Analysing the efficacy of Amaranthus in modulating metabolic hormones and reproductive hormones and their health-related behavioural changes in perimenopausal and postmenopausal women.
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 128
- 试验地点
- 1
研究概览
简要总结
This study aims to evaluate the efficacy of Amaranthus (Amaranthus cruentus) as a functional food intervention to modulate metabolic and reproductive hormones and improve health-related behaviours, including sleep quality, in peri- and postmenopausal women. Menopause is associated with hormonal imbalance, visceral adiposity, metabolic dysfunction, vasomotor symptoms, mood disturbances, and sleep disruption. While Hormone Replacement Therapy (HRT) is commonly used, its long-term risks and cost limit acceptability. Amaranth, a nutrient-dense pseudocereal rich in essential amino acids, minerals, antioxidants, and bioactive phytochemicals, may offer a safe and cost-effective dietary alternative to support hormonal regulation and metabolic health. This quasi-experimental study will include 128 women aged 40–65 years, screened and categorized into perimenopausal and postmenopausal groups based on menstrual history and FSH levels. Participants in each stage will be divided into intervention and control groups. A newly developed amaranth-based functional food product will be supplemented to the intervention group for 16 weeks. Pre- and post-intervention assessments will measure anthropometry, dietary intake, metabolic hormones (insulin, leptin, ghrelin, adiponectin, cortisol), reproductive hormones (estrogen, progesterone, FSH, LH), and sleep quality using the Pittsburgh Sleep Quality Index (PSQI). Compliance will be monitored. Product development includes nutrient profiling, phytochemical analysis (HPLC, GC–MS), sensory evaluation, and shelf-life testing. The study will determine whether daily amaranth supplementation improves hormonal balance and associated health behaviours in peri- and postmenopausal women, providing evidence for a natural, affordable, and culturally acceptable alternative or adjunct to HRT.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 40.00 Year(s) 至 65.00 Year(s)(—)
- 性别
- Female
入选标准
- •To include women aged between 40–65 years and having a BMI between 18.5 – 40 kg/m².
- •To include those women who are willing to follow-up for a minimum of 6 months.
排除标准
- •To exclude women who have a history of metabolic disorders such as cardiovascular, Type 2 diabetes mellitus, renal and liver disorders.
- •To exclude women who are smoking, alcohol, or drug.
- •To exclude women who are using hormonal supplements, steroids, anti-obesity medications, or sleep medications.
- •To exclude women using hormone replacement therapy (HRT) or with hysterectomy, Thyroid dysfunction (Hypothyroidism) will be excluded unless vasomotor symptoms are present.
- •To exclude women who have a history of complete absence of menstruation for more than 5 to 10 years.
- •To exclude women who are known to have an allergy to certain grains or seeds.
研究者
Charu Gupta
