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临床试验/NCT07718399
NCT07718399尚未招募不适用

The Effect of Spirulina Supplementation on Metabolic Parameters, Body Composition, Depression, and Sleep Quality in Postmenopausal Women: A Randomized Controlled Trial

Halic University1 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2026年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
66
试验地点
1
主要终点
Fasting Blood Glucose

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Investigator)

盲法说明

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.

入排标准

年龄范围
45 Years 至 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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

结局指标

主要结局

Fasting Blood Glucose

时间窗: Baseline and Week 8

Fasting blood glucose (mg/dL) will be measured at baseline and Week 8 to evaluate the effect of spirulina supplementation.

HbA1c

时间窗: Baseline and Week 8

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

HOMA-IR

时间窗: 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.

Total Cholesterol

时间窗: Baseline and Week 8

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

LDL Cholesterol

时间窗: Baseline and Week 8

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

HDL Cholesterol

时间窗: Baseline and Week 8

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

Triglycerides

时间窗: Baseline and Week 8

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

次要结局

  • 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)
  • Waist-to-Height Ratio(Baseline and Week 8)
  • Body Fat Percentage(Baseline and Week 8)
  • Body Fat Mass(Baseline and Week 8)
  • Total Body Water(Baseline and Week 8)
  • Skeletal Muscle Mass(Baseline and Week 8)
  • The Depression, Anxiety and Stress Scale-21 (DASS-21)(eight weeks)
  • Pittsburgh Sleep Quality Index (PSQI)(eight weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Niran Çomak

DIETITIAN

Halic University

研究点 (1)

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