Research Article

A Complementary Therapy with Whey Protein in Diabetes: A Double-Blind Randomized Controlled Clinical Trial


Type 2 diabetes (T2DM) and its complications can cause severe morbidity and mortality. The researchers and clinicians’ attention has been toward finding the efficient treatment for T2DM to decrease its heavy burden on the people and countries. Whey protein (WP) is a known glucose-lowering treatment of traditional Persian medicine. This randomized controlled clinical trial aimed to evaluate the efficacy of the WP on the improvement of the glycemic index of the patients with T2DM in Fars, Fasa, Iran. A total of 58 people with T2DM met the inclusion criteria and were randomly assigned to one of two groups: intervention or placebo. For 12 weeks, they were given 1 sachet of WP or 1 sachet of placebo. Before and after the trial, fasting blood sugar, lipid profile, and liver enzymes were tested. Finally, 35 patients completed the study (18 in the whey group and 17 in the placebo group). The mean ± standard deviation of age, BMI, and the disease duration in placebo group were: 52.1±9.2 years, 26.8±3.9 kg/m2 and 102.9±67.7 months and in WP group were 51.2±8.2 years, 25.7±3.7 kg/m2 and 74.2±51.1 months. There were no significant differences among the study groups at the beginning (P>0.05). Meanwhile, the WP and placebo groups were the same by means of the amount of anti-diabetic drugs that participants consumed (P=0.242). After 12 weeks: the fasting blood sugar (FBS) and hemoglobin A1C amounts showed important decreases in the WP group compared to its starting point (P=0.011 and P=0.001 respectively), while in the placebo group, there was no significant difference in this matter (P>0.05).  No severe complications were reported in both groups. In conclusion, we found that whey protein would be a promising complementary therapy to control hyperglycemia in the patients with T2DM.

Association AD. Classification and diagnosis of diabetes. Diabetes care 2015;38:S8-S16.

Roglic G. WHO global report on diabetes: a summary. Int J Noncommun Dis 2016;1:13.

Dugani SB, Mielke MM, Vella A. Burden and management of type 2 diabetes in rural United States. Diabetes Metab Res Rev 2021;37:e3410.

Nauck MA, Wefers J, Meier JJ. Treatment of type 2 diabetes: challenges, hopes, and anticipated successes. Lancet Diabetes Endocrinol 2021;9:525-544.

Bailey CJ, Day C. Treatment of type 2 diabetes: future approaches. Br Med Bull 2018;126:123-137.

Taylor SI, Yazdi ZS, Beitelshees AL. Pharmacological treatment of hyperglycemia in type 2 diabetes. J Clin Invest 2021;131:e142243.

Liu Q, Liu S, Gao L, Sun S, Huan Y, et al. Anti-diabetic effects and mechanisms of action of a Chinese herbal medicine preparation JQ-R in vitro and in diabetic KKAy mice. Acta Pharm Sin B 2017;7:461-469.

Sami W, Ansari T, Shafique Butt N, Rashid Ab Hamid M. Effect of diet on type 2 diabetes mellitus: A review. Int J Health Sci 2017;11:65-71.

Naghizadeh A, Salamat M, Hamzeian D, Akbari S, Rezaeizadeh H, et al. IrGO: Iranian traditional medicine General Ontology and knowledge base. J Biomed Semantics 2021;12:9.

Jakubowicz D, Tsameret S, Landau Z, Wainstein J. Role of the Synchronization of Circadian Clock by Meal-Timing in Obesity and Type 2 Diabetes. In Cellular and Biochemical Mechanisms of Obesity. 2021, Springer pp 337-351.

Pasin G, Comerford KB. Dairy foods and dairy proteins in the management of type 2 diabetes: a systematic review of the clinical evidence. Adv Nutr 2015;6:245-259.

Mortensen LS, Holmer-Jensen J, Hartvigsen ML, Jensen VK, Astrup A, et al. Effects of different fractions of whey protein on postprandial lipid and hormone responses in type 2 diabetes. Eur J Clin Nutr 2012;66:799-805.

Jakubowicz D, Wainstein J, Landau Z, Ahren B, Barnea M, et al. High-energy breakfast based on whey protein reduces body weight, postprandial glycemia and HbA1C in Type 2 diabetes. J Nutr Biochem 2017;49:1-7.

Wu T, Little TJ, Bound MJ, Borg M, Zhang X, et al. A protein preload enhances the glucose-lowering efficacy of vildagliptin in type 2 diabetes. Diabetes Care 2016;39:511-517.

