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The Promagen Study – Part 1

A randomised controlled study shows supplementation of overweight and obese adults with lactobacilli and bifidobacteria reduces bodyweight and improves well-being

Aim

This randomised, double-blind, placebo controlled study aimed to assess the effect of 6-months supplementation with the Lab4P probiotic on body weight, plasma cholesterol and well-being in healthy overweight and obese individuals.

Method

  • The study was carried out in Sofia, Bulgaria.
  • 220 overweight and obese adults aged 30-65 (BMI 25-34.9, waist circumference >89cm for women or >100cm for men) were divided into two groups.
  • Group 1 took one placebo capsule daily for 6 months.
  • Group 2 received one capsule of 50 billion Lab4P probiotics (Lab4 consortium plus Lactobacillus plantarum CUL66) daily for 6 months.
  • The participants were asked to maintain their normal diet and lifestyle throughout the study.
  • Changes in body weight, BMI, waist circumference, cholesterol levels, incidence of upper respiratory tract infections (URTI) and self-perceived quality of life from the start of the study to 6 months were assessed.

Results

Body weight, BMI and Waist Circumference
  • Compared to placebo (Group 1), Lab4P probiotic supplementation (Group 2) resulted in significant weight loss in:
  • The total population (difference: -1.3kg, ****P<0001)
  • The overweight (BMI 25 to 29.9) participants (difference: -1.4kg, ****P< 0.0001)
    Over 50 year olds (difference: -1.76kg, ***P<001)
    Hypercholesteraemic participants (difference: -2.1kg, ****P<0001)
  • Significant probiotic-mediated reductions in BMI, waist circumference and waist-to-height ratio were also observed in each of the above populations.
  • Greater rates of weight loss were observed in the overweight participants
    (-1.9%, ****P< 0.0001) compared to the obese (-1.2%, *P< 0.05) and in women (-1.6%, ***P< 0.001) compared to men (-1.4%, ****P< 0.0001).

Fig 1: Body weight loss

The Promagen Study - ProVen Probiotics
The Promagen Study - ProVen Probiotics
Plasma LDL-Cholesterol and small dense (sd)LDL-Cholesterol in hypercholesteraemic participants (total cholesterol > 6.2 mmol/l)
  • A significant 8.7% reduction from baseline in plasma LDL-cholesterol (LDL-C) levels was observed in hypercholesterolaemic participants taking Lab4P probiotics (**P=0.0055, Group 2a), while no significant change was found in the placebo subgroup (Group 1a).

Fig 2. Plasma LDL- cholesterol levels in hypercholesterolaemic participants

  • There was a significant 15.2% reduction in the levels of atherogenic small dense LDL-cholesterol (sdLDL-C) in hypercholesterolaemic participants taking Lab4P probiotics (**P=0.0090, Group 2a) when compared to baseline levels. No significant change was found in the placebo subgroup (Group 1a).

Fig 3. Plasma sdLDL- cholesterol levels in hypercholesterolaemic participants

  • There was a significant between group reduction in sdLDL-Cholesterol levels
    (- 17.6%, -0.220 mmol/l, *P=0.0241) favouring the Lab4 probiotic. The plasma LDL-C levels were reduced by 6.59% (-0.305 mmol/l, P=0.1048).

Fig 4. Between group reduction in plasma LDL-C and sdLDL-C levels in hypercholesterolaemic participants

Conclusion

Supplementation of overweight and obese adults with the Lab4P probiotic for 6 months resulted in a significant reduction in body weight in the participants without any lifestyle restrictions. In addition, the incidence of URTI symptoms decreased significantly and the reported Quality of Life improved in response to the probiotic.

Reference

Michael DR et al 2020. A randomised controlled study shows supplementation of overweight and obese adults with lactobacilli and bifidobacteria reduces bodyweight and improves well-being.
Scientific Reports 2020; 10(1): 4183

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