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US-12622446-B2 - Fiber mix formulations and uses thereof

US12622446B2US 12622446 B2US12622446 B2US 12622446B2US-12622446-B2

Abstract

The present disclosure relates to a fiber mix formulation comprising a mixture of bran, inulin, and digestion resistant maltodextrin useful to restore a healthier gut microbiota and alleviate symptoms in subjects with imbalance of gut microbiota. The mixture of soluble dietary fiber (SDF) and insoluble dietary fiber (ISDF) with a ratio of ISDF:SDF (0.5:1 to 1:0.5), has synergistic effect on gut microbiota composition, promoting the growth of the acetate- and butyrate-producing bacteria and inhibiting the growth of pathogens and detrimental bacteria.

Inventors

  • Liping Zhao
  • Yan Yan LAM
  • Yongjia GONG
  • Guojun Wu
  • Cuiping ZHAO

Assignees

  • RUTGERS, THE STATE UNIVERSITY OF NEW JERSEY

Dates

Publication Date
20260512
Application Date
20210407

Claims (20)

  1. 1 . A formulation comprising: a mixture of bran, inulin, and digestion resistant maltodextrin; wherein the bran consists essentially of corn bran, wheat bran, sorghum bran, and oat bran; wherein the inulin is in a range of 5-8% of total weight of the mixture; wherein the digestion resistant maltodextrin is in a range of 5-8% of total weight of the mixture; wherein the mixture comprises a total dietary fiber content in a range of from about 36% to about 47% (w/w); wherein the mixture has a ratio of dietary fibers from bran:dietary fibers from inulin:dietary fibers from digestion resistant maltodextrin ranging from about 1:1:1 to about 4:1:1; and wherein the mixture has a uniform particle size between 150 μm and 300 μm.
  2. 2 . The formulation of claim 1 , wherein a ratio of fiber contributed by each of the corn bran, wheat bran, sorghum bran, and oat bran is about 1:1:1:1 by weight.
  3. 3 . The formulation of claim 1 , wherein the formulation comprises about 7-8% inulin by weight.
  4. 4 . The formulation of claim 1 , wherein the formulation comprises about 7.8% inulin by weight.
  5. 5 . The formulation of claim 1 , wherein the digestion resistant maltodextrin is a soluble corn fiber.
  6. 6 . The formulation of claim 5 , wherein the digestion resistant maltodextrin is present at a final percentage of about 7.5% (w/w).
  7. 7 . The formulation of claim 1 , further comprising xanthan gum.
  8. 8 . The formulation of claim 7 , wherein the xanthan gum is present at a final percentage of about 4% (w/w).
  9. 9 . A method for promoting a healthy gut microbiome in a subject in need thereof, the method comprising: enterally administering to the subject an effective amount of the formulation of claim 1 , wherein the effective amount is sufficient to increase proliferation of acetate-producing and butyrate-producing gut bacteria species in the subject's gut, thereby promoting the healthy gut microbiome in the subject.
  10. 10 . The method of claim 9 , wherein the effective amount of the formulation comprises 30-90 grams of fiber per day.
  11. 11 . The method of claim 9 , wherein the effective amount of the formulation comprises 30-60 grams of fiber per day.
  12. 12 . The method of claim 9 , wherein the acetate-producing and butyrate-producing gut bacteria species are classified in a bacterial genus comprising at least one of genus of Bifidobacterium, Ruminococcus, Eubacterium, Clostridium, Alistipes, Bacteroides, Blautia, Butyricicoccus, Butyricimonas, Collinsella, Coprococcus, Dorea, Eggerthella, Faecalibacterium, Fusicatenibacter, Intestinimonas, Lachnoclostridium, Lachnospiraceae, Megasphaera, Parabacteroides, Paraprevotella, Phascolarctobacterium, Roseburia, Ruminiclostridium , or Subdoligranulum , wherein the acetate-producing and butyrate-producing gut bacteria species are classified in a bacterial family comprising at least one of Acidaminococcaceae, Bacteroidaceae, Bifidobacteriaceae, Clostridiaceae, Clostridiales, Coriobacteriaceae, Eggerthellaceae, Enterobacteriaceae, Erysipelotrichaceae, Lachnospiraceae, Marinifilaceae, Prevotellaceae, Rikenellaceae, Ruminococcaceae, Tannerellaceae, or Veillonellaceae.
  13. 13 . The method of claim 9 , wherein the acetate-producing and butyrate-producing gut bacteria species are detected by 16S rRNA amplicon sequencing targeting one or more of the variable regions V4, V3-V4 or the full-length gene.
  14. 14 . The method of claim 13 , wherein the 16S rRNA V4 amplicon sequencing identifies one or more amplicon sequence variant (ASV) characteristic of the acetate-producing and butyrate-producing gut bacteria.
  15. 15 . The method of claim 14 , wherein each of the one or more ASVs represents a unique bacterial strain or a group of highly similar strains of the acetate-producing and butyrate-producing gut bacteria.
  16. 16 . The method of claim 9 , wherein the subject in need thereof has an imbalance of gut microbiota.
  17. 17 . The method of claim 16 , wherein the imbalance of gut microbiota is characterized by low levels of acetate-producing and butyrate-producing gut bacteria.
  18. 18 . The method of claim 17 , wherein the low levels of acetate-producing and butyrate-producing gut bacteria are less than 5% of total gut microbiota in the subject in need thereof.
  19. 19 . The method of claim 17 , wherein the acetate-producing and butyrate-producing gut bacteria species are classified in a bacterial genus comprising at least one of Bifidobacterium, Ruminococcus, Eubacterium, Clostridium, Alistipes, Bacteroides, Blautia, Butyricicoccus, Butyricimonas, Collinsella, Coprococcus, Dorea, Eggerthella, Faecalibacterium, Fusicatenibacter, Intestinimonas, Lachnoclostridium, Lachnospiraceae, Megasphaera, Parabacteroides, Paraprevotella, Phascolarctobacterium, Roseburia, Ruminiclostridium , or Subdoligranulum.
  20. 20 . The method of claim 17 , wherein the acetate-producing and butyrate-producing gut bacteria species are detected by 16S rRNA V4 amplicon sequencing.

