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

Abstract

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.

Tapioca Resistant Maltodextrin as a Carbohydrate Source of Oral Nutrition Supplement (ONS) on Metabolic Indicators: A Clinical Trial

“…However, our long-term evaluation of ONS containing TRM found insignificant reduction of total cholesterol and LDL-cholesterol, while HDL-cholesterol and triglyceride were slightly increased. Similarly, a previous study showed that 24-week supplementation of high protein high fiber ONS decreased LDL-cholesterol by 3.25% (from 123 ± 37 mg/dL to 119 ± 36 mg/dL), while HDL-cholesterol increased by 10.26% (from 39 ± 10 mg/dL to 43 ± 10 mg/dL) [34]. Moderate improvement of lipid profile is beneficial to modulate cardiovascular disease (CVDs) risk [35,36].…”

Effects of lifestyle interventions on cardiovascular risk factors in South Asians: a systematic review and meta-analysis

“…Of the 35 included studies (online supplemental table S1), 26 were parallel-arm RCTs,10 32 33 43–45 52–72 and 8 were cluster RCTs 30 34–40. Thirty-one studies were conducted in South Asian countries (20 in India, 5 in Pakistan, 3 in Nepal, 2 in Sri Lanka and 1 in Bangladesh)30 32–40 43–45 53–60 62–64 66–72 and 4 studies were conducted outside of Asia (1 in the USA and 3 in Canada) 10 32 52 61.…”

“…Of the 35 included studies (online supplemental table S1), 26 were parallel-arm RCTs,10 32 33 43–45 52–72 and 8 were cluster RCTs 30 34–40. Thirty-one studies were conducted in South Asian countries (20 in India, 5 in Pakistan, 3 in Nepal, 2 in Sri Lanka and 1 in Bangladesh)30 32–40 43–45 53–60 62–64 66–72 and 4 studies were conducted outside of Asia (1 in the USA and 3 in Canada) 10 32 52 61. Most participants in the studies had at least one major risk factor for CVD such as diabetes,33 54 60 63 67–69 71 dyslipidaemia,43 55 64 hypertension,35 40 44 45 65 66 70 72 obesity53 57 or metabolic syndrome 36 56.…”

“…Thirty-one studies were conducted in South Asian countries (20 in India, 5 in Pakistan, 3 in Nepal, 2 in Sri Lanka and 1 in Bangladesh)30 32–40 43–45 53–60 62–64 66–72 and 4 studies were conducted outside of Asia (1 in the USA and 3 in Canada) 10 32 52 61. Most participants in the studies had at least one major risk factor for CVD such as diabetes,33 54 60 63 67–69 71 dyslipidaemia,43 55 64 hypertension,35 40 44 45 65 66 70 72 obesity53 57 or metabolic syndrome 36 56. Eighteen studies assessed diet alone34 39 43–45 53–59 62 64 67–69 71; 5 studies assessed physical activity alone32 33 60 65 72; and 12 studies assessed a combination of diet and physical activity modifications 10 30 35–38 40 52 61 63 66 70.…”

“…Most participants in the studies had at least one major risk factor for CVD such as diabetes,33 54 60 63 67–69 71 dyslipidaemia,43 55 64 hypertension,35 40 44 45 65 66 70 72 obesity53 57 or metabolic syndrome 36 56. Eighteen studies assessed diet alone34 39 43–45 53–59 62 64 67–69 71; 5 studies assessed physical activity alone32 33 60 65 72; and 12 studies assessed a combination of diet and physical activity modifications 10 30 35–38 40 52 61 63 66 70. The comparator in all of the trials was usual lifestyle/dietary advice, with the exception of three trials in which the comparator was no intervention 37 58 71.…”