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Набор скоро начнётся NCT07718399

Spirulina Supplementation in Postmenopausal Women

Без фазы С лечением Postmenopause Overweight

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Spirulina, Placebo.
Кому может быть актуально
Состояния в реестре: Postmenopause, Overweight. Базовые параметры: 45 лет — 65 лет · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Turkey (Türkiye)
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

  • Пищевая добавка Spirulina
    Participants will receive 2 g/day spirulina tablets for 8 weeks.
  • Другое Placebo
    Participants will receive matching placebo tablets for 8 weeks.

Первичные конечные точки

  • Fasting Blood Glucose [Срок оценки: Baseline and Week 8]
  • HbA1c [Срок оценки: Baseline and Week 8]
  • HOMA-IR [Срок оценки: Baseline and Week 8]
  • Total Cholesterol [Срок оценки: Baseline and Week 8]
  • LDL Cholesterol [Срок оценки: Baseline and Week 8]
  • HDL Cholesterol [Срок оценки: Baseline and Week 8]
  • Triglycerides [Срок оценки: Baseline and Week 8]
Вторичные конечные точки (12)
  • Body Weight [Срок оценки: Baseline and Week 8]
  • Body Mass Index [Срок оценки: Baseline and Week 8]
  • Waist Circumference [Срок оценки: Baseline and Week 8]
  • Hip Circumference [Срок оценки: Baseline and Week 8]
  • Mid-Upper Arm Circumference [Срок оценки: Baseline and Week 8]
  • Waist-to-Height Ratio [Срок оценки: Baseline and Week 8]
  • Body Fat Percentage [Срок оценки: Baseline and Week 8]
  • Body Fat Mass [Срок оценки: Baseline and Week 8]
  • Total Body Water [Срок оценки: Baseline and Week 8]
  • Skeletal Muscle Mass [Срок оценки: Baseline and Week 8]
  • The Depression, Anxiety and Stress Scale-21 (DASS-21) [Срок оценки: eight weeks]
  • Pittsburgh Sleep Quality Index (PSQI) [Срок оценки: eight weeks]

Критерии участия

Критерии включения

  • 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.

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Двойное слепое
Основная цель
Лечение

Центры проведения

Turkey (Türkiye) · 1 центр
  • Haliç University Faculty of Health Sciences — Istanbul

Идентификаторы

NCT: NCT07718399 · HalicU-SBF-NC-01

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