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Randomized Controlled Trial
. 2024 Jun 26:12:e17583.
doi: 10.7717/peerj.17583. eCollection 2024.

Microbiota based personalized nutrition improves hyperglycaemia and hypertension parameters and reduces inflammation: a prospective, open label, controlled, randomized, comparative, proof of concept study

Gopalakrishna Kallapura #  1 , Anthony Surya Prakash  1 , Kumar Sankaran  1 , Prabhath Manjappa  1 , Prayagraj Chaudhary  2 , Sanjay Ambhore  3 , Debojyoti Dhar #  1
Affiliations
Randomized Controlled Trial

Microbiota based personalized nutrition improves hyperglycaemia and hypertension parameters and reduces inflammation: a prospective, open label, controlled, randomized, comparative, proof of concept study

Gopalakrishna Kallapura et al. PeerJ. .

Abstract

Background: Recent studies suggest that gut microbiota composition, abundance and diversity can influence many chronic diseases such as type 2 diabetes. Modulating gut microbiota through targeted nutrition can provide beneficial effects leading to the concept of personalized nutrition for health improvement. In this prospective clinical trial, we evaluated the impact of a microbiome-based targeted personalized diet on hyperglycaemic and hyperlipidaemic individuals. Specifically, BugSpeaks®-a microbiome profile test that profiles microbiota using next generation sequencing and provides personalized nutritional recommendation based on the individual microbiota profile was evaluated.

Methods: A total of 30 participants with type 2 diabetes and hyperlipidaemia were recruited for this study. The microbiome profile of the 15 participants (test arm) was evaluated using whole genome shotgun metagenomics and personalized nutritional recommendations based on their microbiota profile were provided. The remaining 15 participants (control arm) were provided with diabetic nutritional guidance for 3 months. Clinical and anthropometric parameters such as HbA1c, systolic/diastolic pressure, c-reactive protein levels and microbiota composition were measured and compared during the study.

Results: The test arm (microbiome-based nutrition) showed a statistically significant decrease in HbA1c level from 8.30 (95% confidence interval (CI), [7.74-8.85]) to 6.67 (95% CI [6.2-7.05]), p < 0.001 after 90 days. The test arm also showed a 5% decline in the systolic pressure whereas the control arm showed a 7% increase. Incidentally, a sub-cohort of the test arm of patients with >130 mm Hg systolic pressure showed a statistically significant decrease of systolic pressure by 14%. Interestingly, CRP level was also found to drop by 19.5%. Alpha diversity measures showed a significant increase in Shannon diversity measure (p < 0.05), after the microbiome-based personalized dietary intervention. The intervention led to a minimum two-fold (Log2 fold change increase in species like Phascolarctobacterium succinatutens, Bifidobacterium angulatum, and Levilactobacillus brevis which might have a beneficial role in the current context and a similar decrease in species like Alistipes finegoldii, and Sutterella faecalis which have been earlier shown to have some negative effects in the host. Overall, the study indicated a net positive impact of the microbiota based personalized dietary regime on the gut microbiome and correlated clinical parameters.

Keywords: Gut microbiome; HbA1c; Hyperglycemia; Personalized nutrition; Type 2 diabetes.

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Conflict of interest statement

Gopalakrishna Kallapura, Anthony Surya Prakash, Kumar Sankaran, Prabhath Manjappa and Debojyoti Dhar are employed by Leucine Rich Bio Pvt Ltd and Sanjay Ambhore by Shreya Clinic.

Figures

Figure 1
Figure 1. Study design.
A flow chart depicting the study design, with two arms of the study, list of clinical parameters evaluated as primary end points and the microbiome profiling for the intervention arm (left).
Figure 2
Figure 2. Change in HbA1c levels.
(A) Overall change in HbA1c levels across the arms, where ***p < 0.001. (B and C) Change in HbA1c levels in each individual, within the BugSpeaks personalized nutrition arm and the regular nutrition arm, respectively. (D) Overall % drop between the two arms.
Figure 3
Figure 3. Change in blood pressure parameters.
(A) Overall change in systolic and diastolic pressures across the comparing arms of regular nutrition and BugSpeaks nutrition. (B) Change in systolic and diastolic pressures within a sub-cohort of patients in BugSpeaks nutrition showing a significant reduction in systole within the arm, with **p < 0.01.
Figure 4
Figure 4. Differential abundance across phylum (A) and genus (B) levels.
Figure 5
Figure 5. Change in serum CRP levels.
CRP levels were found to be decreased by 20% post intervention by BugSpeaks® personalized nutrition.
Figure 6
Figure 6. Changes in diversity of gut microbiome, within the BugSpeaks nutrition arm.
Changes in Shannon alpha diversity measure across kingdoms
Figure 7
Figure 7. Changes in Shannon and Chao1 diversity of gut microbiome.
(A) Significant change in Shannon alpha diversity measure post intervention with BugSpeaks Nutrition. (B) Changes in Chao1 diversity measure between pre and post BugSpeaks nutritional intervention. (C) Beta diversity measure by Bray-Curtis distance between pre and post BugSpeaks nutritional intervention.
Figure 8
Figure 8. Significantly differentially abundance species.
(A) Log2 Fold Change, of some of the most differentially abundant species; (A–H) Differential abundance of species that were differentially abundant (*p-value < 0.05).
Figure 9
Figure 9. Network analysis.
(A) Network of associations pre-intervention, along with (B) network of associations post-intervention with BugSpeaks personalized nutrition. The features of the network include: edge thickness is proportional to the Spearman correlation between species, edges are deleted if Spearman is below the thresholds highlighted above, blue-coloured edge represents a negative correlation, while a pink-coloured edge represents positive correlation; finally different node colours were used for different kingdoms.
Figure 10
Figure 10. (A–C) Correlation analysis.
(A and B) Specifically showing positive (high Spearman correlation coefficient) and negative (low Spearman correlation coefficient) correlations between two species.
Figure 11
Figure 11. Hierarchical clustering pre and post intervention.
Heat maps representing the clustering of species based on Spearman correlation. (A) Pre-intervention and (B) post-intervention. Higher number of positive correlations were observed post intervention with BugSpeaks® personalized nutrition.
Figure 12
Figure 12. Trial summary.
The trial showed that BugSpeaks®personalized nutrition led to improvement in HbA1c, CRP and blood pressure parameters in Type 2 diabetic patients. This improvement may be attributed to an increase in beneficial microbes such as Bifidobacterim angulatum and Levilactobacillus brevis. Possible mechanism may also include better balance between succinate producers and consumers in the host leading to appropriate concentration of succinate in the system. All icons, graphics are used by utilizing Canva pro account (www.canva.com).
See this image and copyright information in PMC

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Grants and funding

This work was funded by Leucine Rich Bio Pvt Ltd. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.
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