JOURNAL OF INTEGRATIVE NUTRITION
INTERVENTION DESIGN PROPOSAL
Paleo Nutritional Intervention for Type 2 Diabetes Mellitus: A Systematic Reevaluation and Consensus Report; Definition and Macronutrient Proposal for Trials
Hollywood JB, Whitfield M, Kaufman P, Davis K
FIRST PUBLISHED
February 1, 2025
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ABSTRACT
Background: Dietary interventions, including the Paleo diet (PD) play a crucial role in the treatment of patients with type 2 diabetes mellitus (T2DM). However, the clinical significance of them remains ambiguous due to limited conclusive studies.
Objective: We conducted a systematic review to reevaluate existing research on the PD in individuals with T2DM, specifically focusing on whether this diet demonstrates a discernible improvement in metabolic biomarkers, further aiming to assess variables of interest (clinical definition, macronutrient ranges, and glycemic index of a PD) across trials.
Methods: Online databases were searched for clinical trials and systematic reviews that included the PD as an intervention on patients with T2DM, from which 32 publications were selected. A random effects model was utilized to assess the difference in reported metabolic biomarkers from baseline to end-of-intervention time point. Variables of interest were analyzed across trials.
Results: Four articles met inclusion criteria. The overall effect for the PD intervention across pooled studies was only significant for DBP (P<.001). Significant heterogeneity was found among pooled studies for the PD (FBG [P=.03; I²=67%], glucose AUC₀₋₁₂₀ [P=.002; I²=84%], SBP [P<.001; I²=93%], TC [P=.007; I²=80%], LDL [P<.001; I²=99%], and TG [P=0.04; I²=69%]) and the control diets (wt [P<.001; I²=99%], wc [P<.001; I²=99%], sodium:potassium ratio [P<.001; I² = 96%], and HDL [P<.001; I²=87%]). A PD definition, macronutrient ranges, and glycemic index was proposed for conducting future trials.
Conclusion: The inconclusiveness of the PD for T2DM was due to a number of inconsistencies across trials and systematic reviews. As a result, we propose consistency of PD definition (archeological definition and no modern-day interpretations, assumptions, or allowances of excluded foods), standardized macronutrient percentages, disease diagnosis, trial time length, and equal training across groups for all future trials. A standard control diet, such as the ADA diet, should be used as a comparison. The reduction in DBP across pooled results suggests that the PD may have a beneficial impact on metabolic markers related to T2DM.
COI STATEMENT
The author declares that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.
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CITE ARTICLE
Hollywood JB, Whitfield M, Kaufman P, & Davis K. Paleo Nutritional Intervention for Type 2 Diabetes Mellitus: A Systematic Reevaluation and Consensus Report; Definition and Macronutrient Proposal for Trials. J Int Nutr. 2025;1(1):105-123. doi: 10.64437/jin0124013.