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Spirulina Supplementation in Postmenopausal Women

18. juli 2026 opdateret af: Niran Çomak, Halic University

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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

66

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Tyrkiet (Türkiye)
    • eyüpsultan
      • Istanbul, eyüpsultan, Tyrkiet (Türkiye), 34060
        • Haliç University Faculty of Health Sciences
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ja

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Placebo komparator: Placebo Group
It will be administered to the control group. Tablets containing starch and food coloring will be administered at a dose of 2 g/day.
Andet: Placebo
Participants will receive matching placebo tablets for 8 weeks.
Aktiv komparator: Spirulina Group
It will be administered to the experimental group. The participants will be given 2 g of spirulina tablets per day.
Kosttilskud: Spirulina
Participants will receive 2 g/day spirulina tablets for 8 weeks.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Fasting Blood Glucose
Tidsramme: Baseline and Week 8
Fasting blood glucose (mg/dL) will be measured at baseline and Week 8 to evaluate the effect of spirulina supplementation.
Baseline and Week 8
HbA1c
Tidsramme: Baseline and Week 8
HbA1c (%) will be measured at baseline and Week 8 to assess long-term glycemic control.
Baseline and Week 8
HOMA-IR
Tidsramme: 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.
Baseline and Week 8
Total Cholesterol
Tidsramme: Baseline and Week 8
Total cholesterol concentration (mg/dL) will be measured at baseline and Week 8.
Baseline and Week 8
LDL Cholesterol
Tidsramme: Baseline and Week 8
Low-density lipoprotein (LDL) cholesterol concentration (mg/dL) will be measured at baseline and Week 8.
Baseline and Week 8
HDL Cholesterol
Tidsramme: Baseline and Week 8
High-density lipoprotein (HDL) cholesterol concentration (mg/dL) will be measured at baseline and Week 8.
Baseline and Week 8
Triglycerides
Tidsramme: Baseline and Week 8
Serum triglyceride concentration (mg/dL) will be measured at baseline and Week 8.
Baseline and Week 8

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Body Weight
Tidsramme: Baseline and Week 8
Body weight (kg) will be measured at baseline and Week 8.
Baseline and Week 8
Body Mass Index
Tidsramme: Baseline and Week 8
Body mass index (BMI, kg/m²) will be calculated from measured height and body weight and assessed at baseline and Week 8.
Baseline and Week 8
Waist Circumference
Tidsramme: Baseline and Week 8
Waist circumference (cm) will be measured at baseline and Week 8.
Baseline and Week 8
Hip Circumference
Tidsramme: Baseline and Week 8
Hip circumference (cm) will be measured at baseline and Week 8.
Baseline and Week 8
Mid-Upper Arm Circumference
Tidsramme: Baseline and Week 8
Mid-upper arm circumference (cm) will be measured at baseline and Week 8.
Baseline and Week 8
Waist-to-Height Ratio
Tidsramme: Baseline and Week 8
Waist-to-height ratio will be calculated using waist circumference and height measurements obtained at baseline and Week 8.
Baseline and Week 8
Body Fat Percentage
Tidsramme: Baseline and Week 8
Body fat percentage (%) will be assessed using bioelectrical impedance analysis at baseline and Week 8.
Baseline and Week 8
Body Fat Mass
Tidsramme: Baseline and Week 8
Body fat mass (kg) will be assessed using bioelectrical impedance analysis at baseline and Week 8.
Baseline and Week 8
Total Body Water
Tidsramme: Baseline and Week 8
Total body water (kg) will be assessed using bioelectrical impedance analysis at baseline and Week 8.
Baseline and Week 8
Skeletal Muscle Mass
Tidsramme: Baseline and Week 8
Skeletal muscle mass (kg) will be assessed using bioelectrical impedance analysis at baseline and Week 8.
Baseline and Week 8
The Depression, Anxiety and Stress Scale-21 (DASS-21)
Tidsramme: eight weeks
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.
eight weeks
Pittsburgh Sleep Quality Index (PSQI)
Tidsramme: eight weeks
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.
eight weeks

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Halic University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. juli 2026

Primær færdiggørelse (Anslået)

1. december 2026

Studieafslutning (Anslået)

1. juni 2027

Datoer for studieregistrering

Først indsendt

23. juni 2026

Først indsendt, der opfyldte QC-kriterier

18. juli 2026

Først opslået (Faktiske)

22. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

22. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

18. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • HalicU-SBF-NC-01

Plan for individuelle deltagerdata (IPD)

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