Ignite Creation Date:
2024-05-06 @ 6:46 PM
Last Modification Date:
2024-10-26 @ 2:54 PM
Study NCT ID:
NCT05776329
Status:
COMPLETED
Last Update Posted:
2024-02-07
First Post:
2023-03-08
Brief Title:
Dietary Intervention to Reduce Metabolic Endotoxemia
Sponsor:
Centro de Investigación en Alimentación y Desarrollo AC
Organization:
Centro de Investigación en Alimentación y Desarrollo AC
Study Overview
Official Title:
Randomized Controlled Clinical Trial on the Anti-inflammatory Effect of a Sustainable Dietary Strategy in Adults With Obesity
Status:
COMPLETED
Status Verified Date:
2024-02
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:
The goal of this randomized clinical trial is to compare an antiinflammatory and environmentally friendly dietary strategy AIA-D designed based on the planetary health diet recommendations translated to the regional context and including nutrients related to antiinflammatory responses with an active control diet based on general healthy diet recommendations CONV-D in adults from 18 to 50 years of age with obesity body mass index 30 kgm2 The main questions it aims to answer are
If the intervention with AIA-D will cause a significant decrease at the end of the intervention six weeks in lipopolysaccharide-binding protein LBP compared to CONV-D
If intervention with AIA-D will cause a significant increase at the end of the intervention six weeks in the relative abundance of two specific bacteria genera AM and FP when compared to CONV-D
Participants will
Sign the informed consent
Provide two peripheral blood samples taken by our trained professionals
Provide two samples of feces
Allow anthropometric body weight height hip and waist circumferences blood pressure measurements on two occasions
Respond to 24 h dietary recall on two occasions
Attend the 1-hour group sessions requested three for AIA-D and one for CONV-D
Follow the dietary recommendations provided
Be willing to participate in social media groups to receive information and follow up during the six weeks of the intervention
Researchers will compare an antiinflammatory and environmentally friendly strategy AIA-D with an active control diet CONV-D based on general healthy diet recommendations to see if AIA-D decreases metabolic endotoxemia measured through LBP serum levels and increase the relative abundance of AM and FP compared to CONV-D
If the intervention with AIA-D will cause a significant decrease at the end of the intervention six weeks in lipopolysaccharide-binding protein LBP compared to CONV-D
If intervention with AIA-D will cause a significant increase at the end of the intervention six weeks in the relative abundance of two specific bacteria genera AM and FP when compared to CONV-D
Participants will
Sign the informed consent
Provide two peripheral blood samples taken by our trained professionals
Provide two samples of feces
Allow anthropometric body weight height hip and waist circumferences blood pressure measurements on two occasions
Respond to 24 h dietary recall on two occasions
Attend the 1-hour group sessions requested three for AIA-D and one for CONV-D
Follow the dietary recommendations provided
Be willing to participate in social media groups to receive information and follow up during the six weeks of the intervention
Researchers will compare an antiinflammatory and environmentally friendly strategy AIA-D with an active control diet CONV-D based on general healthy diet recommendations to see if AIA-D decreases metabolic endotoxemia measured through LBP serum levels and increase the relative abundance of AM and FP compared to CONV-D
Detailed Description:
This randomized clinical trial proposes to evaluate an environmentally friendly dietary strategy AIA-D designed based on the planetary health diet recommendations translated to the regional context and including nutrients related to anti-inflammatory responses that can decrease metabolic endotoxemia and promote FP and AM growth associated with anti-inflammatory effects and good intestinal health compared to an active control diet CONV-D general healthy diet recommendations
Primary hypothesis The intervention with a low-inflammatory and environmentally friendly dietary strategy aimed at adults diagnosed with obesity body mass index 30 kgm2 will cause a significant decrease at the end of the intervention six weeks in the levels of lipopolysaccharide-binding protein metabolic endotoxemia and significantly increase the relative abundance of AM and FP when compared to general healthy diet recommendations
Secondary hypotheses The intervention with a low-inflammatory and environmentally friendly dietary strategy aimed at adults diagnosed with obesity body mass index 30 kgm2 will cause a significant increase at the end of the intervention six weeks in the relative abundance of Prevotella when compared to general healthy diet recommendations
The intervention with a low-inflammatory and environmentally friendly dietary strategy aimed at adults diagnosed with obesity body mass index 30 kgm2 will cause a significant decrease at the end of the intervention six weeks of body weight percentage of body fat body mass index circumferences of waist and hip when compared to general healthy diet recommendations
The intervention with a low-inflammatory and environmentally friendly dietary strategy aimed at adults diagnosed with obesity body mass index 30 kgm2 will improve blood pressure more than the general healthy diet recommendations
Primary hypothesis The intervention with a low-inflammatory and environmentally friendly dietary strategy aimed at adults diagnosed with obesity body mass index 30 kgm2 will cause a significant decrease at the end of the intervention six weeks in the levels of lipopolysaccharide-binding protein metabolic endotoxemia and significantly increase the relative abundance of AM and FP when compared to general healthy diet recommendations
Secondary hypotheses The intervention with a low-inflammatory and environmentally friendly dietary strategy aimed at adults diagnosed with obesity body mass index 30 kgm2 will cause a significant increase at the end of the intervention six weeks in the relative abundance of Prevotella when compared to general healthy diet recommendations
The intervention with a low-inflammatory and environmentally friendly dietary strategy aimed at adults diagnosed with obesity body mass index 30 kgm2 will cause a significant decrease at the end of the intervention six weeks of body weight percentage of body fat body mass index circumferences of waist and hip when compared to general healthy diet recommendations
The intervention with a low-inflammatory and environmentally friendly dietary strategy aimed at adults diagnosed with obesity body mass index 30 kgm2 will improve blood pressure more than the general healthy diet recommendations
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