Background: Large variability exists in people’s responses to foods. However, the efficacy of personalised dietary advice for health remains understudied [1,2]. The ZOE METHOD trial (NCT05273268) compared the effects of following a personalised dietary program (PDP) versus the USDA recommended diet (control) on cardiometabolic health. Methods: A randomised clinical trial was conducted in 347 US-based participants aged 41–70 years, representative of the average US population. The PDP provided dietary advice that incorporated food characteristics, glucose and triglyceride (TG) responses to foods (1), individuals’ microbiomes (2), and health history, to produce personalised food scores delivered as an 18-week program via the ZOE app. Primary outcomes were plasma low-density lipoprotein cholesterol (LDL-C) and TG concentrations measured at baseline and 18 weeks after random assignment to treatment. Secondary outcomes included weight, waist circumference, HbA1c, and microbiome composition. Results: In total, 86% of the participants were female, with a mean (±SD) age of 52 ± 7.5 y, BMI of 34 ± 5.8kg/m2, LDL-C of 3.7 mmol/L (95% CI: 3.3, 3.4), and TG of 1.4 mmol/L (95% CI: 1.3, 1.4). Intention to treat analysis (n = 347) showed a significant reduction in TG concentrations following PDP versus control; mean difference in changes were −0.13mmol/L (log-transformed 95% CI: −0.07, −0.01, p-value = 0.016); mean within group changes were −0.21 mmol/L (95% CI: −0.3, −0.1) and −0.07 mmol/L (95% CI: −0.2, −0.02) in PDP and control, respectively. LDL-C did not differ between groups. There were reductions in body weight (−2.5 kg, −3.7, −1.3) and waist circumference (−2.4 cm, −4.1, −0.6), and increases in gut microbiome diversity (Bray–Curtis dissimilarity) following PDP against the control. Within the PDP treatment, highly adherent participants showed improvements (baseline versus 18-week) in LDL-C (by −0.2 ± 0.5 mmol/L), waist circumference (by −6.3 ± 5.4 cm), diastolic blood pressure (by −4.1 ± 8.6 mmHg), and HbA1c (by −0.06 ± 0.2%), which were greater than low adherent participants (p < 0.05 for all). Discussion: Following the personalised dietary advice versus standard care for 18-week improved the TG, body weight, waist circumference, and gut microbiome composition, with greater improvements in highly adherent participants.
Author Contributions
Conceptualization S.E.B., J.W. and T.D.S.; Formal analysis: K.M.B. and L.P.; Data collection: S.E.B. and I.L.; writing—original draft preparation: K.M.B., S.E.B. and T.D.S.; writing—review and editing K.M.B., S.E.B., J.W., I.L., L.P. and T.D.S.; Funding acquisition: J.W. and T.D.S.; Study coordination: S.E.B., W.J.B., T.D.S. and J.W. All authors have read and agreed to the published version of the manuscript.
Funding
This research was funded by ZOE Ltd.
Institutional Review Board Statement
Ethical approval for the trial was obtained through Advarra Institutional Review Board (IRB no. 00000971).
Informed Consent Statement
Informed consent was obtained from all subjects involved in the study.
Data Availability Statement
Not applicable.
Conflicts of Interest
T.D.S., J.W. and G.H. are co-founders of Zoe Ltd. T.D.S. and S.E.B. are consultants to Zoe Ltd. K.M.B, I.L., L.P., J.W., W.J.B., are employees of Zoe Ltd. I.L., L.P., J.W., W.J.B., T.D.S. and S.E.B. also receive options in ZOE Ltd. Other authors have no conflict of interest to declare.
References
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