Jakubowicz D, Froy O, Ahren B, Boaz M, Landau Z, et al. Incretin, insulinotropic and glucose-lowering effects of whey protein pre-load in type 2 diabetes: a randomised clinical trial. Diabetologia 2014;57:1807-1811.

Ma J, Stevens JE, Cukier K, Maddox AF, Wishart JM, et al. Effects of a protein preload on gastric emptying, glycemia, and gut hormones after a carbohydrate meal in diet-controlled type 2 diabetes. Diabetes Care 2009;32:1600-1602.

Clifton PM, Galbraith C, Coles L. Effect of a low dose whey/guar preload on glycemic control in people with type 2 diabetes-a randomised controlled trial. Nutr J 2014;13:1-5.

Aydın B, Oğuz A, Şekeroğlu V, Şekeroğlu ZA. Whey protein protects liver mitochondrial function against oxidative stress in rats exposed to acrolein. Arh Hig Rada Toksikol 2022; 73:200-206.

Derosa G, D'Angelo A, Maffioli P. Change of some oxidative stress parameters after supplementation with whey protein isolate in patients with type 2 diabetes. Nutrition 2020; 73:110700.

Babault N, Païzis C, Deley G, Guérin-Deremaux L, Saniez M-H, et al. Pea proteins oral supplementation promotes muscle thickness gains during resistance training: a double-blind, randomized, Placebo-controlled clinical trial vs. Whey protein. J Int Soc Sports Nutr 2015;12:3.

Morcillo S, Atencia JA, Martín F, de la Torre AO, Bilbao JR, et al. Consumption of cows’ milk is associated with lower risk of type 2 diabetes mellitus. A cross-sectional study. Int Dairy J 2012;26:162-165.

Jiang B, Wang L, Wang M, Wu S, Wang X, et al. Direct separation and purification of α‐lactalbumin from cow milk whey by aqueous two‐phase flotation of thermo‐sensitive polymer/phosphate. J Sci Food Agric 2021;101:4173-4182.

Teixeira FJ, Santos HO, Howell SL, Pimentel GD. Whey protein in cancer therapy: A narrative review. Pharmacol Res 2019;144:245-256.

Blachier F, Lancha Jr AH, Boutry C, Tomé D. Alimentary proteins, amino acids and cholesterolemia. Amino Acids 2010;38:15-22.

Liu L, Zhang D-M, Wang M-X, Fan C-Y, Zhou F, et al., The adverse effects of long-term l-carnitine supplementation on liver and kidney function in rats. Hum Exp Toxicol 2015;34: 1148-1161.

Vasconcelos QDJS, Bachur TPR, Aragão GF. Whey protein supplementation and its potentially adverse effects on health: a systematic review. Appl Physiol Nutr Metab 2021; 46:27-33.

Devries MC, Sithamparapillai A, Brimble KS, Banfield L, Morton RW, et al. Changes in kidney function do not differ between healthy adults consuming higher-compared with lower-or normal-protein diets: a systematic review and meta-analysis. J Nutr 2018;148: 1760-1775.

Oguntibeju OO. Type 2 diabetes mellitus, oxidative stress and inflammation: examining the links. Int J Physiol Pathophysiol Pharmacol 2019;11:45.

Halim M, Halim A. The effects of inflammation, aging and oxidative stress on the pathogenesis of diabetes mellitus (type 2 diabetes). Clin Res Rev 2019;13:1165-1172.

Zatterale F, Longo M, Naderi J, Raciti GA, Desiderio A, et al. Chronic adipose tissue inflammation linking obesity to insulin resistance and type 2 diabetes. Front Physiol 2020;10:1607.

Mousa A, Naderpoor N, Teede H, Scragg R, de Courten B, et al. Vitamin D supplementation for improvement of chronic low-grade inflammation in patients with type 2 diabetes: a systematic review and meta-analysis of randomized controlled trials. Nutr Rev 2018;76: 380-394.

IssueVol 8, No 2, 2023 QRcode
SectionResearch Article(s)
Whey protein Diabetes mellitus Type 2 diabetes Complementary medicine

Rights and permissions
Creative Commons License This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.
How to Cite
Pezeshki B, Pourmontaseri H, Sedigh Rahimabadi M, Haghjoo E, Ostovar M, Dehghan A, Zarenezhad E, Rostami Chijan M. A Complementary Therapy with Whey Protein in Diabetes: A Double-Blind Randomized Controlled Clinical Trial. Trad Integr Med. 2023;8(2):149-155.