Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT05405205 |
| Other study ID # |
Slim-LfX2-2021 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
June 8, 2021 |
| Est. completion date |
August 2022 |
Study information
| Verified date |
May 2022 |
| Source |
Slimbiotics GmbH |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
In this placebo-controlled trial the effect of a synbiotic consisting of three different
strains of Lactobacillus fermentum and acacia gum (gum arabic) was compared with a probiotic
formulation containing identical strains on body fat mass, body weight management, traits of
metabolic syndrome and gut permeability in individuals who are abdominally overweight.
Description:
The effects of probiotics on glucose and lipid metabolism, on body fat, weight, visceral fat
and liver steatosis were shown by several meta-analyses for the total variety, as described
above. Some probiotic species/strains, however, seem to be more efficacious (Koutnikova et
al., 2019). The lactobacilli used in this trial were selected for their anti-inflammatory
properties and based on induction of defensins in enterocytes. Therefore, one may expect more
pronounced effects of these strains on traits of the metabolic syndrome, which is driven by
low grade inflammation, than those found in the meta-analyses for the whole variety of
probiotics without discriminating species and strain specificity.
The combination of these Lactobacillus strains with acacia gum is expected to enable even
more pronounce effects, since acacia gum was shown to increase the number of lactobacilli in
the gut (Cherbut et al., 2003; Calame et al., 2008) and, hence, are supposed to promote their
propagation and, hence their effects. The dosage of 10 g/day acacia gum was demonstrated to
be sufficient for enhancing fecal lactobacilli and bifidobacterial (Cherbut et al., 2003;
Calame et al., 2008).
Acacia gum, however, seems to have own effects on traits of the metabolic syndrome. Even
though the effects still need to be confirmed in more DB-RCTs, one may suggest a separate
effect, e.g. by reduction of the SGLT1in the intestine (Nasir et al., 2010).
This DB-RCT aims at providing first evidence for an effect of this symbiotic on traits of the
metabolic syndrome. The target parameters were selected for allowing a health claim according
to the Health Claim Directive of the EU (REGULATION (EC) No 1924/2006 OF THE EUROPEAN
PARLIAMENT AND OF THE COUNCIL of 20 December 2006 on Nutrition and Health Claims Made on
Foods) and/or the REGULATION (EU) No 609/2013 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
of 12 June 2013 for Food for Special Medical Purposes after having confirmative evidence.
The following health claim options are feasible according to the EFSA Guidance on the
scientific requirements for health claims related to appetite ratings, weight management, and
blood glucose concentrations (EFSA Journal 2012;10(3):2604) and to the EFSA Guidance on the
scientific requirements for health claims related to antioxidants, oxidative damage and
cardiovascular health (EFSA Journal 2011;9(12):2474):
- Beneficial effect on long-term glycemia (glucose metabolism) as assessed by HbA1c,
- facilitates weight management as assessed by body weight, BMI, waist circumference, or
body fat mass,
- reduces insulin resistance, a risk factor for type 2 diabetes, as assessed by HOMA-IR,
- reduces LDL-C, a risk factor coronary heart disease,
- increases HDL-C, a beneficial physiological effect. It is noteworthy that EFSA admits
demonstration of effects in type 2 diabetes for health claims on these target parameters
assuming that there is a continuity of these parameters from healthy to impaired
metabolism (EFSA Journal 2012;10(3):2604).
Alternatively, the following claims may be used as FSMPs:
- For dietary management of impaired glucose metabolism and type 2 diabetes
- for dietary weight management in overweight
- for dietary management of insulin resistance The primary parameter has been selected by
estimating the sample size for these potential targets based on the most recent
meta-analysis of Koutnikova et al. 2019. Since we expect a more pronounced effect by the
selected strains and the combination with acacia gum (see above) we assumed a twofold
higher effect than found for the whole variety of probiotics. Taking this into account,
the target parameter with the lowest estimated sample size was body fat in individuals
with type 2 diabetes (N = 56 for each arm). Accordingly, this target was defined as
primary parameter.
