Research Article
A Prospective, Open-label, Dietary Intervention to assess the Efficacy, Tolerability and Safety of Celnutra RDM in Remission of Type-2 Diabetes Mellitus in Indian Population
Mondal SK1, Pakhale KL2, Kothari MC3, Mashal AG4, Kashiva RY5, Samant B6, Barbhai MS7, Mahajan M8, Shah VG9, Gada P10, Sikhwal C11, Vyas N12, Pawar A13, Anam Golandaz A14, Deepika VK15, Joshi M16, Shetty Z17, and Nidhi Singh N18
1Senior Dietician, R.K.M.S.P, Kolkata, India.
2Metabolic Physician, Metabol, Mumbai, India.
3Diabetologist and General Physician, Metabol, Mumbai. India.
4Diet Consultant, Metabol, Mumbai, India.
5Director Medicine & Medical Services, HOD - Diabetes & Obesity, Noble hospital, Pune, India.
6Chief dietician, Kokilaben Hospital, Mumbai. India.
7Consultant Clinical Dietitian, Dr.Chonkar’s Chaitanya Heart Clinic, Mumbai, India.
8Clinical Dietitian, Dr.Chonkar’s Chaitanya Heart Clinic, Mumbai. India.
9Clinical Dietician and Diabetes educator, Gut healings, Mumbai, India.
10Senior Dietitian, Vagad medical Center, Mumbai, India.
11Shree Bhagwan Mahaveer Multispeciality, India.
12Clinical Nutritionist, Highland Superspeciality hospital, Mumbai, India.
13Consultant Clinical Nutritionist, Noble hospital, Pune, India.
14Senior Clinical Dietician, Head and Neck Cancer Institute of India, Mumbai
15Senior Clinical Dietitian, Connect and Heal Primary Care Pvt. Ltd, India.
16Senior Clinical Dietitian, Food N U, Nashik, India.
17Clinical Dietician and Diabetes educator, Fortis Hospital, Mumbai, India.
18Clinical Dietitian, Oncoheal, Pune, India.
2Metabolic Physician, Metabol, Mumbai, India.
3Diabetologist and General Physician, Metabol, Mumbai. India.
4Diet Consultant, Metabol, Mumbai, India.
5Director Medicine & Medical Services, HOD - Diabetes & Obesity, Noble hospital, Pune, India.
6Chief dietician, Kokilaben Hospital, Mumbai. India.
7Consultant Clinical Dietitian, Dr.Chonkar’s Chaitanya Heart Clinic, Mumbai, India.
8Clinical Dietitian, Dr.Chonkar’s Chaitanya Heart Clinic, Mumbai. India.
9Clinical Dietician and Diabetes educator, Gut healings, Mumbai, India.
10Senior Dietitian, Vagad medical Center, Mumbai, India.
11Shree Bhagwan Mahaveer Multispeciality, India.
12Clinical Nutritionist, Highland Superspeciality hospital, Mumbai, India.
13Consultant Clinical Nutritionist, Noble hospital, Pune, India.
14Senior Clinical Dietician, Head and Neck Cancer Institute of India, Mumbai
15Senior Clinical Dietitian, Connect and Heal Primary Care Pvt. Ltd, India.
16Senior Clinical Dietitian, Food N U, Nashik, India.
17Clinical Dietician and Diabetes educator, Fortis Hospital, Mumbai, India.
18Clinical Dietitian, Oncoheal, Pune, India.
*Corresponding author:Singh N, Department of Clinical Dietitian, Oncoheal, Pune, Maharastra, India. E-mail Id:
nidhisingh295@gmail.com
Article Information:Submission: 07/02/2025; Accepted: 28/02/2025; Published: 04/03/2025
Copyright: ©2025 Mondal SK, et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
Abstract
Background:Traditional management of Type 2 diabetes emphasizes glycemic control through education and medication, assuming the condition is irreversible. However, it often fails to provide adequate control, highlighting the need for alternative approaches. Lifestyle therapies, including those targeting weight loss and Type 2 diabetes remission, are being explored, with oral nutritional supplements high in protein and low in carbohydrates showing particular promise. The aim was to evaluate the efficacy and safety of Celnutra RDM dietary supplementation in individuals with prediabetes and Type-2 diabetes.
Methods:This was a prospective, open-label, dietary intervention conducted in newly diagnosed participants with prediabetes or Type-2 diabetes. Participants were placed on Celnutra RDM dietary supplementation of 50 g once a day for 90 days. Anthropometric measurements, glycemic profiles, blood pressure and dietary intake were measured at baseline, day-45 and day-90 post intervention. Global overall patient rating responses on the efficacy and safety was obtained post-intervention.
Results:Celnutra RDM supplementation for 90 days resulted in a significant reduction in anthropometric, glycemic profiles and blood pressure. The nutritional supplementation significantly reduced median values of weight, BMI, waist circumference, and waist hip ratio from baseline to post-intervention timepoints (P<0.001). Similarly, the nutritional supplementation significantly reduced median fasting blood glucose, post-prandial blood glucose, and Hb1Ac levels from baseline to post-intervention (P<0.001). Majority participants rated the efficacy and safety profile of the supplementation as good to excellent.
Conclusion:Overall, Celnutra RDM appears to be a viable option for satisfying the unmet need for effective, safe, and well-tolerated nutritional therapy for weight reduction and diabetes remission in prediabetes and Type-2 diabetes.
Methods:This was a prospective, open-label, dietary intervention conducted in newly diagnosed participants with prediabetes or Type-2 diabetes. Participants were placed on Celnutra RDM dietary supplementation of 50 g once a day for 90 days. Anthropometric measurements, glycemic profiles, blood pressure and dietary intake were measured at baseline, day-45 and day-90 post intervention. Global overall patient rating responses on the efficacy and safety was obtained post-intervention.
Results:Celnutra RDM supplementation for 90 days resulted in a significant reduction in anthropometric, glycemic profiles and blood pressure. The nutritional supplementation significantly reduced median values of weight, BMI, waist circumference, and waist hip ratio from baseline to post-intervention timepoints (P<0.001). Similarly, the nutritional supplementation significantly reduced median fasting blood glucose, post-prandial blood glucose, and Hb1Ac levels from baseline to post-intervention (P<0.001). Majority participants rated the efficacy and safety profile of the supplementation as good to excellent.
Conclusion:Overall, Celnutra RDM appears to be a viable option for satisfying the unmet need for effective, safe, and well-tolerated nutritional therapy for weight reduction and diabetes remission in prediabetes and Type-2 diabetes.
Keywords:Nutrition; Dietary; Glycemic; Weight loss; Celnutra; Prediabetes; Type-2 diabetes