Hyperlipidemia [Total cholesterol > 200 mg/dL, and/or LDL-C > 100 mg/dL, and/or triglycerides > 150 mg/dL]
Key exclusion criteria (11 listed)
- Severe chronic disease (e.g. cardiovascular diseases, diabetes mellitus, kidney or liver diseases, endocrine conditions)
- Medication that affects glycemia such as metformin, glucocorticoids, thiazide diuretics
- Gastrointestinal disorders
- Pregnancy
- Lactation
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 |
|---|---|---|
| Spirulina yogurtHigh cardiometabolic risk volunteers will be asked to consume 2 yogurts with spirulina, each containing 2 g spirulina, daily for 8 weeks, without any other change in their dietary habits and physical activity. | Other | Spirulina yogurt |
| Conventional yogurtHigh cardiometabolic risk volunteers will be asked to consume 2 conventional yogurts (without spirulina), daily for 8 weeks, without any other change in their dietary habits and physical activity. | Other | Conventional yogurt |
Primary outcome
Change in Fasting Blood Glucose Levels
Time frame: Baseline, 8 weeks and 12 weeks outcome measurement (3 months)
Blood glucose levels were determined at baseline, end of study, and at 12 weeks
Change in Total Cholesterol Levels
Time frame: Baseline, 8 weeks and 12 weeks outcome measurement (3 months)
Total cholesterol levels were determined at baseline, end of study, and at 12 weeks after dietary intervention
Change in HDL-cholesterol Levels
Time frame: Baseline, 8 weeks and 12 weeks outcome measurement (3 months)
HDL-cholesterol levels were determined at baseline, end of study, and at 12 weeks after dietary intervention
Change in LDL-cholesterol Levels
Time frame: Baseline and end of 8 weeks and at 12 weeks follow-up outcome measurement (3 months)
LDL-cholesterol levels were determined before diet intervention, at 8 weeks, LDL-cholesterol levels were determined at baseline, end of study, and at 12 weeks after dietary intervention
Systolic Blood Pressure
Time frame: Baseline and end of 8 weeks and at 12 weeks follow-up outcome measurement (3 months)
Systolic blood pressure levels were determined at baseline, end of study, and at 12 weeks after dietary intervention
Change in Triglyceride Levels
Time frame: Baseline and end of 8 weeks and at 12 weeks outcome measurement (3 months)
Triglyceride levels were determined before diet intervention, at 8 weeks, levels were determined at baseline, end of study, and at 12 weeks after dietary intervention
Diastolic Blood Pressure
Time frame: Baseline and end of 8 weeks and at 12 weeks outcome measurement (3 months)
Diastolic blood pressure levels were determined at baseline, end of study, and at 12 weeks after dietary intervention
17 secondary outcomes
Change in energy intake
Time frame: Baseline to 12 weeks (3 months)
Change in Blood Insulin Levels
Time frame: Baseline and end of 8 weeks and at 12 weeks outcome measurement (3 months)
Oral Glucose Tolerance Test (OGGT) for Insulin Resistance Determination (Outcome Measures of Plasma Glucose Concentrations)
Time frame: Outcome OGGT measurements performed before dietary intervention and after 8-week dietary intervention (2 months)
Change in basal metabolic rate (BMR)
Time frame: Baseline to 12 weeks (3 months)
Change in central aortic blood pressure
Time frame: Baseline to 8 weeks and to 12 weeks (3 months)
Change in body weight
Time frame: Baseline to 12 weeks (3 months)
Change in gut microbiome
Time frame: Baseline to 8 weeks (2 months)
Time in target glucose range
Time frame: Baseline to 8 weeks (2 months)
Glucose management indicator
Time frame: Baseline to 8 weeks (2 months)
Co-efficient of variation of glucose
Time frame: Baseline to 8 weeks (2 months)
Physical activity measures
Time frame: Baseline to 12 weeks (3 months)
Change in Pulse Wave Velocity (PWV)
Time frame: Baseline to 12 weeks (3 months)
Change in C-reactive Protein levels
Time frame: Baseline to 12 weeks (3 months)
Change in interleukin-6 (IL-6) levels
Time frame: Baseline to 12 weeks (3 months)
Change in vitamin D levels
Time frame: Baseline to 12 weeks (3 months)
Change in serum iron levels
Time frame: Baseline to 12 weeks (3 months)
Change in ferritin levels
Time frame: Baseline to 12 weeks (3 months)
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 Jun 2024.
- Derived from this study: PubMed 42321101Papakonstantinou E, Lympaki F, Savvidou A, Dalaka E, Georgiopoulos G, Giannoglou M, Karatzi K, Chaloulakou S, Delialis D, Keramida K, Zampelas A, Katsaros G, Theodorou G. Impact of spirulina-enriched yogurt-like dessert on blood pressure in overweight individuals with high cardiometabolic risk: results from in vitro studies and a randomized, placebo-controlled clinical trial. Nutr Metab Cardiovasc Dis. 2026 Jun 10:104824. doi: 10.1016/j.numecd.2026.104824. Online ahead of print.
- Individual participant dataSharing planned: No
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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.
Emilia Papakonstantinou, PhD principal investigator
Agricultural University of Athens
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spirulina yogurt and Conventional yogurt in people with Overweight and Obesity and PreDiabetes, run by Agricultural University of Athens at 1 site in Greece.
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 4 inclusion and 11 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 Jun 2024. 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 Greece. 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. 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?
Change in Fasting Blood Glucose Levels (time frame: Baseline, 8 weeks and 12 weeks outcome measurement (3 months)). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06114563, which also lists 1 linked publication.
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 Jun 2024.