The PROMAGEN Study

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 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.
• One group received the 50 billion Lab4P probiotic product (Lab4 consortium plus Lactobacillus plantarum CUL66) daily for 6 months whilst the second group took a placebo.

• The participants were asked to maintain their normal diet and lifestyle throughout the study.
• Changes in body weight, BMI, waist circumference, the 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, Lab4P probiotic supplementation resulted in significant weight loss in:
– The total population (difference: -1.3kg, ****P< 0.0001)
– The overweight (BMI 25 to 29.9) participants (difference: -1.4kg, ****P< 0.0001)
– Over 50 year olds (difference: -1.76kg, ***P< 0.001)
– Hypercholesteraemic participants (difference: -2.1kg, ****P< 0.0001,
Figure 1)

• 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

Incidence rate of URTI symptoms

• Significant 40% reduction in the incidence of total URTI symptoms in the Lab4P group compared to placebo (****P< 0.0001, Figure 2).
The URTI symptoms were defined as sneezing, cough, sore throat, runny nose and blocked nose).

• 32% significant reduction in the incidence of headache in the Lab4P group compared to placebo (****P< 0.0001, Figure 3).

Fig 2: URTI symptoms

Fig 3: Headaches

Quality of Life assessment at 3 months

• 6.3% significant improvement in General Wellness scores at 3 months
(**P< 0.01) and 5.6% at 6 months (*P< 0.05) in the group supplemented with Lab4P probiotics compared to placebo.

• Significant improvements in scores of State of Health (5.8%, *P< 0.05), State of Energy (5.5%, *P< 0.05) and State of Mood (5.1%,*P< 0.05) were observed at 3 months (Figure 4).

Fig 4: Quality of life

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.
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