Evidence map›Paper›PMID 39835082›Full record

ArticleCureus2024

Efficacy and Safety of F-Biotic™ in Combination With Metformin for Type 2 Diabetes Mellitus: Results From a Randomized, Double-Blind Clinical Trial.

Smiju Devassy, Sheejamol S, Santhosh Kumar A K, Balprakash Nair

Abstract read
In one paragraph

Article in Cureus, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Review
  2. Probiotics,Metabolism open · 2025
    Article
  3. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

4 authors.

Smiju DevassyDiabetes and Endocrinology, Arishina Life Sciences, Karnataka, IND.
Sheejamol SClinical Studies, Arishina Life Sciences, Karnataka, IND.
Santhosh Kumar A KDiabetes and Endocrinology, Arishina Life Sciences, Karnataka, IND.
Balprakash NairDiabetes and Endocrinology, Arishina Life Sciences, Karnataka, IND.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionThis study evaluated the effectiveness, safety, and tolerability of F-Biotic™ (Arishina Life Sciences, Karnataka, IND), a prebiotic containing 60% resistant starch derived from natural sources, in patients with Type 2 diabetes mellitus (T2DM) on stable metformin therapy.

methodsSeventy participants with T2DM, aged 25-70 years, were randomized into two groups: one receiving F-Biotic™ and the other a placebo, both administered daily for 12 weeks. Key outcomes included fasting blood sugar (FBS), postprandial blood sugar (PPBS), glycated hemoglobin (HbA1c), fasting insulin, insulin resistance (HOMA-IR), GLP-1 levels, lipid profile, and quality of life.

resultsThe F-Biotic™ group exhibited significant reductions in FBS from 150.18 ± 34.78 mg/dL at baseline to 134.24 ± 39.91 mg/dL by the end of the study, compared to an increase in the placebo group from 148.61 ± 42.13 mg/dL to 157.71 ± 47.84 mg/dL. PPBS decreased by -32.97 ± 67.18 mg/dL in the F-Biotic™ group versus an increase of 21.00 ± 36.59 mg/dL in the placebo group. GLP-1 levels increased significantly in the F-Biotic™ group, while they decreased in the placebo group. No significant changes were observed in HbA1c, fasting insulin, or HOMA-IR, and no adverse events related to the investigational product were reported.

conclusionF-Biotic™ appears to be a promising adjunctive therapy for T2DM, demonstrating significant improvements in glycemic control and quality of life without adverse events related to the investigational product. Further research with longer follow-ups and larger samples is needed to confirm these findings and evaluate long-term efficacy and safety.

Indexed as

diabetes mellitusglucagon-like peptide 1glycemic controlprebioticsquality of life

Identifiers

PMID39835082
PMCPMC11743766

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.