Effect of Moringa leaves on Bone Mineral Density of Osteopenia patients- A randomized clinical trial
试验速览
- 阶段
- Phase 3 4
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Correction of Osteopenia by including sundried moringa leaves and powder with vitamin d2 rich diet.
研究概览
简要总结
| Osteopenia |
| means abnormal bone density but not as low as osteoporosis. (Karaguzel, G., |
| & Holick, M. F. (2010). It is a condition when bones start to lose mass, |
| also bone mineral density (BMD) measures lower than average, but not as low |
| as in osteoporosis. (TO, O. G. What is osteopenia?). |
World Health Organization is defined osteopenia by bone densitometry as a T score −1 to −2.5. There are so many reasons that cause osteopenia including calcium and vitamin D deficiency and inactivity (Karaguzel, G., & Holick, M. F. (2010).
Still, with osteopenia, the bones lose calcium and become porous and weak, making more vulnerable to fractures. Osteopenia does not cause symptoms, but it is a precursor to osteoporosis. While it doesn’t always develop into osteoporosis, it’s important to address osteopenia immediately to prevent further decline in bone mass. (TO, O. G. What is osteopenia?).
Nearly one out of two adults has osteopenia and one out of five adults has osteoporosis. Osteoporosis prevalence was higher in the women and in the elderly. Nearly one out of three women in postmenopausal age group has osteoporosis. Considering the significant prevalence of low BMD, there is a need to increase the awareness about bone health in general population. (Babhulkar, S., & Seth, S. (2021).
Worldwide, it is estimated that 1 in 3 women above the age of 50 will experience osteoporotic fractures, as well as 1 in 5 men.
India with a population of 1.2 billion people is the second most populated country in the world with approximately 10% of population (more than 100 million) over 50 years of age. In 2013, sources estimate that 50 million people in India are either osteoporotic (T-score lower than-2.5) or have low bone mass (T-score between-1.0 and-2.5). Studies indicate that osteoporosis and osteopenia or low bone mass may occur at a relatively younger age in Indian population (Kadam, N. S.,et al. 2018).
Bone is a complex cellular tissue. It contains approximately 70% mineral and 30% organic constituents. The mineral phase consists of about 95% hydroxyapatite, a highly organized crystal of calcium and phosphorous, and other ions (such as sodium, magnesium, fluoride, and strontium). Bone mass and density are determined by various concurrent factors, such as genetics, hormones, physical activity and nutrition. Among the various nutrients, calcium and vitamin D have proven their efficacy for normal bone growth and development in children and adolescents and for the maintenance of bone mineral loss in postmenopausal women. An optimal calcium intake is necessary for bone health at all stages of life. Dietary requirements for calcium are determined by the need for bone development and bone maintenance, which vary throughout life, being higher during childhood and adolescence, during pregnancy and lactation, and in the elderly (Vannucci, L., et al. 2018).
Moringa oleifera Lam is a multipurpose and exceptionally nutritious vegetable tree with a variety of potential uses and native to Indian subcontinent. Tree occupies important position in the Indian vegetable industry. Almost all parts of the plant contain some remarkable medicinal and pharmaceutical properties and can be consumed for long time. It is used in more than 80 countries to relieve vitamin and mineral deficiencies, beneficial in cardiovascular system, blood-glucose levels, malignancy by neutralizing free radicals, immune system of the body, in mental alertness, improvement in eyesight, general weakness, lactating mothers, menopause, bone strength, and depression. In India, it is grown for its leaves, flowers, and pods. Its pod is a prevalent vegetable in south part of India. The leaves of Moringa tree possess remarkable nutritional and medicinal qualities, they are rich source of minerals and vitamins and exhibits antioxidant activity and phenolic compound like quercetin and kaempferol. Fresh leaves of Moringa are a good source of carotenoids with pro-vitamin A. They contain high amount of vitamin C, vitamin A, Calcium, which builds strong bones and teeth and helps prevent osteoporosis; Potassium and Proteins, the basic building blocks of all our body cells , contains all of the essential amino acids in a good proportion, also contains argenine and histidine two amino acids especially important for infants, who are unable to make enough protein for their growth requirements.
Different preparation from Moringa leaves, flowers, and fruits are used in Indian subcontinent for various purposes. Due to high nutritional value, it is a popular vital food source against PEM, which is quite common in under developed and developing countries.
The micro-nutrient content is even more in dried leaves. Therefore it is necessary to increase the utilization of Moringa leaves consumption by the different communities. It should be consumed either fresh or dry. Dried leaves can be stored for a long time and can be used regularly.
Many companies across the world manufacturing various products of Moringa leaves such as Moringa Tea, Moringa Tablets, Moringa Capsules, Moringa leaf Powder, Moringa Soaps and Moringa Face wash. Leaves can be eaten fresh, cooked, or stored as dried powder for many months without refrigeration, and reportedly without loss of nutritional value. Leaves were also used for food fortification Spoonful of the powder can then be added to baby food, soups, and vegetables, adding nutrition but not changing the taste. In this way, Moringa leaves will be ready available to improve nutritional intake on a daily basis (Singh, L., Singh, J., & Singh, J. (2019), (Mishra, S. P., Singh, P., & Singh, S. (2012).
Thus we have seen Moringa leaves are rich in many nutrients, also available round the year at all places in India, so we will use this nutrient dense leaves to osteopenia patients and will check whether its intervention is beneficial effect on osteopenia or not.
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)(—)
- 性别
- All
入选标准
- •Confirmed diagnosed Osteopenia patients by DEXA scan (T score -1 to -2.5), male or female patients of 18-60 years.
排除标准
- •Chronic Kidney disease (CKD)
- •Intestinal mal absorption disorders like colitis, IBS etc.
结局指标
主要结局
Correction of Osteopenia by including sundried moringa leaves and powder with vitamin d2 rich diet.
时间窗: 3 months
次要结局
- To check symptomatic relief occurred due to Osteopenia like(3 months)
研究者
Dr Swati Khartode
Vishwaraj Hospital
