Ignite Creation Date:
2024-05-06 @ 8:25 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06373887
Status:
RECRUITING
Last Update Posted:
2024-04-18
First Post:
2024-04-16
Brief Title:
The Efficacy of Weight-loss Diet Decision-making Based on Initial Gut Metabolic Modules GMMs
Sponsor:
Taipei Veterans General Hospital Taiwan
Organization:
Taipei Veterans General Hospital Taiwan
Study Overview
Official Title:
The Efficacy of Weight-loss Diet Decision-making Based on Initial Gut Metabolic Modules GMMs
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
In recent years the technology to detect the gut microbiomes function has become increasingly developed GMMs are tools GitHub - raeslabGMMs A manually curated database of human gut metabolic modules for describing metabolic pathways for linking microbial metabolic function to species associated with a single metabolite helping to analyze the transcriptional characteristics and metabolic functions of each bacterium and studying their role of the food chain in the ecosystem According to our previous research the group with good weight loss response more than 10 body weight loss in 8 weeks after low-carb diet intervention has higher Shannons diversity and carbohydrate degradation activity test by GMMs implying the deficiency of availability of energy sources may cause more weight changes
Based on the above research we designed a low-carb diet rich in monounsaturated fatty acids and a low-fat diet whole grains with the same calories as a means of weight loss The primary purpose of this study is to evaluate the pre-GMM test for determines the weight loss benefit of the intervention diet Furthermore we try to found the possible mechanism of whether metabolites of microbiota eg SCFA could affect the immune cell change which modulates adipose tissue
Based on the above research we designed a low-carb diet rich in monounsaturated fatty acids and a low-fat diet whole grains with the same calories as a means of weight loss The primary purpose of this study is to evaluate the pre-GMM test for determines the weight loss benefit of the intervention diet Furthermore we try to found the possible mechanism of whether metabolites of microbiota eg SCFA could affect the immune cell change which modulates adipose tissue
Detailed Description:
Many studies have shown that dysbiosis of gut microbiota is related to obesity and metabolic diseases4 Since there are many clinical guidelines for weight loss dietary recommendations that have been developed successful long-term weight loss was still a challenge due to the personal variation of multi-omics markers at baseline and distinct diet-host-microbiome interaction12 A recent study2 related to successful long-term weight loss has found that the baseline microbiota composition and energy utilized patterns are related to the efficacy of long-term weight loss The population with higher respiratory quotient RQ at baseline had significantly more weight loss when participating in a low-carb weight loss diet suggesting that individuals with carbs as their main energy source had greater weight loss benefits when reducing carb sources In our previous study we also found that after the intervention of a low-carb diet LCD the groups with better weight loss results had higher diversity at the baseline and the groups with better weight loss showed more active carbohydrate degradation using gut metabolic modules GMMs analysis In contrast one study5 showed an increased abundance of the genus Dialister encoding carbohydrate-active enzymes gene was associated with unsuccessful body weight loss when intervening with a weight-loss diet enriched with carbohydrates Volumetric Diet According to a recent study2 comparing a low-carb diet LCD and low-fat diet LFD for long-term weight loss the LCD with a higher ratio of monounsaturated fatty acid MUFA saturated fatty acid SFA showed a better weight-loss response while LFD with whole grain carbohydrate had better weight-loss response than refined grain carbohydrate However the weight loss efficacy between two diet arm within people with different carb degradation activities at the baseline was still unclear
So far there are no studies that use microbiota GMMs analysis before deciding which diet to intervene Therefore our study aims to investigate whether pre-examination and then intervention can bring benefits to weight loss efficacy
Before the two dietary interventions fecal microbiota analysis will be conducted to understand the metabolic activity of carbohydrates and then determine whether to enter the low-carbohydrate group or the low-fat group The participants in this study will be divided into two groups one group will have their gut microbiota measured before receiving dietary treatment while the other group will be randomly assigned to one of the two dietary groups Finally the weight loss benefits and changes in gut microbiota and related biochemical data between the two groups will be compared
So far there are no studies that use microbiota GMMs analysis before deciding which diet to intervene Therefore our study aims to investigate whether pre-examination and then intervention can bring benefits to weight loss efficacy
Before the two dietary interventions fecal microbiota analysis will be conducted to understand the metabolic activity of carbohydrates and then determine whether to enter the low-carbohydrate group or the low-fat group The participants in this study will be divided into two groups one group will have their gut microbiota measured before receiving dietary treatment while the other group will be randomly assigned to one of the two dietary groups Finally the weight loss benefits and changes in gut microbiota and related biochemical data between the two groups will be compared
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None