PMID- 33953977 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20220422 IS - 2090-0724 (Print) IS - 2090-0732 (Electronic) IS - 2090-0724 (Linking) VI - 2021 DP - 2021 TI - Effect of a High-Protein High-Fibre Nutritional Supplement on Lipid Profile in Overweight/Obese Adults with Type 2 Diabetes Mellitus: A 24-Week Randomized Controlled Trial. PG - 6634225 LID - 10.1155/2021/6634225 [doi] LID - 6634225 AB - BACKGROUND: Foods rich in protein and dietary fibre could potentially improve lipid profile in overweight or obese diabetic patients with dyslipidemia and, thereby, mitigate their risk of cardiovascular disease (CVD). In this study, the effect of providing high-protein high-fibre (HPHF) nutritional supplement in addition to standard care of type 2 diabetes mellitus (T2DM) on lipid profile was evaluated. METHODS: In this open-label, parallel-arm, prospective, randomized study, a total of 100 overweight/obese participants with T2DM were randomized to either an intervention group (25 g HPHF nutritional supplement given twice daily along with a standard care of T2DM) or a control group (standard care of T2DM) for 24 weeks. Change from baseline in lipid parameters such as total cholesterol (TChol), high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C), and triglycerides (TG) was assessed between the intervention and control group at week 12 and week 24. Participant compliance was assessed using the dietary 24-hour recall. Statistical analysis was performed to assess the main effects on within- and between-group changes from baseline to end of 24 weeks. RESULTS: Participants in the HPHF nutritional supplement group showed a statistically significant improvement in HDL-C levels by the end of 24 weeks (p=0.04) and a significant increase in protein and total dietary fibre intake (p=0.002 and p=0.00, respectively) compared to the control group. The TChol/HDL-C ratio was significantly lower (p=0.03) in the HPHF group from baseline to 24 weeks. CONCLUSION: Twice-daily consumption of a HPHF nutritional supplement significantly improved HDL-C levels. Inclusion of the HPHF supplement would be a useful effective aid for managing dyslipidemia in overweight/obese individuals with T2DM. CI - Copyright (c) 2021 Rachana Bhoite et al. FAU - Bhoite, Rachana AU - Bhoite R AUID- ORCID: 0000-0001-5291-6799 AD - Dr. Reddy's Laboratories Pvt Ltd., Ameerpet, Hyderabad, India. FAU - Chandrasekaran, Anitha AU - Chandrasekaran A AD - Department of Diabetology, Dr. Mohan's Diabetes Specialities Centre, Chennai, India. FAU - Pratti, Varalakshmi Lalithya AU - Pratti VL AD - Dr. Reddy's Laboratories Pvt Ltd., Ameerpet, Hyderabad, India. FAU - Satyavrat, Vinita AU - Satyavrat V AD - Dr. Reddy's Laboratories Pvt Ltd., Ameerpet, Hyderabad, India. FAU - Aacharya, Shivani AU - Aacharya S AD - Dr. Reddy's Laboratories Pvt Ltd., Ameerpet, Hyderabad, India. FAU - Mane, Amey AU - Mane A AD - Dr. Reddy's Laboratories Pvt Ltd., Ameerpet, Hyderabad, India. FAU - Mehta, Suyog AU - Mehta S AD - Dr. Reddy's Laboratories Pvt Ltd., Ameerpet, Hyderabad, India. FAU - Kale, Ravindra Machhindra AU - Kale RM AD - Dr. Reddy's Laboratories Pvt Ltd., Ameerpet, Hyderabad, India. FAU - Nagamuthu, Gayathri AU - Nagamuthu G AD - Department of Foods, Nutrition & Dietetics Research, Madras Diabetes Research Foundation, Chennai, India. FAU - Selvaraj, Sasikala AU - Selvaraj S AD - Department of Foods, Nutrition & Dietetics Research, Madras Diabetes Research Foundation, Chennai, India. FAU - Rajagopal, Gayathri AU - Rajagopal G AD - Department of Foods, Nutrition & Dietetics Research, Madras Diabetes Research Foundation, Chennai, India. FAU - Vasudevan, Sudha AU - Vasudevan S AD - Department of Foods, Nutrition & Dietetics Research, Madras Diabetes Research Foundation, Chennai, India. FAU - Shanmugam, Shobana AU - Shanmugam S AD - Department of Foods, Nutrition & Dietetics Research, Madras Diabetes Research Foundation, Chennai, India. FAU - Mohan, Anjana Ranjit AU - Mohan AR AD - Department of Diabetology, Dr. Mohan's Diabetes Specialities Centre, Chennai, India. AD - Department of Foods, Nutrition & Dietetics Research, Madras Diabetes Research Foundation, Chennai, India. FAU - Unnikrishnan, Ranjit AU - Unnikrishnan R AD - Department of Diabetology, Dr. Mohan's Diabetes Specialities Centre, Chennai, India. AD - Department of Foods, Nutrition & Dietetics Research, Madras Diabetes Research Foundation, Chennai, India. FAU - Krishnaswamy, Kamala AU - Krishnaswamy K AD - Department of Foods, Nutrition & Dietetics Research, Madras Diabetes Research Foundation, Chennai, India. FAU - Mohan, Viswanathan AU - Mohan V AD - Department of Diabetology, Dr. Mohan's Diabetes Specialities Centre, Chennai, India. AD - Department of Foods, Nutrition & Dietetics Research, Madras Diabetes Research Foundation, Chennai, India. LA - eng PT - Journal Article DEP - 20210415 PL - United States TA - J Nutr Metab JT - Journal of nutrition and metabolism JID - 101526296 PMC - PMC8064784 COIS- The authors report no conflicts of interest. EDAT- 2021/05/07 06:00 MHDA- 2021/05/07 06:01 PMCR- 2021/04/15 CRDT- 2021/05/06 07:05 PHST- 2020/11/27 00:00 [received] PHST- 2021/02/19 00:00 [revised] PHST- 2021/04/01 00:00 [accepted] PHST- 2021/05/06 07:05 [entrez] PHST- 2021/05/07 06:00 [pubmed] PHST- 2021/05/07 06:01 [medline] PHST- 2021/04/15 00:00 [pmc-release] AID - 10.1155/2021/6634225 [doi] PST - epublish SO - J Nutr Metab. 2021 Apr 15;2021:6634225. doi: 10.1155/2021/6634225. eCollection 2021.