A Novel Multiphase Modified Ketogenic Diet: An Effective and Safe Tool for Weight Loss in Chinese Obese Patients

Abstract

Purpose

The aim of the present study was to investigate the effect and safety of a multiphase modified ketogenic diet (MMKD) compared to beinaglutide treatment or lifestyle modification (LM) alone on weight loss in obese patients in China.

Patients and Methods

The present study was conducted in adults with obesity who did not have diabetes with two phases as follows: a 4-week run-in phase to guide diet and exercise, followed by a 12-week intervention phase aiming to lose weight. All participants performed aerobic and resistance exercise, and they were free to select any one of three weight-loss strategies as follows: LM group, 12 weeks of hypocaloric balanced diet (HBD); MMKD group, two cycles of a multiphase diet with each cycle comprised of 2 weeks of ketogenic diet (KD), 2 weeks of transition diet and 2 weeks of HBD; and beinaglutide group, 12 weeks of HBD plus daily injection of beinaglutide (0.4 mg per day). Body weight, body composition and metabolic variables were measured before and after the 12 weeks of treatment.

Results

All intervention strategies had significant weight loss, and the MMKD led to greater weight loss than LM (difference, −3.7 kg; 95% confidence interval [CI], −6.1 to −1.4; P = 0.001) but not beinaglutide (difference, −1.5 kg; 95% CI, −4.3 to 1.3; P = 0.587). Waist circumference (WC), fat mass, body fat percentage (BFP) and visceral fat area (VFA) were also significantly decreased, and the MMKD had a greater effect on these parameters than LM or beinaglutide. In addition, significant reductions in blood pressure and homoeostatic model assessment of insulin resistance (HOMA-IR) were observed in all three groups, but the MMKD resulted in the most significant improvement in insulin resistance. Almost no adverse events, except for two cases of dizziness, were observed in the MMKD group, which was significantly fewer events than the other two groups.

Conclusion

These findings demonstrated that the MMKD is an effective and safe treatment for weight loss, thus providing an additional option for obese Chinese patients.

Keywords:

• dietary therapy
• obesity
• beinaglutide
• lifestyle modification

Abbreviations

KD, ketogenic diet; MMKD, multiphase modified ketogenic diet; GLP-1 RAs, glucagon-like peptide 1 receptor agonists; LM, lifestyle modification; T2DM, type 2 diabetes mellitus; HBA1c, glycated hemoglobin 1c; HOMA-IR, homoeostatic model assessment of insulin resistance; BMI, body mass index; HBD, hypocaloric balanced diet; WC, waist circumference; HC, hip circumference; WHR, waist-to-hip ratio; SMM, skeletal muscle mass; BFP, body fat percentage; VFA, visceral fat area; TC, total cholesterol; LDL-C, low-density lipoprotein-cholesterol; HDL-C, high-density lipoprotein-cholesterol; TG, triacylglycerol; FBG, fasting blood glucose; FINS, fasting plasma insulin; P2hBG, 2h postprandial glucose; P2hINS, 2h postprandial insulin; ITT, intention to treat analysis; PP, per-protocol analysis; CI, confidence interval.

Data Sharing Statement

The data presented in this study are available upon request from the corresponding author. The data are not publicly available due to privacy reasons.

Ethics Approval and Informed Consent

The present study was conducted according to the guidelines of the Declaration of Helsinki and approved by the Ethics Committee of the Affiliated Wuxi People’s Hospital of Nanjing Medical University (KYLLKS 201806, 26 April 2018). This trial was registered in the Chinese Clinical Trial Registry (ChiCTR 1800015923). Informed consent was obtained from all subjects involved in the study.

Consent for Publication

All authors gave final approval of the version to be published and agreed to be listed as authors.

Acknowledgments

We thank all the participants in this study. We thank Shanghai Benemae Pharmaceutical Corporation for providing beinaglutide and injector pens. We also thank the expert support from Dalong Zhu and Yan Bi.

Disclosure

The authors declare no conflict of interest in this work.

Additional information

Funding

This work was supported by the Project of Jiangsu Health Commission (LGY2019018), the Top Talent Support Program for young and middle-aged people of Wuxi Health Committee (BJ2020005) and the Wuxi Science and Technology Development Fund (Y20212024).