Dietary Intervention to Reduce Metabolic Endotoxemia

Centro de Investigación en Alimentación y Desarrollo A.C.

Status: Completed

Conditions: Dietary Habits; Intestinal Microbiota; Obesity; Clinical Trial; Endotoxemia

Treatments: Behavioral: CONV-D; Behavioral: AIA-D

Study type: Interventional

Funder types: Other

Identifiers

NCT05776329

SYMC001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 72 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• Clinically diagnosed with hyperglycemia, hypertension, cardiovascular disease, renal disease, hepatic disease, immunosuppression, or another metabolic disease.
• 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 under treatment with antibiotics or anti-inflammatory drugs in the last three months.
• Having bariatric surgery.
• Being pregnant or lactating.
• Present gastrointestinal disease
• Present Coronavirus disease (COVID-19) symptoms
• Develop diseases that affect body weight
• Becoming pregnant
• Withdrawal of informed consent.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

72 participants in 2 patient groups

Low-inflammatory and environmentally friendly dietary strategy (AIA-D)

Experimental group

Description:

The environmentally friendly dietary strategy (AIA-D) designed based on the planetary health diet recommendations translated to the regional context and includes nutrients related to anti-inflammatory responses

Treatment:

Behavioral: AIA-D

General healthy diet recommendations (CONV-D).

Active Comparator group

Description:

The active comparator CONV-D is based on the general healthy diet recommendations

Treatment:

Behavioral: CONV-D