Short-Term Dietary Exposures and Thrombin Generation in Tanzanian Men: Exploratory Coagulation-Focused Analysis of a Randomized Dietary-Switch Trial.

Abstract

Background: Rapid dietary transitions in sub-Saharan Africa may alter coagulation profiles; however, this remains poorly characterized.

Methods: An open-label dietary-intervention trial in Tanzania enrolled 77 healthy men aged 20 to 40 years. They underwent 1 of 3 interventions (n=22 per arm): heritage-to-Western-style diet switch (2 weeks), Western-to-heritage diet switch (2 weeks), or continued their habitual Western-style diet with daily consumption of 1 L of a traditional fermented banana-millet beverage (Mbege) for 1 week. The 2 diet-switch arms had 5 habitual-diet controls each, while the Mbege arm had no parallel control group. Plasma was collected at baseline, postintervention, and 4-week follow-up. We quantified plasma coagulation proteins and assessed thrombin and plasmin generation. Coagulation analyses were prespecified secondary end points but are interpreted as exploratory because no formal coagulation outcome hierarchy was prespecified.

Results: In control-adjusted analyses, the heritage-to-Western-style diet switch was associated with higher endogenous thrombin potential at 5 pM recombinant tissue factor postintervention compared with baseline (fold-change ratio, 1.19 [95% CI, 1.01-1.41]; nominal P=0.037). Prothrombin increased within the heritage-to-Western intervention arm (98.0%-104.5%; P_FDR=0.027), but not relative to habitual-diet controls (fold-change ratio, 1.05 [95% CI, 0.93-1.18]; P=0.443). In the uncontrolled Mbege arm, fibrinogen, prothrombin, FVIII (factor VIII), and antithrombin decreased, while endogenous thrombin potential at 1 pM recombinant tissue factor increased. The Western-style-to-heritage diet switch showed limited consistent changes in coagulation readouts.

Conclusions: Short-term dietary westernization was associated with higher control-adjusted endogenous thrombin potential at 5 pM recombinant tissue factor, while the within-arm increase in prothrombin did not remain significant relative to controls. The uncontrolled Mbege arm showed a distinct pattern, with lower plasma concentrations of several coagulation proteins but higher endogenous thrombin potential at 1 pM recombinant tissue factor. These findings suggest that short-term dietary exposures may influence thrombin generation. However, given the small control groups, uncontrolled Mbege arm, and nonisocaloric design, these results are exploratory and require confirmation in larger controlled studies.

Registration: URL: https://www.isrctn.com/ISRCTN15619939?; Unique identifier: ISRCTN15619939.