PostmenopauseNCT07718399
Spirulina Supplementation in Postmenopausal Women
A study testing Spirulina in people with Postmenopause and Overweight, run by Halic University at 1 site in Turkey (Türkiye).
Trial summary
The purpose of this study is to investigate the effects of spirulina supplementation on weight gain associated with menopause, changes in metabolic parameters, sleep quality, and markers of depression in mildly overweight postmenopausal women, and to evaluate the changes that occur in these parameters. Read more about this study
- Who is it for?
- Ages 45 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postmenopause, Overweight
- What is being tested?
- Spirulina
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jul 2026to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 45 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Volunteering to participate in the study
- Having a body mass index (BMI) between 25 and 29.9 kg/m²
- Having no chronic illnesses
- Being between the ages of 45 and 65
- Being postmenopausal
- Willing to consume the provided supplement
- Individuals who can read and write in Turkish and are open to communication.
Who cannot join
- Having a chronic condition such as diabetes, hypertension, cancer, metabolic syndrome, chronic kidney disease, dyslipidemia, etc.
- Having a congenital metabolic disorder
- Being in the experimental group but not taking the supplement regularly
- Taking medication to lower blood lipids
- Having an allergy to any food
- Not being in the postmenopausal period
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Haliç University Faculty of Health Sciences
Istanbul, eyüpsultan, 34060
Niran Çomak, Dietitian, 905432670224, niran_cmk@hotmail.com
About this study
Official title: The Effect of Spirulina Supplementation on Metabolic Parameters, Body Composition, Depression, and Sleep Quality in Postmenopausal Women: A Randomized Controlled Trial
The purpose of this study is to investigate the effects of spirulina supplementation on weight gain associated with menopause, changes in metabolic parameters, sleep quality, and markers of depression in mildly overweight postmenopausal women, and to evaluate the changes that occur in these parameters.
Read the detailed description
Menopause is defined as the spontaneous and permanent cessation of menstrual bleeding in women due to the loss of ovarian function. The onset of menopause brings about many physiological and psychological symptoms. Certain hormonal changes increase the risk of chronic diseases such as high waist circumference, cardiovascular diseases, obesity, diabetes, and osteoporosis. Spirulina platensis contains approximately 50-70% protein, 15-25% carbohydrates, 6-13% lipids, 4.2-6% nucleic acids, and 2.2-4.8% minerals by dry weight. Polyunsaturated fatty acids (PUFAs) constitute 1.5-2% of the total lipid content. It is rich in essential amino acids (especially leucine, isoleucine, valine), γ-linolenic acid (36% of total FDA), vitamins (thiamine, niacin, riboflavin, pyridoxine, folic acid, cobalamin, C, D and E), minerals (potassium, calcium, chromium, copper, iron, magnesium, manganese, phosphorus, selenium, sodium and zinc), pigments (chlorophyll a, xanthophyll, beta-carotene, echinone, myxoxanthophyll, zeaxanthin, canthaxanthin, diathoxanthin, 3-hydroxyechinone, beta-cryptoxanthin and ossilaxanthin, phycobiliprotein, C-phycocyanin, allophycocyanin) and enzymes (lipase, superoxide dismutase, etc.). Many of the beneficial effects of spirulina on health, which contains powerful antioxidants such as carotenoids, chlorophyll, and phycocyanin, stem from its antioxidant properties. Spirulina supplementation is considered effective as a therapeutic tool in the management of multiple interconnected metabolic abnormalities such as dyslipidemia, glucose intolerance, obesity, and hypertension. This study aimed to investigate the effects of spirulina supplementation on weight gain associated with menopause, changes in metabolic parameters, sleep quality, and markers of depression in mildly obese postmenopausal women.
- Conditions
- Postmenopause, Overweight
- Being tested
- Spirulina, Placebo
- Keywords
- spirulina, depression, postmenopause, overweight, Sleep Quality, lipid profile, blood glucose, metabolic parameters
- Medical subject headings
- Overweight, Depression, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SpirulinaDietary supplement
Participants will receive 2 g/day spirulina tablets for 8 weeks.
PlaceboOther
Participants will receive matching placebo tablets for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Placebo Group | Placebo comparator | It will be administered to the control group. Tablets containing starch and food coloring will be administered at a dose of 2 g/day. Receives: Other: Placebo |
| Spirulina Group | Active comparator | It will be administered to the experimental group. The participants will be given 2 g of spirulina tablets per day. Receives: Dietary Supplement: Spirulina |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fasting Blood Glucose
Fasting blood glucose (mg/dL) will be measured at baseline and Week 8 to evaluate the effect of spirulina supplementation.
Measured: Baseline and Week 8
HbA1c
HbA1c (%) will be measured at baseline and Week 8 to assess long-term glycemic control.
Measured: Baseline and Week 8
HOMA-IR
Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) will be calculated using fasting glucose and fasting insulin measurements obtained at baseline and Week 8.
