NCT05776329

Dietary Intervention to Reduce Metabolic Endotoxemia

Randomized Controlled Clinical Trial on the Anti-inflammatory Effect of a Sustainable Dietary Strategy in Adults With Obesity

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: Centro de Investigación en Alimentación y Desarrollo A.C. · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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 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.

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 kg/m2) 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 kg/m2) 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 kg/m2) 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 kg/m2) will improve blood pressure more than the general healthy diet recommendations.

Conditions

• Endotoxemia
• Intestinal Microbiota
• Dietary Habits
• Clinical Trial
• Obesity

Interventions

Type	Name	Description
BEHAVIORAL	AIA-D	The total energy contribution (1800 kcal/d) is 20% from protein, 25% from lipids, and 55% from carbohydrates. The recommendations include increasing protein intake primarily from plant sources, limiting the intake of red and processed meat, reducing refined sugar, and moderating dairy consumption. It also includes a list of locally produced and seasonal fruits and vegetables and a list of selected ingredients with anti-inflammatory properties to elaborate their foods. Participants will attend 3 motivational sessions of 1 h every two weeks. Besides nutrition and health, the motivational talks focused on the environmental impact of sustainability. Session 1: Planetary healthy diet. The inflammatory potential of diet. Explanation of the program. Session 2. Effect of ultra-processed food on health. Session 3. Healthy diets. Follow-up information, recipes, and pictures of dishes that meet the given recommendations will be sent once a week through closed social media groups.
BEHAVIORAL	CONV-D	CONV-D is based on general healthy diet recommendations. The total energy contribution (1800 kcal/d) was 20% from protein, 25% from lipids, and 55% from carbohydrates. Among the recommended food groups are fruits (5 times a day), vegetables (5 times a day), cereals (3 times a day), legumes (3 times a day), dairy products (2 times a day), food of animal origin (3 times per day). Participants in the CONV-D group will attend one motivational and nutritional orientation session on day 1 of the intervention. Session 1. Food and nutrition. Obesity and diet. General healthy diet recommendations. Delivery of material (table of food equivalents). Follow-up information will be sent once a week through closed social media groups.

Timeline

• Start date: 2023-04-14
• Primary completion: 2024-01-30
• Completion: 2024-01-30
• First posted: 2023-03-20
• Last updated: 2024-02-07

Locations

2 sites across 1 country: Mexico