PROFAST: A Randomized Trial Assessing the Effects of Intermittent Fasting and Lacticaseibacillus rhamnosus Probiotic among People with Prediabetes

Abstract

Both intermittent fasting and specific probiotics have shown promise in improving glucose tolerance with a potential for synergistic effects through alterations to gut microbiota. In this randomized, double-blinded, two-arm feasibility study, we investigated whether intermittent fasting, supplemented with Lacticaseibacillus rhamnosus HN001 probiotic, reduces HbA1c in individuals with prediabetes. All participants with HbA1c 40–50 mmol/mol commenced intermittent fasting (2 days per week of calorie restriction to 600–650 kcal/day) and were randomized 1:1 to either daily probiotic (Lacticaseibacillus rhamnosus HN001) or placebo for 12 weeks. The primary outcome was a change in HbA1c. Secondary outcomes included changes in anthropometry, body composition, glucoregulatory markers, lipids, hunger hormones, liver enzymes, inflammatory markers, gut hormones, calorie and macronutrient intake, quality of life, hunger, mood and eating behavior. Of 33 participants who commenced the trial, 26 participants (mean age 52 years, body mass index (BMI) 34.7 kg/m2) completed the intervention (n = 11 placebo, n = 15 probiotic). HbA1c decreased from 43 ± 2.7 mmol/mol to 41 ± 2.3 mmol/mol, p < 0.001, with average of 5% weight loss. No significant between-group differences were seen in primary or secondary outcomes except for social functioning (p = 0.050) and mental health (p = 0.007) scores as improvements were seen in the probiotic group, but not in the placebo group. This study shows additional psychological benefits of probiotic supplementation during intermittent fasting to achieve weight loss and glycemic improvement in prediabetes.

Probiotics, Pre-biotics and Synbiotics in the Treatment of Pre-diabetes: A Systematic Review of Randomized Controlled Trials

“…Although previous studies have shown that probiotics can improve cholesterol levels in patients with type 2 diabetes (56), they have not been confirmed in patients with pre-diabetes (33,35,38). Naito et al (35) found that after 8 weeks of intervention, the blood lipid level in the probiotics group and the placebo group increased from baseline, and did not return to baseline after elution.…”

“…Meanwhile, homoeostasis model assessment for insulin resistance (HOMA-IR) and β-cell function (HOMA-β) were not found to be different between the probiotics group and the placebo group ( 35 , 54 ). Recently, a study including 26 pre-diabetic patients demonstrated no statistically significant difference observed between the probiotic and placebo groups regarding HbA 1 c, FPG, fasting insulin or c-peptide ( 38 ).…”

Gestational Diabetes, Colorectal Cancer, Bariatric Surgery, and Weight Loss among Diabetes Mellitus Patients: A Mini Review of the Interplay of Multispecies Probiotics

“…[ 25 ]. Tay et al investigated the effect Lacticaseibacillus rhamnosus had among 33 participants with pre-DM [ 26 ]. The probiotic supplement of Lacticaseibacillus rhamnosus , administered for 12 weeks, showed a reduction of most DM-related values, such as haemoglobin A1c and weight, compared to the baseline but not between the intervention and control group.…”

Glycemic Control by Umbilical Cord-Derived Mesenchymal Stem Cells Promotes Effects of Fasting-Mimicking Diet on Type 2 Diabetes

“…FMD has been recently tested in the research of prediabetic and diabetic treatment and has shown immense therapeutic potential particularly for controlling dyslipidemia, but there are still some de ciencies regarding it effects on the glucose metabolism [10,12,15,28]. Here, we investigated the effects of FMD and UC-MSC infusion on DIO type 2 diabetic mice and discovered that FMD indeed reduced weight gain and restored the lipid metabolism, but its capacity of controlling blood glucose was questionable.…”