An interventional study of Spirulina and Placebo in Postmenopause and Overweight, sponsored by Halic University. Not yet recruiting at 1 site in Turkey (Türkiye). Open to female participants aged 45 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-22.
Sponsored by Halic University · Not applicable, Interventional, and Treatment
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.
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.
3,599 studies on the registry are indexed under Overweight; 852 are open to participants now.
This study's planned enrollment of 66 is below the median of 78 across 3,120 interventional studies indexed under Overweight.
Browse Overweight studies →Halic University is the lead sponsor of 85 studies on the registry; 14 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
It will be administered to the control group. Tablets containing starch and food coloring will be administered at a dose of 2 g/day.
Other: Placebo
It will be administered to the experimental group. The participants will be given 2 g of spirulina tablets per day.
Dietary Supplement: Spirulina
Participants will receive 2 g/day spirulina tablets for 8 weeks.
Participants will receive matching placebo tablets for 8 weeks.
Fasting Blood Glucose
Fasting blood glucose (mg/dL) will be measured at baseline and Week 8 to evaluate the effect of spirulina supplementation.
Time frame: Baseline and Week 8
HbA1c
HbA1c (%) will be measured at baseline and Week 8 to assess long-term glycemic control.
Time frame: 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.
Time frame: Baseline and Week 8
Total Cholesterol
Total cholesterol concentration (mg/dL) will be measured at baseline and Week 8.
Time frame: Baseline and Week 8
LDL Cholesterol
Low-density lipoprotein (LDL) cholesterol concentration (mg/dL) will be measured at baseline and Week 8.
Time frame: Baseline and Week 8
HDL Cholesterol
High-density lipoprotein (HDL) cholesterol concentration (mg/dL) will be measured at baseline and Week 8.
Time frame: Baseline and Week 8
Triglycerides
Serum triglyceride concentration (mg/dL) will be measured at baseline and Week 8.
Time frame: Baseline and Week 8
Body Weight
Body weight (kg) will be measured at baseline and Week 8.
Time frame: 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.
Time frame: Baseline and Week 8
Waist Circumference
Waist circumference (cm) will be measured at baseline and Week 8.
Time frame: Baseline and Week 8
Hip Circumference
Hip circumference (cm) will be measured at baseline and Week 8.
Time frame: Baseline and Week 8
Mid-Upper Arm Circumference
Mid-upper arm circumference (cm) will be measured at baseline and Week 8.
Time frame: 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.
Time frame: Baseline and Week 8
Body Fat Percentage
Body fat percentage (%) will be assessed using bioelectrical impedance analysis at baseline and Week 8.
Time frame: Baseline and Week 8
Body Fat Mass
Body fat mass (kg) will be assessed using bioelectrical impedance analysis at baseline and Week 8.
Time frame: Baseline and Week 8
Total Body Water
Total body water (kg) will be assessed using bioelectrical impedance analysis at baseline and Week 8.
Time frame: Baseline and Week 8
Skeletal Muscle Mass
Skeletal muscle mass (kg) will be assessed using bioelectrical impedance analysis at baseline and Week 8.
Time frame: 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.
Time frame: 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.
Time frame: eight weeks
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Jul 2026; primary completion for Dec 2026, 5 months later.
Of 1,300 non-industry interventional studies with no phase under Overweight, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 38. This study's planned 5 months is below that.
Counting every sponsor, half of 1,411 studies reached it within 17 months; a quarter within 8 and three quarters within 38.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Spirulina maxima
Halic University