search
Back to results

Dietary Intervention to Reduce Metabolic Endotoxemia

Primary Purpose

Endotoxemia, Intestinal Microbiota, Dietary Habits

Status
Recruiting
Phase
Not Applicable
Locations
Mexico
Study Type
Interventional
Intervention
AIA-D
CONV-D
Sponsored by
Centro de Investigación en Alimentación y Desarrollo A.C.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Endotoxemia focused on measuring Metabolic endotoxemia, Lipopolysaccharide binding protein, Dietary inflammatory index, Planetary health diet

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts 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.

Sites / Locations

  • Universidad Vizcaya de las AméricasRecruiting
  • Centro de Investigación en Alimentación y DesarrolloRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

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

General healthy diet recommendations (CONV-D).

Arm 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

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

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

Change in abundance of Prevotella
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.
Change in body weight
Body weight will be measured with minimal clothing using a digital electronic scale (capacity of 0 to 150 ± 0.05 kg).
Change in body mass index
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
Change in hip circumference
The hip circumference will be measured using a flexible anthropometric tape (200 cm) at the widest circumference of the gluteus.
Change in waist circumference
The waist circumference will be measured using a flexible anthropometric tape (200 cm) at the level of the umbilicus
Change in waist-to-hip ratio
The waist-to-hip ratio will be calculated by dividing waist circumference (cm) by hip circumference (cm).
Change in percentage of body fat
An electrical bioimpedance analysis device will measure body fat.
Change in the dietary inflammatory index.
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.
Change in blood pressure
Systolic and diastolic blood pressure will be measured by a digital device.
Retention
Percentage of participants that finished the intervention

Full Information

First Posted
March 8, 2023
Last Updated
April 21, 2023
Sponsor
Centro de Investigación en Alimentación y Desarrollo A.C.
search

1. Study Identification

Unique Protocol Identification Number
NCT05776329
Brief Title
Dietary Intervention to Reduce Metabolic Endotoxemia
Official Title
Randomized Controlled Clinical Trial on the Anti-inflammatory Effect of a Sustainable Dietary Strategy in Adults With Obesity
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 14, 2023 (Actual)
Primary Completion Date
September 30, 2023 (Anticipated)
Study Completion Date
August 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centro de Investigación en Alimentación y Desarrollo A.C.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endotoxemia, Intestinal Microbiota, Dietary Habits, Clinical Trial, Obesity
Keywords
Metabolic endotoxemia, Lipopolysaccharide binding protein, Dietary inflammatory index, Planetary health diet

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
An interventional randomized controlled clinical trial of parallel design with active control.
Masking
Outcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Low-inflammatory and environmentally friendly dietary strategy (AIA-D)
Arm Type
Experimental
Arm 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
Arm Title
General healthy diet recommendations (CONV-D).
Arm Type
Active Comparator
Arm Description
The active comparator CONV-D is based on the general healthy diet recommendations
Intervention Type
Behavioral
Intervention Name(s)
AIA-D
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
CONV-D
Intervention Description
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 Outcome Measure Information:
Title
Change in Lipopolysaccharide-binding protein (LBP).
Description
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.
Time Frame
Baseline to six weeks
Title
Change in relative abundance of FP
Description
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.
Time Frame
Baseline to six weeks
Title
Change in relative abundance of AM
Description
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.
Time Frame
Baseline to six weeks
Secondary Outcome Measure Information:
Title
Change in abundance of Prevotella
Description
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.
Time Frame
Baseline to six weeks
Title
Change in body weight
Description
Body weight will be measured with minimal clothing using a digital electronic scale (capacity of 0 to 150 ± 0.05 kg).
Time Frame
Baseline to six weeks
Title
Change in body mass index
Description
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
Time Frame
Baseline to six weeks
Title
Change in hip circumference
Description
The hip circumference will be measured using a flexible anthropometric tape (200 cm) at the widest circumference of the gluteus.
Time Frame
Baseline to six weeks
Title
Change in waist circumference
Description
The waist circumference will be measured using a flexible anthropometric tape (200 cm) at the level of the umbilicus
Time Frame
Baseline to six weeks
Title
Change in waist-to-hip ratio
Description
The waist-to-hip ratio will be calculated by dividing waist circumference (cm) by hip circumference (cm).
Time Frame
Baseline to six weeks
Title
Change in percentage of body fat
Description
An electrical bioimpedance analysis device will measure body fat.
Time Frame
Baseline to six weeks
Title
Change in the dietary inflammatory index.
Description
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.
Time Frame
Baseline to six weeks
Title
Change in blood pressure
Description
Systolic and diastolic blood pressure will be measured by a digital device.
Time Frame
Baseline to six weeks
Title
Retention
Description
Percentage of participants that finished the intervention
Time Frame
Baseline to six weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Silvia Y Moya-Camarena, Ph. D.
Phone
+526622969249
Ext
322
Email
moyas@ciad.mx
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Silvia Y Moya-Camarena, Ph. D.
Organizational Affiliation
Centro de Investigación en Alimentación y Desarrollo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universidad Vizcaya de las Américas
City
Hermosillo
State/Province
Sonora
ZIP/Postal Code
83240
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
María F Delgado-Gaytán, Ph. D.
Phone
+526624199029
Email
salud_hermosillo@uva.edu.mx
Facility Name
Centro de Investigación en Alimentación y Desarrollo
City
Hermosillo
State/Province
Sonora
ZIP/Postal Code
83304
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Héctor D Parra-Sánchez, Ph. D.
Phone
+526622892400
Ext
319
Email
hector.parra@ciad.mx

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
The database will be available from the principal investigator upon reasonable request.
Citations:
PubMed Identifier
25016597
Citation
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.
Results Reference
background
PubMed Identifier
31843036
Citation
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.
Results Reference
background
PubMed Identifier
23941862
Citation
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.
Results Reference
background
PubMed Identifier
30615051
Citation
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.
Results Reference
background
PubMed Identifier
30660336
Citation
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. Erratum In: Lancet. 2019 Feb 9;393(10171):530. Lancet. 2019 Jun 29;393(10191):2590. Lancet. 2020 Feb 1;395(10221):338. Lancet. 2020 Oct 3;396(10256):e56.
Results Reference
background

Learn more about this trial

Dietary Intervention to Reduce Metabolic Endotoxemia

We'll reach out to this number within 24 hrs