EndotoxemiaNCT05776329
Dietary Intervention to Reduce Metabolic Endotoxemia
A study testing AIA-D and CONV-D in people with Endotoxemia and Intestinal Microbiota, run by Centro de Investigación en Alimentación y Desarrollo A.C. at 2 sites in Mexico.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Endotoxemia, Intestinal Microbiota, Dietary Habits
- What is being tested?
- AIA-D and CONV-D
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 2 sitesMexico
- Study dates
- 14 Apr 2023to 30 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 11Show fewer
- Present gastrointestinal disease
- Present Coronavirus disease (COVID-19) symptoms
- Develop diseases that affect body weight
- Becoming pregnant
- Withdrawal of informed consent.
Trial locations and contacts
2 sites in 1 country.
Mexico2 sites
Universidad Vizcaya de las Américas
Hermosillo, Sonora, 83240
Centro de Investigación en Alimentación y Desarrollo
Hermosillo, Sonora, 83304
About this study
Official title: Randomized Controlled Clinical Trial on the Anti-inflammatory Effect of a Sustainable Dietary Strategy in Adults With Obesity
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.
Read more
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.
Read the 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
- Being tested
- AIA-D, CONV-D
- Keywords
- Metabolic endotoxemia, Lipopolysaccharide binding protein, Dietary inflammatory index, Planetary health diet
- Medical subject headings
- Endotoxemia, Feeding Behavior, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AIA-DBehavioural
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-DBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: AIA-D |
| General healthy diet recommendations (CONV-D). | Active comparator | The active comparator CONV-D is based on the general healthy diet recommendations Receives: Behavioral: CONV-D |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Baseline to six weeks
Secondary outcomes (10)
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.
Measured: Baseline to six weeks
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).
Measured: Baseline to six weeks
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
Measured: Baseline to six weeks
Change in hip circumference
The hip circumference will be measured using a flexible anthropometric tape (200 cm) at the widest circumference of the gluteus.
Measured: Baseline to six weeks
Change in waist circumference
The waist circumference will be measured using a flexible anthropometric tape (200 cm) at the level of the umbilicus
Measured: Baseline to six weeks
Change in waist-to-hip ratio
The waist-to-hip ratio will be calculated by dividing waist circumference (cm) by hip circumference (cm).
Measured: Baseline to six weeks
Change in percentage of body fat
An electrical bioimpedance analysis device will measure body fat.
Measured: Baseline to six weeks
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.
Measured: Baseline to six weeks
Change in blood pressure
Systolic and diastolic blood pressure will be measured by a digital device.
Measured: Baseline to six weeks
Retention
Percentage of participants that finished the intervention
Measured: Baseline to six weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2023
- Study start14 Apr 2023
- Primary completion30 Jan 2024
- Study completion30 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for EndotoxemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- An interventional randomized controlled clinical trial of parallel design with active control.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centro de Investigación en Alimentación y Desarrollo A.C.
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Silvia Yolanda Moya Camarena, Centro de Investigación en Alimentación y Desarrollo A.C.
- Investigators
- Silvia Y Moya-Camarena, Ph. D., Principal investigator, Centro de Investigación en Alimentación y Desarrollo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05776329
- Sponsor's protocol ID
- SYMC001
- Status last verified
- Feb 2024
- First submitted
- 8 Mar 2023
- Last updated
- 7 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The database will be available from the principal investigator upon reasonable request.
Publications
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.
PubMed 25016597Gray 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.
PubMed 31843036Shivappa 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.
PubMed 23941862Hebert 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.
PubMed 30615051Willett 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.
PubMed 30660336
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Clinical Trial on the Anti-inflammatory Effect of a Sustainable Dietary Strategy in Adults With Obesity
- ClinicalTrials.gov ID
- NCT05776329
- Acronym / sponsor ID
- SYMC001
- Conditions
- Endotoxemia, Intestinal Microbiota, Dietary Habits, Clinical Trial, Obesity
- Keywords
- Metabolic endotoxemia, Lipopolysaccharide binding protein, Dietary inflammatory index, Planetary health diet
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Centro de Investigación en Alimentación y Desarrollo A.C.University, hospital or other
- Study start
- 14 Apr 2023 (actual)
- Primary completion
- 30 Jan 2024 (actual)
- Study completion
- 30 Jan 2024 (actual)
- First posted
- 20 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- An interventional randomized controlled clinical trial of parallel design with active control.
| Arm | Type | Receives |
|---|---|---|
| Low-inflammatory and environmentally friendly dietary strategy (AIA-D) | Experimental | Behavioral: AIA-DThe 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 |
| General healthy diet recommendations (CONV-D). | Active comparator | Behavioral: CONV-DThe active comparator CONV-D is based on the general healthy diet recommendations |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AIA-DThe 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. | Behavioural | Low-inflammatory and environmentally friendly dietary strategy (AIA-D) |
| CONV-DCONV-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. | Behavioural | General healthy diet recommendations (CONV-D). |
Primary outcome
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.
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.
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.
10 secondary outcomes
Change in abundance of Prevotella
Time frame: Baseline to six weeks
Change in body weight
Time frame: Baseline to six weeks
Change in body mass index
Time frame: Baseline to six weeks
Change in hip circumference
Time frame: Baseline to six weeks
Change in waist circumference
Time frame: Baseline to six weeks
Change in waist-to-hip ratio
Time frame: Baseline to six weeks
Change in percentage of body fat
Time frame: Baseline to six weeks
Change in the dietary inflammatory index.
Time frame: Baseline to six weeks
Change in blood pressure
Time frame: Baseline to six weeks
Retention
Time frame: Baseline to six weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2024.
- Background: PubMed 25016597Halmos 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.
- Background: PubMed 31843036Gray 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.
- Background: PubMed 23941862Shivappa 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.
- Background: PubMed 30615051Hebert 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.
- Background: PubMed 30660336Willett 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.
- Individual participant dataSharing planned: No. The database will be available from the principal investigator upon reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Silvia Y Moya-Camarena, Ph. D. principal investigator
Centro de Investigación en Alimentación y Desarrollo
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AIA-D and CONV-D in people with Endotoxemia and Intestinal Microbiota, run by Centro de Investigación en Alimentación y Desarrollo A.C. at 2 sites in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Lipopolysaccharide-binding protein (LBP). (time frame: Baseline to six weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05776329, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2024.