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Spirulina Supplementation in Postmenopausal Women

2026年7月18日 更新者：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.

研究概览

地位

尚未招聘

条件

干预/治疗

详细说明

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.

研究类型

介入性

注册 (估计的)

66

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

学习地点

  • 土耳其（türkiye）
    • eyüpsultan
      • Istanbul、eyüpsultan、土耳其（türkiye）、34060
        • Haliç University Faculty of Health Sciences
        • 接触：

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

是的

描述

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

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：双倍的

武器和干预

参与者组/臂
干预/治疗
安慰剂比较：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.
其他：Placebo
Participants will receive matching placebo tablets for 8 weeks.
有源比较器：Spirulina Group
It will be administered to the experimental group. The participants will be given 2 g of spirulina tablets per day.
膳食补充剂：Spirulina
Participants will receive 2 g/day spirulina tablets for 8 weeks.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Fasting Blood Glucose
大体时间：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
大体时间：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
大体时间：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
大体时间：Baseline and Week 8
Total cholesterol concentration (mg/dL) will be measured at baseline and Week 8.
Baseline and Week 8
LDL Cholesterol
大体时间：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
大体时间：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
大体时间：Baseline and Week 8
Serum triglyceride concentration (mg/dL) will be measured at baseline and Week 8.
Baseline and Week 8

次要结果测量

结果测量
措施说明
大体时间
Body Weight
大体时间：Baseline and Week 8
Body weight (kg) will be measured at baseline and Week 8.
Baseline and Week 8
Body Mass Index
大体时间：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
大体时间：Baseline and Week 8
Waist circumference (cm) will be measured at baseline and Week 8.
Baseline and Week 8
Hip Circumference
大体时间：Baseline and Week 8
Hip circumference (cm) will be measured at baseline and Week 8.
Baseline and Week 8
Mid-Upper Arm Circumference
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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)
大体时间：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)
大体时间：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

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Halic University

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年7月1日

初级完成 (估计的)

2026年12月1日

研究完成 (估计的)

2027年6月1日

研究注册日期

首次提交

2026年6月23日

首先提交符合 QC 标准的

2026年7月18日

首次发布 (实际的)

2026年7月22日

研究记录更新

最后更新发布 (实际的)

2026年7月22日

上次提交的符合 QC 标准的更新

2026年7月18日

最后验证

2026年7月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • HalicU-SBF-NC-01

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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