Measured: Baseline and Week 8
Total Cholesterol
Total cholesterol concentration (mg/dL) will be measured at baseline and Week 8.
Measured: Baseline and Week 8
LDL Cholesterol
Low-density lipoprotein (LDL) cholesterol concentration (mg/dL) will be measured at baseline and Week 8.
Measured: Baseline and Week 8
HDL Cholesterol
High-density lipoprotein (HDL) cholesterol concentration (mg/dL) will be measured at baseline and Week 8.
Measured: Baseline and Week 8
Triglycerides
Serum triglyceride concentration (mg/dL) will be measured at baseline and Week 8.
Measured: Baseline and Week 8
Secondary outcomes (12)
Body Weight
Body weight (kg) will be measured at baseline and Week 8.
Measured: Baseline and Week 8
Body Mass Index
Body mass index (BMI, kg/m²) will be calculated from measured height and body weight and assessed at baseline and Week 8.
Measured: Baseline and Week 8
Waist Circumference
Waist circumference (cm) will be measured at baseline and Week 8.
Measured: Baseline and Week 8
Hip Circumference
Hip circumference (cm) will be measured at baseline and Week 8.
Measured: Baseline and Week 8
Mid-Upper Arm Circumference
Mid-upper arm circumference (cm) will be measured at baseline and Week 8.
Measured: Baseline and Week 8
Waist-to-Height Ratio
Waist-to-height ratio will be calculated using waist circumference and height measurements obtained at baseline and Week 8.
Measured: Baseline and Week 8
Body Fat Percentage
Body fat percentage (%) will be assessed using bioelectrical impedance analysis at baseline and Week 8.
Measured: Baseline and Week 8
Body Fat Mass
Body fat mass (kg) will be assessed using bioelectrical impedance analysis at baseline and Week 8.
Measured: Baseline and Week 8
Total Body Water
Total body water (kg) will be assessed using bioelectrical impedance analysis at baseline and Week 8.
Measured: Baseline and Week 8
Skeletal Muscle Mass
Skeletal muscle mass (kg) will be assessed using bioelectrical impedance analysis at baseline and Week 8.
Measured: Baseline and Week 8
The Depression, Anxiety and Stress Scale-21 (DASS-21)
The Depression Anxiety Stress Scale-21 (DASS-21) is a 21-item self-report questionnaire used to assess depression, anxiety, and stress symptoms. Each item is scored on a 4-point Likert scale ranging from 0 to 3. Higher scores indicate greater psychological distress. Changes in DASS-21 scores from baseline to Week 8 will be evaluated.
Measured: eight weeks
Pittsburgh Sleep Quality Index (PSQI)
The Pittsburgh Sleep Quality Index (PSQI) consists of a total of 24 questions designed to assess an individual's sleep quality over the past month. Nineteen of these questions are self-report questions answered by the individual; the remaining five are answered by the individual's spouse or roommate. Each component is scored on a scale of 0 to 3. The sum of these component scores yields a total PSQI score ranging from 0 to 21. A score of 0-5 is considered good sleep quality, while a score of 6-21 is considered poor sleep quality.
Measured: eight weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2026
- Study startJul 2026 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PostmenopauseStudies 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
- Model description
- two groups with a control group and an experimental group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Halic University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Niran Çomak, Halic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07718399
- Sponsor's protocol ID
- HalicU-SBF-NC-01
- Status last verified
- Jul 2026
- First submitted
- 23 Jun 2026
- Last updated
- 22 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Spirulina Supplementation on Metabolic Parameters, Body Composition, Depression, and Sleep Quality in Postmenopausal Women: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07718399
- Acronym / sponsor ID
- HalicU-SBF-NC-01
- Conditions
- Postmenopause, Overweight
- Keywords
- spirulina, depression, postmenopause, overweight, Sleep Quality, lipid profile, blood glucose, metabolic parameters
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Halic UniversityUniversity, hospital or other
- Study start
- Jul 2026 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 22 Jul 2026 (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 investigate the effects of spirulina supplementation on weight gain associated with menopause, changes in metabolic parameters, sleep quality, and markers of depression in mildly overweight postmenopausal women, and to evaluate the changes that occur in these parameters.
