Title: A Medical Nutritional Supplement Improves BMI, Hemoglobin, Fatigue levels in female anemic patients.

Abstract:

OBJECTIVE: The aim of this study was to determine the effect of 3 months consumption of medical nutrition supplement (MNS) in adult anemic females.
BACKGROUND: Globally, anemia affects 1.62 billion people, whereas in India 53.2% of non-pregnant women and 50.4% of pregnant women were found to be anemic in 2018, as per the NFHS. Proper balanced daily nutrition is important for women, which includes adequate levels of essential high-quality proteins, amino acids and complex carbohydrates to help meet adult nutritional needs (1,2). Therefore, in the present study, the short-term effects of MNS rich in proteins, hemo-nutrients and biotin in anemic women were studied.
DESIGN: This was a retrospective observational study where MNS (MaxvidaTM) was given to 226 anemic female subjects between 1st March to 30th April 2019 and evaluated for their clinical data (age, weight, and BMI), Modified Fatigue Impact Scale (MFIS) and hand-held dynamometry (HHD) at 1, 2 and 3 months.  
RESULTS: The mean (SD) age of patients was 31.1 (8.9) years in this study. A significant improvement in BMR was observed from baseline 21.7±0.3 to 22.6±035 at 3 months (p=0.013). Weight was found to increase from baseline 51.3±0.7 to 53.3±0.6 and 53.9±0.6 kg at both 2nd and 3rd months, respectively (p = 0.001). Statistically significant increase in Hb levels was observed from baseline 9.0±0.1 to 11.0±0.1 at 3 months (p=0.001) due to MaxvidaTM intake. There was a significant reduction in MFIS score from baseline 51.1±1.1 to 28.9±1.3 at 3 months (p=0.0001), and improvement in HHD score from 17.3±0.4 to 22.0±0.5 at 3 months (p = 0.001). No serious adverse effects were noticed during consumption.
DISCUSSION: 
Anemic condition in females is increasing throughout the world as the population in most of the countries continues to age, impacting their BMI. This study evaluated the efficacy and safety pattern of consuming   MaxvidaTM. Overall, Hb levels increased by 2.0% (from 9.0 to 11.0) at the end of 3 months with overall statistical increase in BMR. There was also statistical increase in HHD showing increase in muscular response and improvement from fatigue. 
Conclusion: MNS MaxvidaTM was found to be efficacious in improving the anemic conditions in female subjects with no deleterious effects.

Biography:

Pharmacovigilance, Clinical Trials, Regulatory Affairs, Medicine, Healthcare, Clinical Research, Oncology, Diabetes, Medical Writing, Cardiology, Medical Affairs, Pharmacology, Pharmaceutical Industry, Urology, GCP, ICH-GCP, Clinical Development, Pharmaceutics, Life Sciences, CRO, Product Launch, SOP, Regulatory Submissions, Ich Gcp, Strategic Planning

Title: Medical Nutritional Supplement Improves Fatigue levels and muscle strength in adults complaining of generalized weakness and fatigue

Abstract:

OBJECTIVE: The aim of this study was to determine the effect of 3 months consumption of medical nutrition supplement (MNS) in adults complaining of generalized weakness and fatigue.
BACKGROUND: Aging is accompanied by substantial changes in body composition which affects both physical abilities and appearance. After reaching a peak in early adult years, skeletal muscle mass and strength gradually decline 
(1). Despite its high prevalence, fatigue remains an often-neglected symptom. It is usually defined as a state related with the weakening and/or depletion of the individual’s physical and/or mental resources. Fatigue is strongly associated with poor physical performance 
(2). Proper balanced daily nutrition is vital for adults, which includes adequate levels of essential high-quality proteins, amino acids and complex carbohydrates to help meet adult nutritional needs (3,4). Therefore, in the present study, the short-term effects of MNS rich in proteins, hemo-nutrients and biotin in adults complaining of generalized weakness and fatigue were studied.
DESIGN: This was a retrospective observational study where MNS (MaxvidaTM) was given to 289 subjects (aged 18-45 years) between 1st March to 30th April 2019 and evaluated for their clinical data (age, weight, and BMI), Modified Fatigue Impact Scale (MFIS) and hand-held dynamometry (HHD) at 1, 2 and 3 months.  
RESULTS: The mean age of patients was 33.5 years in this study. A significant improvement in BMI was observed from baseline 22.3±0.3 to 22.8±0.2 at 3 months. Weight was found to increase from baseline 55.5±0.7 kg to 57.7±0.6 kg at 3rd months (p = 0.017). Statistically significant increase in Hb levels was observed from baseline 9.6±0.1 to 11.6±0.1 at 3 months (p=0.0001) due to MNS intake. There was a significant reduction in MFIS score from baseline 48.8±0.9 to 31.4±1.2 at 3 months (p=0.0001), and improvement in HHD score from 21.6±0.5 to 26.4±0.5 at 3 months (p = 0.001). No serious adverse effects were noticed during consumption.
DISCUSSION: Poor nutritional status and advancing age can be the contributing factor of fatigue and decrease muscular strength. This study evaluated the efficacy and safety pattern of consuming MNS. Overall, at 3 months, there was a significant reduction in MFIS score by 17.4 points (p=0.0001), and improvement in HHD score by 4.8 (p = 0.001), showing increase in muscular response and improvement from fatigue. Hb levels also increased by 2.0% at the end of 3 months with overall statistical increase in BMR.
Conclusion: MNS used in the study was found to be efficacious in improving the fatigue levels and muscle strength in subjects with no deleterious effects

Biography:

Pharmacovigilance, Clinical Trials, Regulatory Affairs, Medicine, Healthcare, Clinical Research, Oncology, Diabetes, Medical Writing, Cardiology, Medical Affairs, Pharmacology, Pharmaceutical Industry, Urology, GCP, ICH-GCP, Clinical Development, Pharmaceutics, Life Sciences, CRO, Product Launch, SOP, Regulatory Submissions, Ich Gcp, Strategic Planning