Dietary Intervention to Reduce Metabolic Endotoxemia

NCT05776329 | Completed

• 1 other identifier: SYMC001
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 2

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 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.

Conditions

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

Keywords

Metabolic endotoxemia; Lipopolysaccharide binding protein; Dietary inflammatory index; Planetary health diet

Outcome Measures

Primary Outcomes (3)

• Change in Lipopolysaccharide-binding protein (LBP).

  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.

  Baseline to six weeks

• Change in relative abundance of FP

  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.

  Baseline to six weeks

• Change in relative abundance of AM

  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.

  Baseline to six weeks

Secondary Outcomes (10)

• Change in abundance of Prevotella

  Baseline to six weeks

• Change in body weight

  Baseline to six weeks

• Change in body mass index

  Baseline to six weeks

• Change in hip circumference

  Baseline to six weeks

• Change in waist circumference

  Baseline to six weeks

Study Arms (2)

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

EXPERIMENTAL

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

Behavioral: AIA-D

General healthy diet recommendations (CONV-D).

ACTIVE COMPARATOR

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

Behavioral: CONV-D

Interventions

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.

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

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.

General healthy diet recommendations (CONV-D).

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centro de Investigación en Alimentación y Desarrollo A.C.: lead

Study Sites (2)

Universidad Vizcaya de las Américas

Hermosillo, Sonora, 83240, Mexico

Location

Centro de Investigación en Alimentación y Desarrollo

Hermosillo, Sonora, 83304, Mexico

Location

Related Publications (5)

• Halmos EP, Christophersen CT, Bird AR, Shepherd SJ, Gibson PR, Muir JG. Diets that differ in their FODMAP content alter the colonic luminal microenvironment. Gut. 2015 Jan;64(1):93-100. doi: 10.1136/gutjnl-2014-307264. Epub 2014 Jul 12.

  PMID: 25016597 BACKGROUND

• Gray L, Hasebe K, O'Hely M, Ponsonby AL, Vuillermin P, Collier F; BIS Investigator Group. Rapid PCR identification of Prevotella copri in an Australian cohort of pregnant women. J Dev Orig Health Dis. 2020 Jun;11(3):228-234. doi: 10.1017/S2040174419000849. Epub 2019 Dec 17.

  PMID: 31843036 BACKGROUND

• Shivappa N, Steck SE, Hurley TG, Hussey JR, Hebert JR. Designing and developing a literature-derived, population-based dietary inflammatory index. Public Health Nutr. 2014 Aug;17(8):1689-96. doi: 10.1017/S1368980013002115. Epub 2013 Aug 14.

  PMID: 23941862 BACKGROUND

• Hebert JR, Shivappa N, Wirth MD, Hussey JR, Hurley TG. Perspective: The Dietary Inflammatory Index (DII)-Lessons Learned, Improvements Made, and Future Directions. Adv Nutr. 2019 Mar 1;10(2):185-195. doi: 10.1093/advances/nmy071.

  PMID: 30615051 BACKGROUND

• Willett W, Rockstrom J, Loken B, Springmann M, Lang T, Vermeulen S, Garnett T, Tilman D, DeClerck F, Wood A, Jonell M, Clark M, Gordon LJ, Fanzo J, Hawkes C, Zurayk R, Rivera JA, De Vries W, Majele Sibanda L, Afshin A, Chaudhary A, Herrero M, Agustina R, Branca F, Lartey A, Fan S, Crona B, Fox E, Bignet V, Troell M, Lindahl T, Singh S, Cornell SE, Srinath Reddy K, Narain S, Nishtar S, Murray CJL. Food in the Anthropocene: the EAT-Lancet Commission on healthy diets from sustainable food systems. Lancet. 2019 Feb 2;393(10170):447-492. doi: 10.1016/S0140-6736(18)31788-4. Epub 2019 Jan 16. No abstract available.

  PMID: 30660336 BACKGROUND

MeSH Terms

Conditions

Endotoxemia; Feeding Behavior; Obesity

Condition Hierarchy (Ancestors)

Bacteremia; Sepsis; Infections; Toxemia; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior, Animal; Behavior; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms

Study Officials

• Silvia Y Moya-Camarena, Ph. D.

  Centro de Investigación en Alimentación y Desarrollo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Assignor to each group: The assignment of the people to the comparison groups will be carried out by the statistician responsible for the project. The statistician will not participate in any other project stage (registration, intervention, or measurements). Researcher in charge of the database: A person from outside the workgroup will assign codes to the participants enrolled in the study to prevent the person entering the data into the database from identifying the intervention group they belong to. Investigator in charge of the analysis of serum and stool samples: The same codes will be used to label the biological samples so that the person carrying out the interleukin and intestinal microbiota analyses cannot identify the intervention group to which they belong. The keys will be revealed at the end of the statistical analyses.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: An interventional randomized controlled clinical trial of parallel design with active control.

Study Record Dates

• First Submitted: March 8, 2023
• First Posted: March 20, 2023
• Study Start: April 14, 2023
• Primary Completion: January 30, 2024
• Study Completion: January 30, 2024
• Last Updated: February 7, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

ME (2)