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The effects of whey protein on anthropometric parameters, resting energy expenditure, oxidative stress, and appetite in overweight/obese women with type 2 diabetes mellitus: A randomized placebo controlled clinical trial

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Abstract

Background

Insufficient data are available on the effects of long-term whey protein (WP) consumption on patients with type 2 diabetes mellitus (T2DM). So, in this study, we aimed to examine the effects of WP combined with individualized diet on anthropometric parameters, resting energy expenditure (REE), oxidative stress markers, and appetite among overweight/obese women with T2DM.

Methods

In this 3-month double-blind placebo-controlled randomized clinical trial, 48 women with T2DM were randomly allocated into either WP group (one bread fortified by 20 g whey protein concentrates (WPC)) or placebo group (one unfortified bread) along with their individualized diets. At both pre- and post-intervention phases, physical activity, anthropometric parameters, REE, appetite, and serum levels of total antioxidant capacity (TAC) and malondialdehyde (MDA) as well as diet were assessed.

Results

Thirty-five patients completed the trial. At the endpoint, there were no significant between-group differences for anthropometric parameters (p > 0.05), except for waist circumference (WC), which was lower in the WP group after adjusting for the confounders (p = 0.040). Serum level of MDA was significantly decreased in the WP group (p = 0.022). There were no significant within- or between-group changes for serum levels of TAC, REE, and appetite sensations (p > 0.05), except for the “hunger”, which was lower in the WP group after adjusting for the confounders (p = 0.045).

Conclusion

Regarding significant reduction in WC, serum levels of MDA, and feeling of hunger, consumption of the WPC fortified bread could be beneficial in women with T2DM.

Registration Number: IRCT20110123005670N26; Registration date: 2019/01/07.

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Data Availability

All data of present study are with the corresponding author.

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Acknowledgments

We sincerely thank the patients who participated in the present clinical trial. Present paper is based on the data obtained from a Ph. D. dissertation submitted to Tabriz University of Medical Sciences (Maryam Nouri; Grant number: 60927).

Funding

This work was supported by the [Research Vice-Chancellor of Tabriz University of Medical Sciences] under Grant [number: 60927]; and [Iran National science Foundation (INSF)] under Grant [number: 97014692].

Author information

Authors and Affiliations

  1. Student Research Committee, Student Research Center, Tabriz University of Medical Sciences, Tabriz, Islamic Republic of Iran

    Maryam Nouri

  2. Department of Nutrition Sciences, Varastegan Institute for Medical Sciences, Mashhad, Iran

    Maryam Nouri

  3. Nutrition Research Center, Faculty of Nutrition and Food Sciences, Tabriz University of Medical Sciences, Attar Nishabouri St., Tabriz, Islamic Republic of Iran

    Bahram Pourghassem Gargari & Ali Tarighat-Esfanjani

  4. Department of Food Sciences and Technology, Faculty of Nutrition and Food Sciences, Tabriz University of Medical Sciences, Tabriz, East Azarbaijan, Islamic Republic of Iran

    Zahra Ghasempour

  5. Endocrine Research Center, Tabriz University of Medical Sciences, Tabriz, IR, Iran

    Vahideh Sadra

  6. Cabrini Research, Cabrini Health, 154 Wattletree Rd, Melbourne, VIC, 3144, Australia

    Mohammad Asghari Jafarabadi

  7. Department of Statistics and Epidemiology, School of Medicine, Zanjan University of Medical Sciences, Zanjan, Iran

    Mohammad Asghari Jafarabadi

  8. Road Traffic Injury Research Center, Tabriz University of Medical Sciences, Tabriz, Iran

    Mohammad Asghari Jafarabadi

  9. Student Research Committee, Varastegan Institute for Medical Sciences, Mashhad, Iran

    Arvin Babaei & Pedram Tajfar

Authors
  1. Maryam Nouri
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  2. Bahram Pourghassem Gargari
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  8. Ali Tarighat-Esfanjani
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Contributions

All authors contributed to the study conception and design. Material preparation and data collection were performed by Maryam Nouri. Data analysis was performed by Maryam Nouri and Mohammad Asghari Jafarabadi. The first draft of the manuscript was written by Maryam Nouri and all authors commented on previous versions of the manuscript. All authors read and approved the final manuscript.

Corresponding author

Correspondence to Ali Tarighat-Esfanjani.

Ethics declarations

Ethics approval

The Ethics Committee of Tabriz University of Medical Sciences, Tabriz, Iran (ethics code; IR.TBZMED.REC.1397.687) approved this study. This research was conducted according to the Declaration of Helsinki. The present trial was registered in the Iranian Registry of Clinical Trials (http://www.irct.ir, Registration Number: IRCT20110123005670N26).

Research involving human participants

All procedures followed were in accordance with the ethical standards of the responsible committee on human experimentation (The Ethics Committee of Tabriz University of Medical Sciences, Tabriz, Iran (date of approval: 11.19.2019) (ethics code; IR.TBZMED.REC.1397.687)) and with the Helsinki Declaration of 1964 and later versions.

Consent to participate

Informed consent or substitute for it was obtained from all patients for being included in the study.

Conflict of interest

Authors declare no conflict of interest.

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Nouri, M., Gargari, B.P., Ghasempour, Z. et al. The effects of whey protein on anthropometric parameters, resting energy expenditure, oxidative stress, and appetite in overweight/obese women with type 2 diabetes mellitus: A randomized placebo controlled clinical trial. Int J Diabetes Dev Ctries 44, 155–166 (2024). https://doi.org/10.1007/s13410-023-01186-4

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