Objective Remission of pre-diabetes to normal is an important health concern which has had little success in the past. This study objective was to determine the effect on remission of pre-diabetes with a high protein (HP) versus high carbohydrate (HC) diet and effects on metabolic parameters, lean and fat body mass in prediabetic, obese subjects after 6 months of dietary intervention.
Research design and methods We recruited and randomized 24 pre-diabetes women and men to either a HP (30% protein, 30% fat, 40% carbohydrate; n=12) or HC (15% protein, 30% fat, 55% carbohydrate; n=12) diet feeding study for 6 months in this randomized controlled trial. All meals were provided to subjects for 6 months with daily food menus for HP or HC compliance with weekly food pick-up and weight measurements. At baseline and after 6 months on the respective diets oral glucose tolerance and meal tolerance tests were performed with glucose and insulin measurements and dual energy X-ray absorptiometry scans.
Results After 6 months on the HP diet, 100% of the subjects had remission of their pre-diabetes to normal glucose tolerance, whereas only 33.3% of subjects on the HC diet had remission of their pre-diabetes. The HP diet group exhibited significant improvement in (1) insulin sensitivity (p=0.001), (2) cardiovascular risk factors (p=0.04), (3) inflammatory cytokines (p=0.001), (4) oxidative stress (p=0.001), (5) increased percent lean body mass (p=0.001) compared with the HC diet at 6 months.
Conclusions This is the first dietary intervention feeding study, to the best of our knowledge, to report 100% remission of pre-diabetes with a HP diet and significant improvement in metabolic parameters and anti-inflammatory effects compared with a HC diet at 6 months.
Trial registration number NCT0164284.
- Insulin Sensitivity
- Cardiovascular Risk Factors
- Dietary Intervention
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Contributors FBS wrote the manuscript, researched data and contributed to the conception, design, coordinated recruitment and following subjects on the study. AEK reviewed patient information, data and edited the manuscript. AB provided information on diets and provided daily food and menus to participants, reviewed and edited the manuscript. JW was the biostatistician in charge of statistical analysis and reviewed the manuscript. CS conducted history and physical examinations of subjects. BD and CG reviewed and edited manuscript and organized patient data. FBS and AEK are the guarantors of this work and, as such, had full access to the data in the study and take responsibility for the integrity of the data and accuracy of the data analysis. The manuscript has been read and approved by all the authors. AEK passed away July 18 2016, prior to publication of this paper. His contributions to diabetes research spanned over 40 years and he mentored numerous students. His presence will be greatly missed.
Funding The study was funded by the American Diabetes Association (7-12-CT-41) and the AD Baskin Research Fund (PIs FBS and AEK). Clinical Trials reg. no. NCT0164284, clinicaltrials.gov.
Competing interests None declared.
Patient consent Obtained.
Ethics approval University of Tennessee Health Science Center Institutional Review Board.
Provenance and peer review Not commissioned; externally peer reviewed.
Data sharing statement No additional data are available.
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