Detailed description
Menopause is defined as the spontaneous and permanent cessation of menstrual bleeding in women due to the loss of ovarian function. The onset of menopause brings about many physiological and psychological symptoms. Certain hormonal changes increase the risk of chronic diseases such as high waist circumference, cardiovascular diseases, obesity, diabetes, and osteoporosis. Spirulina platensis contains approximately 50-70% protein, 15-25% carbohydrates, 6-13% lipids, 4.2-6% nucleic acids, and 2.2-4.8% minerals by dry weight. Polyunsaturated fatty acids (PUFAs) constitute 1.5-2% of the total lipid content. It is rich in essential amino acids (especially leucine, isoleucine, valine), γ-linolenic acid (36% of total FDA), vitamins (thiamine, niacin, riboflavin, pyridoxine, folic acid, cobalamin, C, D and E), minerals (potassium, calcium, chromium, copper, iron, magnesium, manganese, phosphorus, selenium, sodium and zinc), pigments (chlorophyll a, xanthophyll, beta-carotene, echinone, myxoxanthophyll, zeaxanthin, canthaxanthin, diathoxanthin, 3-hydroxyechinone, beta-cryptoxanthin and ossilaxanthin, phycobiliprotein, C-phycocyanin, allophycocyanin) and enzymes (lipase, superoxide dismutase, etc.). Many of the beneficial effects of spirulina on health, which contains powerful antioxidants such as carotenoids, chlorophyll, and phycocyanin, stem from its antioxidant properties. Spirulina supplementation is considered effective as a therapeutic tool in the management of multiple interconnected metabolic abnormalities such as dyslipidemia, glucose intolerance, obesity, and hypertension. This study aimed to investigate the effects of spirulina supplementation on weight gain associated with menopause, changes in metabolic parameters, sleep quality, and markers of depression in mildly obese postmenopausal women.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- two groups with a control group and an experimental group
| Arm | Type | Receives |
|---|---|---|
| Placebo Group | Placebo comparator | Other: PlaceboIt will be administered to the control group. Tablets containing starch and food coloring will be administered at a dose of 2 g/day. |
| Spirulina Group | Active comparator | Dietary Supplement: SpirulinaIt will be administered to the experimental group. The participants will be given 2 g of spirulina tablets per day. |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Volunteering to participate in the study
- Having a body mass index (BMI) between 25 and 29.9 kg/m²
- Having no chronic illnesses
- Being between the ages of 45 and 65
- Being postmenopausal
Key exclusion criteria (6 listed)
- Having a chronic condition such as diabetes, hypertension, cancer, metabolic syndrome, chronic kidney disease, dyslipidemia, etc.
- Having a congenital metabolic disorder
- Being in the experimental group but not taking the supplement regularly
- Taking medication to lower blood lipids
- Having an allergy to any food
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 |
|---|---|---|
| SpirulinaParticipants will receive 2 g/day spirulina tablets for 8 weeks. | Dietary supplement | Spirulina Group |
| PlaceboParticipants will receive matching placebo tablets for 8 weeks. | Other | Placebo Group |
Primary outcome
Fasting Blood Glucose
Time frame: Baseline and Week 8
Fasting blood glucose (mg/dL) will be measured at baseline and Week 8 to evaluate the effect of spirulina supplementation.
HbA1c
Time frame: Baseline and Week 8
HbA1c (%) will be measured at baseline and Week 8 to assess long-term glycemic control.
HOMA-IR
Time frame: Baseline and Week 8
Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) will be calculated using fasting glucose and fasting insulin measurements obtained at baseline and Week 8.
Total Cholesterol
Time frame: Baseline and Week 8
Total cholesterol concentration (mg/dL) will be measured at baseline and Week 8.
LDL Cholesterol
Time frame: Baseline and Week 8
Low-density lipoprotein (LDL) cholesterol concentration (mg/dL) will be measured at baseline and Week 8.
HDL Cholesterol
Time frame: Baseline and Week 8
High-density lipoprotein (HDL) cholesterol concentration (mg/dL) will be measured at baseline and Week 8.
Triglycerides
Time frame: Baseline and Week 8
Serum triglyceride concentration (mg/dL) will be measured at baseline and Week 8.
12 secondary outcomes
Body Weight
Time frame: Baseline and Week 8
Body Mass Index
Time frame: Baseline and Week 8
Waist Circumference
Time frame: Baseline and Week 8
Hip Circumference
Time frame: Baseline and Week 8
Mid-Upper Arm Circumference
Time frame: Baseline and Week 8
Waist-to-Height Ratio
Time frame: Baseline and Week 8
Body Fat Percentage
Time frame: Baseline and Week 8
Body Fat Mass
Time frame: Baseline and Week 8
Total Body Water
Time frame: Baseline and Week 8
Skeletal Muscle Mass
Time frame: Baseline and Week 8
The Depression, Anxiety and Stress Scale-21 (DASS-21)
Time frame: eight weeks
Pittsburgh Sleep Quality Index (PSQI)
Time frame: eight weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2026.
- Individual participant dataSharing planned: No
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RecruitingObservational study
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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.
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 in people with Postmenopause and Overweight, run by Halic University at 1 site in Turkey (Türkiye).
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 7 inclusion and 6 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: opening soon, as of the sponsor's last update on 22 Jul 2026. 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 Turkey (Türkiye). 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Niran ÇOMAK, Dietitian (905432670224, niran_cmk@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fasting Blood Glucose (time frame: Baseline and Week 8). 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?
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 22 Jul 2026.