Microbiota Composition and Diversity in Weight Loss Population After the Intake of IQP-AE-103 in a Double-Blind, Randomized, Placebo-Controlled Study

Abstract

The effect of the novel IQP-AE-103 (proprietary combination of dehydrated okra powder and inulin) on body weight reduction and the association with changes in microbiota composition were investigated in a double-blind, randomized, placebo-controlled trial. A total of seventy-two overweight or moderately obese subjects with a body mass index of ≥25 and <35 kg/m2 were randomly allocated to receive IQP-AE-103 or placebo; each group received two IQP-AE-103 or placebo capsules three times daily, respectively. Body weight, body fat, waist circumference, and hip circumference were measured, and fecal samples were collected at baseline and after 12 weeks of intervention. Using 16S rRNA gene sequencing on the fecal samples, the microbiota dissimilarity, diversity, and differences in relative abundance between or within groups were analyzed. At the end of the study, body weight was significantly reduced in the IQP-AE-103 group compared with the placebo group, 5.16 ± 2.39 kg vs. 0.97 ± 2.09 kg (p < 0.001). Subjects from the IQP-AE-103 group who achieved a reduction of ≥5% of total body weight from baseline (hereafter referred to as 5% responders or IQP5) had a mean body weight reduction of 6.74 ± 1.94 kg, significantly greater than the placebo group (p < 0.001). Using Lefse and statistical analysis, subjects in the IQP-AE-103 group had a significantly lower relative abundance of Firmicutes than the placebo group (p < 0.05) after 12 weeks of intervention. The 5% responders from the IQP-AE-103 group had a remarkable 4.6-fold higher relative abundance of Akkermansia muciniphila than the placebo group (p < 0.05). As the significant differences between groups were only observed post-intervention, the overall differences in microbiota profile suggest that the weight loss in overweight and moderately obese subjects who consumed IQP-AE-103 for 12 weeks is accompanied by a positive change in microbiota composition. These changes might be linked to the beneficial effects of microbiome modulations in alleviating obesity and metabolic syndrome. To the best of our knowledge, we are the first to report over-the-counter (OTC) supplementation that results in both significant changes in weight and favorable shifts on the subject microbiota profile. The trial is registered under ClinicalTrials.gov Identifier no. NCT03058367.

Keywords: Akkermansia muciniphila; inulin; metabolic syndrome; microbiota; obesity; okra.

Conflict of interest statement

LP, PD, and PC are the employees of InQpharm Group that funded the study. InQpharm Group was not involved in the conduct of the trial or the collection of data. JC received consultation fees for the independent review of the data and contributed to the manuscript writing.

Copyright © 2022 Peng, Cooper, De Costa and Chong.

Figures

FIGURE 1

Flowchart of the study population from the start until the end of the study.

FIGURE 2

Relative abundance of each phylum at baseline and after 12 weeks is shown as a percentage (%). Pattern-filled columns of the bar chart represent the relative distribution of the five main phyla. Euryarchaeota, Cyanobacteria, Elusimicrobia, Fusobacteria, Lentisphaerae, Spirochaetes, Synergistetes, and Tenericutes are classified as “Other” due to a low abundance level of p < 0.05 compared with placebo; #p < 0.05 compared with baseline within the same groups.

FIGURE 3

Histogram of linear discriminant analysis (LDA) scores showing the taxa abundance distribution of each microbiota classification with a statistical difference after 12 weeks. Bars in red indicate higher abundance in the IQP and IQP5 groups, while purple bars indicate higher abundance in the placebo group. (A) IQP group vs. placebo group; (B) IQP5 group vs. placebo group. Only taxa with LDA effect size > 2 are shown. f_: family; g_: genus, s_: species.

FIGURE 4

Relative abundance presented in percentage (%) of Akkermansia muciniphila in the IQP, IQP5, and placebo groups at baseline and after 12 weeks; *p < 0.05 compared with placebo after 12 weeks. #p < 0.05 compared with baseline within the same groups.