Description

RELATED APPLICATIONS This patent application is a national phase filing under 35 U.S.C. 371 of International Application No. PCT/US2021/026258, filed on Apr. 7, 2021, which claims the benefit of and the priority to U.S. Provisional Patent Application Ser. No. 63/006,896, filed Apr. 8, 2020, the entirety of each of which is incorporated by reference in its entirety. SEQUENCE LISTING The instant application contains a Sequence Listing which has been submitted electronically in ASCII format and is hereby incorporated by reference in its entirety. Said ASCII copy, created on Apr. 7, 2021, is named 117465-016701PCT_SL.txt and is 49,521 bytes in size. FIELD The present disclosure relates to a fiber mix formulation useful for in vitro and in vivo indications. BACKGROUND The gut ecosystem is regarded as foundational for human health. Developing strategies to promote and maintain a healthy gut microbiota is one of the key priorities in recent medical research. Dysbiosis (an imbalance of beneficial and detrimental intestinal microbes) is associated with metabolic diseases, including obesity and type 2 diabetes. SUMMARY Covered embodiments are defined by the claims, not this summary. This summary is a high-level overview of various aspects and introduces some of the concepts that are further described in the Detailed Description section below. This summary is not intended to identify key or essential features of the claimed subject matter, nor is it intended to be used in isolation to determine the scope of the claimed subject matter. The subject matter should be understood by reference to appropriate portions of the entire specification, any or all drawings, and each claim. Aspects of the present disclosure relate to a formulation comprising a mixture of bran, inulin, and digestion resistant maltodextrin, wherein the bran consists essentially of corn bran, wheat bran, sorghum bran, and oat bran, wherein the mixture has a ratio of dietary fibers from bran:dietary fibers from inulin:dietary fibers from digestion resistant maltodextrin ranging from about 1:1:1 to about 4:1:1, wherein the inulin is present in a range of 5-10% of total weight of the mixture, and wherein the mixture has a uniform particle size between 150 μm and 300 μm. In some embodiments, the ratio of fiber contributed by each of the corn bran, wheat bran, sorghum bran, and oat bran is about 1:1:1:1 by weight. In some embodiments, the formulation comprises about 7-8% inulin by weight. In some embodiments, the formulation comprises about 7.8% inulin by weight. In some embodiments, the total fiber content is about 47% (w/w). In some embodiments, the digestion resistant maltodextrin is Fibersol-2®, a soluble corn fiber. In some embodiments, the Fibersol-2® is present at a final percentage of about 7.8% (w/w). In some embodiments, the formulation further comprises xanthan gum. In some embodiments, the xanthan gum is present at a final percentage of about 4% (w/w). Other aspects of the present disclosure relate to methods for promoting a healthy gut microbiome in a subject in need thereof, the method comprising enterally administering to the subject an effective amount of the formulation comprising a mixture of bran, inulin, and digestion resistant maltodextrin, wherein the bran consists essentially of corn bran, wheat bran, sorghum bran, and oat bran, wherein the mixture has a ratio of dietary fibers from bran:dietary fibers from inulin:dietary fibers from digestion resistant maltodextrin ranging from about 1:1:1 to about 4:1:1, wherein the inulin is present in a range of 5-10% of total weight of the mixture, and wherein the mixture has a uniform particle size between 150 μm and 300 μm, wherein the effective amount is sufficient to increase proliferation of acetate-producing and butyrate-producing gut bacteria in the subject's gut, thereby promoting the healthy gut microbiome in the subject. In some embodiments, the effective amount of the formulation comprises 30-90 grams of fiber per day. In some embodiments, the effective amount of the formulation comprises 30-60 grams of fiber per day. In some embodiments, the effective amount of the formulation comprises 30-120 grams of fiber per day. In some embodiments, the acetate-producing and butyrate-producing gut bacteria species are classified in a bacterial genus comprising at least one of Bifidobacterium, Ruminococcus, Eubacterium, Clostridium, Alistipes, Bacteroides, Blautia, Butyricicoccus, Butyricimonas, Collinsella, Coprococcus, Dorea, Eggerthella, Faecalibacterium, Fusicatenibacter, Intestinimonas, Lachnoclostridium, Lachnospiraceae, Megasphaera, Parabacteroides, Paraprevotella, Phascolarctobacterium, Roseburia, Ruminiclostridium, or Subdoligranulum, wherein the acetate-producing and butyrate-producing gut bacteria species are classified in a bacterial family comprising at least one of Acidaminococcaceae, Bacteroidaceae, Bifidobacteriaceae, Clostridiaceae, Clostridiales, Coriobacteriaceae, Eggerthellaceae