Spirulina Supplementation in Postmenopausal Women
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age45-65
SponsorHalic University
About this 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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Spirulina
Dietary supplementParticipants will receive 2 g/day spirulina tablets for 8 weeks.
Placebo
Other interventionParticipants will receive matching placebo tablets for 8 weeks.
Treatment groups
66 Participants
are divided into 2 treatment groupsGroup A: Placebo GroupPlacebo comparator 1 intervention
Group B: Spirulina GroupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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 82
HbA1c
HbA1c (%) will be measured at baseline and Week 8 to assess long-term glycemic control.
Time frame
Baseline and Week 83
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 84
Total Cholesterol
Total cholesterol concentration (mg/dL) will be measured at baseline and Week 8.
Time frame
Baseline and Week 8Secondary outcomes
1
Body Weight
Body weight (kg) will be measured at baseline and Week 8.
Time frame
Baseline and Week 82
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 83
Waist Circumference
Waist circumference (cm) will be measured at baseline and Week 8.
Time frame
Baseline and Week 84
Hip Circumference
Hip circumference (cm) will be measured at baseline and Week 8.
Time frame
Baseline and Week 8Sponsors and contacts
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Source ClinicalTrials.gov
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