Spirulina Supplementation in Postmenopausal Women
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Spirulina, Placebo.
- Who it may be relevant to
- Registry conditions: Postmenopause, Overweight. Basic parameters: 45 years — 65 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Turkey (Türkiye)
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
The Effect of Spirulina Supplementation on Metabolic Parameters, Body Composition, Depression, and Sleep Quality in Postmenopausal Women: A Randomized Controlled Trial
Overview
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.
Interventions
- Dietary supplement Spirulina
Participants will receive 2 g/day spirulina tablets for 8 weeks. - Other Placebo
Participants will receive matching placebo tablets for 8 weeks.
Primary outcome measures
- Fasting Blood Glucose [Time frame: Baseline and Week 8]
- HbA1c [Time frame: Baseline and Week 8]
- HOMA-IR [Time frame: Baseline and Week 8]
- Total Cholesterol [Time frame: Baseline and Week 8]
- LDL Cholesterol [Time frame: Baseline and Week 8]
- HDL Cholesterol [Time frame: Baseline and Week 8]
- Triglycerides [Time frame: Baseline and Week 8]
Secondary outcome measures (12)
- 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]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Turkey (Türkiye) · 1 center
- Haliç University Faculty of Health Sciences — Istanbul
Identifiers
NCT: NCT07718399 · HalicU-SBF-NC-01