Spirulina Supplementation in Postmenopausal Women

July 18, 2026 updated by: 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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

66

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Turkey (Türkiye)
    • eyüpsultan
      • Istanbul, eyüpsultan, Turkey (Türkiye), 34060
        • Haliç University Faculty of Health Sciences
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 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.
Other: Placebo
Participants will receive matching placebo tablets for 8 weeks.
Active Comparator: Spirulina Group
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and Week 8
HbA1c
Time Frame: 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
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.
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.
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.
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.
Baseline and Week 8
Triglycerides
Time Frame: Baseline and Week 8
Serum triglyceride concentration (mg/dL) will be measured at baseline and Week 8.
Baseline and Week 8

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Body Weight
Time Frame: Baseline and Week 8
Body weight (kg) will be measured at baseline and Week 8.
Baseline and Week 8
Body Mass Index
Time Frame: 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
Time Frame: Baseline and Week 8
Waist circumference (cm) will be measured at baseline and Week 8.
Baseline and Week 8
Hip Circumference
Time Frame: Baseline and Week 8
Hip circumference (cm) will be measured at baseline and Week 8.
Baseline and Week 8
Mid-Upper Arm Circumference
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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)
Time Frame: 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)
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Halic University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

June 1, 2027

Study Registration Dates

First Submitted

June 23, 2026

First Submitted That Met QC Criteria

July 18, 2026

First Posted (Actual)

July 22, 2026

Study Record Updates

Last Update Posted (Actual)

July 22, 2026

Last Update Submitted That Met QC Criteria

July 18, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HalicU-SBF-NC-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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