Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05136313 |
| Other study ID # |
1211477 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
June 24, 2022 |
| Est. completion date |
April 2024 |
Study information
| Verified date |
March 2023 |
| Source |
Instituto de Nutrición y Tecnología de los Alimentos |
| Contact |
Mariana Cifuentes, PhD |
| Phone |
56229781428 |
| Email |
mcifuentes[@]inta.uchile.cl |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Obesity-related cardiometabolic diseases are now a leading cause of death worldwide. These
diseases result from a dysfunctional adipose tissue (AT) that induces inflammation, insulin
resistance and altered endocrine function. However, not all obese people develop metabolic
complications, which has given rise to the concept of "metabolically healthy obesity" (MHO).
Recent evidence suggests that intermittent fasting methods, in particular time-restricted
eating (TRE) may be effective in improving cardiometabolic health, independently of weight
loss, and this could be particularly effective in MUO subjects. The investigators hypothesize
that in young male adults TRE is a more effective/beneficial approach in MUO than in MHO due
to the weight loss-independent improvement in their inflammatory and metabolic derangements.
To this aim, a 16-week 8h TRE intervention study will be performed in MHO and MUO subjects,
assessing anthropometric, endocrine, and other outcomes.
Description:
Although clinical differences between metabolically healthy and unhealthy obesity (MHO and
MUO, respectively) have been extensively described, cellular mechanisms involved in these
different phenotypes are largely unknown. This evidence is crucial for proposing preventive
and therapeutic approaches. Recently, intermittent fasting methods, in particular
time-restricted eating (TRE, a self-selected daily limited eating window protocol), have
shown to be effective in improving cardiometabolic health, independently of weight loss,
which could be particularly relevant in MUO.
The investigators will recruit young (20-22y-old) males with obesity (Body Mass Index≥30) and
classify them as MHO or MUO (≤1 or ≥3 metabolic syndrome risk factors, respectively). A
16-week, 8h TRE intervention will be conducted in MHO vs. MUO subgroups, to assess and
compare the anthropometric, metabolic, endocrine, inflammatory and peripheral blood
mononuclear cell (PBMC) mechanistic/signaling response.
The investigators expect to advance the understanding of cellular mechanisms implicated in
MHO and MUO, including potential therapeutic targets. Ultimately, the investigators expect to
find relevant opportunities for intervention to prevent the serious cardiometabolic
consequences of obesity.
