NCT02667691

Evaluation of SODB® in Metabolic Adaptations in Overweight Women

Evaluation of SODB®, Associated With a Caloric Restriction, in Metabolic Adaptations in Overweight Women: Randomized Double-blind Study Versus Placebo

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 32 (estimated)
• Sponsor: Bionov · Industry
• Sex: Female
• Age: 25 Years – 50 Years
• Healthy volunteers: Accepted

Summary

The objective of this study is to evaluate the influence of a 3 months SODB® supplementation in adipose tissue modulations of overweight women, in comparison to a placebo.

Detailed description

Beneficial experimental results have already been obtained with SODB®. That is why, the investigators expect several effects of SODB® here. Indeed, this clinical study could show that SODB® is able to induce endogenous antioxidant defence, and then reduce oxidative stress generally observed in overweight adipose tissue. Moreover, this study could evaluate the impact of a decrease in oxidative stress on the others overweight-induced disorders, such as insulin resistance, inflammation, fibrosis, lipolyse alterations.

Conditions

• Overweight

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	SODB Dimpless	Subjects are supplemented with SODB, daily over 3 Months. Each volunteer was seen for the 4 visits: - visit of pre-inclusion, - visit V1, so-called inclusion visit, - visit V2 at 1,5 months and - visit V3 at 3 months
DIETARY_SUPPLEMENT	Placebo	Subjects are supplemented with placebo, daily over 3 Months. Each volunteer was seen for the 4 visits: - visit of pre-inclusion, - visit V1, so-called inclusion visit, - visit V2 at 1,5 months and - visit V3 at 3 months
OTHER	caloric restriction	Caloric recommendation reduced by 20%

Timeline

• Start date: 2016-02-01
• Primary completion: 2017-05-01
• Completion: 2018-01-01
• First posted: 2016-01-29
• Last updated: 2016-01-29