NCT05776329Completed
Dietary Intervention to Reduce Metabolic Endotoxemia
Randomized Controlled Clinical Trial on the Anti-inflammatory Effect of a Sustainable Dietary Strategy in Adults With Obesity
Source: ClinicalTrials.gov · Last updated 7 Feb 2024
Brief summary (registry, in English)
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 kg/m2). 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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 72 (actual)
- First submitted
- 8 Mar 2023
- Start date
- 14 Apr 2023
- Primary completion date
- 30 Jan 2024
- Lead sponsor
- Centro de Investigación en Alimentación y Desarrollo A.C.
- Diseases
- Obesity
- NCT number
- NCT05776329
What you commit to
- Study type: Interventional
- Participants enrolled: 72
- From 14 Apr 2023 to the primary completion date, 30 Jan 2024
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Being under treatment with antibiotics or anti-inflammatory drugs in the last three months.
- Having bariatric surgery.
Other illness
- Clinically diagnosed with hyperglycemia, hypertension, cardiovascular disease, renal disease, hepatic disease, immunosuppression, or another metabolic disease.
- Present gastrointestinal disease
- Present Coronavirus disease (COVID-19) symptoms
- Develop diseases that affect body weight
Other
- Being under a dietary restriction regimen or pharmacological treatment to lose weight.
- Consuming dietary supplements for at least six months (vitamins, fatty acids, probiotics, prebiotics).
- Being pregnant or lactating.
- Becoming pregnant
- Withdrawal of informed consent.
Who the study is looking for
- Obesity according to body mass index: ≥ 30 kg/m2
- Willingness to participate and sign the consent form.
- Willingness to follow the dietary recommendations of the protocol.
- Have access to the internet and an electronic device.
Age in the registry: 18 years to 50 years · Sex: All · Accepts healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Centro de Investigación en Alimentación y Desarrollo Coordinator of this site? Confirm its status | Hermosillo | Mexico | Unknown status |
| Universidad Vizcaya de las Américas Coordinator of this site? Confirm its status | Hermosillo | Mexico | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.