Spirulina Supplementation in Postmenopausal Women

NCT07718399 | Not Yet Recruiting

• 1 other identifier: HalicU-SBF-NC-01
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Postmenopause; Overweight

Keywords

spirulina; depression; postmenopause; overweight; Sleep Quality; lipid profile; blood glucose; metabolic parameters

Outcome Measures

Primary Outcomes (7)

• Fasting Blood Glucose

  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

  HbA1c (%) will be measured at baseline and Week 8 to assess long-term glycemic control.

  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.

  Baseline and Week 8

• Total Cholesterol

  Total cholesterol concentration (mg/dL) will be measured at baseline and Week 8.

  Baseline and Week 8

• LDL Cholesterol

  Low-density lipoprotein (LDL) cholesterol concentration (mg/dL) will be measured at baseline and Week 8.

  Baseline and Week 8

• HDL Cholesterol

  High-density lipoprotein (HDL) cholesterol concentration (mg/dL) will be measured at baseline and Week 8.

  Baseline and Week 8

• Triglycerides

  Serum triglyceride concentration (mg/dL) will be measured at baseline and Week 8.

  Baseline and Week 8

Secondary Outcomes (12)

• Body Weight

  Baseline and Week 8

• Body Mass Index

  Baseline and Week 8

• Waist Circumference

  Baseline and Week 8

• Hip Circumference

  Baseline and Week 8

• Mid-Upper Arm Circumference

  Baseline and Week 8

Study Arms (2)

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.

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.

Dietary Supplement: Spirulina

Interventions

Spirulina DIETARY_SUPPLEMENT

Participants will receive 2 g/day spirulina tablets for 8 weeks.

Spirulina Group

Placebo OTHER

Participants will receive matching placebo tablets for 8 weeks.

Placebo Group

Eligibility Criteria

• Age: 45 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Halic University: lead

Study Sites (1)

Haliç University Faculty of Health Sciences

Istanbul, eyüpsultan, 34060, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Overweight; Depression; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Central Study Contacts

Niran ÇOMAK, Dietitian

CONTACT

905432670224; niran_cmk@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: While the experimental group will be given spirulina, the control group will be given a placebo; this group assignment will be carried out by a researcher who is unaware of the assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: DIETITIAN

Model Details: two groups with a control group and an experimental group

Study Record Dates

• First Submitted: June 23, 2026
• First Posted: July 22, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: July 22, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)