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| Name | Class |
|---|---|
| Hellenic Agricultural Organization DEMETER | UNKNOWN |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Spirulina yogurt | Experimental | 2 yogurts with spirulina each containing 2 g of spirulina |
|
| Conventional yogurt | Active Comparator | 2 conventional yogurts (without spirulina) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Spirulina yogurt | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Fasting Blood Glucose Levels | Blood glucose levels were determined at baseline, end of study, and at 12 weeks | 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 | 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 | 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 | 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 | 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 | Baseline and end of 8 weeks and at 12 weeks outcome measurement (3 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in energy intake | Change in energy intake (kcal/day) over the course of the study | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Emilia Papakonstantinou, PhD | Agricultural University of Athens | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Agricultural University of Athens | Athens | Attica | 11855 | Greece |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42321101 | Derived | 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. |
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| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| D011236 | Prediabetic State |
| D006973 | Hypertension |
| D050171 | Dyslipidemias |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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Double-blind
| Conventional yogurt | Other | 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. |
|
| Diastolic Blood Pressure | Diastolic blood pressure levels were determined at baseline, end of study, and at 12 weeks after dietary intervention | Baseline and end of 8 weeks and at 12 weeks outcome measurement (3 months) |
| 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 | 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 | Baseline to 12 weeks (3 months) |
| Change in central aortic blood pressure | Significant change in central pressure (mmHg) | Baseline to 8 weeks and to 12 weeks (3 months) |
| Change in body weight | Change in body weight over the course of the study | 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 | 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 | Baseline to 8 weeks (2 months) |
| Glucose management indicator | Continuous glucose measurement (CGM) metric that indicates average blood glucose | Baseline to 8 weeks (2 months) |
| Co-efficient of variation of glucose | CGM metric that measures variability in CGM values | Baseline to 8 weeks (2 months) |
| Physical activity measures | Number of minutes of physical activity in the past week before visit | 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 | 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 | 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 | 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 | 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 | Baseline to 12 weeks (3 months) |
| Change in ferritin levels | Ferritin levels were measured at baseline, 8 weeks, and 12 weeks after diet intervention | Baseline to 12 weeks (3 months) |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D052439 | Lipid Metabolism Disorders |