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NCT Number: NCT05776329

Dietary Intervention to Reduce Metabolic Endotoxemia

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.

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Key information

Conditions

Endotoxemia Bacteremia Behavior Behavior, Animal Body Weight Clinical Trial Dietary Habits Feeding Behavior Infections Inflammation Intestinal Microbiota Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Signs and Symptoms Systemic Inflammatory Response Syndrome Toxemia

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centro de Investigación en Alimentación y Desarrollo, Hermosillo, Sonora, Mexico

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

AIA-D

Behavioral

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.

CONV-D

Behavioral

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.

Primary outcomes

  1. Change in Lipopolysaccharide-binding protein (LBP).

    Time frame: Baseline to six weeks

    Peripheral blood samples will be taken before and after the intervention, centrifuged for serum extraction, and stored at -80°C until analysis. ELISA kits were used to quantify LBP.

  2. Change in relative abundance of FP

    Time frame: Baseline to six weeks

    According to the manufacturer's instructions, total DNA will be extracted from fecal samples and quantified by a spectrophotometer, where the ratio of 1.8-2.0 (260/280) is acceptable. DNA samples will be stored at -80°C until analysis. FP will be amplified from DNA extracted from fecal samples by quantitative polymerase chain reaction (qPCR). A specific set of primers will be used. The relative expression of the gen (relative abundance) will be calculated. The 16S ribosomal RNA (16S) (V4) normalizing gen will be used for analysis.

  3. Change in relative abundance of AM

    Time frame: Baseline to six weeks

    According to the manufacturer's instructions, total DNA will be extracted from fecal samples and quantified by a spectrophotometer, where the ratio of 1.8-2.0 (260/280) is acceptable. DNA samples will be stored at -80°C until analysis. AM will be amplified from DNA extracted from fecal samples by quantitative polymerase chain reaction (qPCR). A specific set of primers will be used. The relative expression of the gen (relative abundance) will be calculated. The 16S ribosomal RNA (16S) (V4) normalizing gen will be used for analysis.

Secondary outcomes

  1. Change in abundance of Prevotella

    Time frame: Baseline to six weeks

    According to the manufacturer's instructions, total DNA will be extracted from fecal samples and quantified by a spectrophotometer, where the ratio of 1.8-2.0 (260/280) is acceptable. DNA samples will be stored at -80°C until analysis. Prevotella will be amplified from DNA extracted from fecal samples by quantitative polymerase chain reaction (qPCR). A specific set of primers will be used. The relative expression of the gen (relative abundance) will be calculated. The 16S ribosomal RNA (16S) (V4) normalizing gen will be used for analysis.

  2. Change in body weight

    Time frame: Baseline to six weeks

    Body weight will be measured with minimal clothing using a digital electronic scale (capacity of 0 to 150 ± 0.05 kg).

  3. Change in body mass index

    Time frame: Baseline to six weeks

    The body mass index will be calculated by dividing the weight (kg) by the square of height (m). Height will be measured using a stadiometer (rank 0.70-2.05 m) while barefoot participants were standing with their heads in the Frankfurt plane

  4. Change in hip circumference

    Time frame: Baseline to six weeks

    The hip circumference will be measured using a flexible anthropometric tape (200 cm) at the widest circumference of the gluteus.

  5. Change in waist circumference

    Time frame: Baseline to six weeks

    The waist circumference will be measured using a flexible anthropometric tape (200 cm) at the level of the umbilicus

  6. Change in waist-to-hip ratio

    Time frame: Baseline to six weeks

    The waist-to-hip ratio will be calculated by dividing waist circumference (cm) by hip circumference (cm).

  7. Change in percentage of body fat

    Time frame: Baseline to six weeks

    An electrical bioimpedance analysis device will measure body fat.

  8. Change in the dietary inflammatory index.

    Time frame: Baseline to six weeks

    The DII and energy-adjusted-DII (E-DII) will be calculated from the dietary data collected using 24-h dietary recall for each participant. E-DII scores were calculated using the density approach wherein all nutrients were converted to 1000 kcal consumption.

  9. Change in blood pressure

    Time frame: Baseline to six weeks

    Systolic and diastolic blood pressure will be measured by a digital device.

  10. Retention

    Time frame: Baseline to six weeks

    Percentage of participants that finished the intervention

Sponsors and collaborators

Lead sponsor

Centro de Investigación en Alimentación y Desarrollo A.C.

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Mar 20, 2023
Registry last updated
Feb 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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