Severe ObesityOBESICANCT05493592
Pigeon Peas (Cajanus Cajan) : a Natural Anti-inflammatory Facilitating Weight Loss in Obese Patients Returning to Sport?
A study testing Standardized physical activity protocol associated with the consumption of Cajanus cajan (EXACAJAN) in people with Severe Obesity, run by University Hospital Center of Martinique at 1 site in Martinique.
Trial summary
Adult obesity is due to an excess of body fat. This corresponds to all the fat in the body (or adipose tissue). It is opposed to the lean mass which corresponds to the weight of muscles, organs and viscera. It is defined from the body mass index (or BMI). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Severe Obesity
- What is being tested?
- Standardized physical activity protocol associated with the consumption of Cajanus cajan (EXACAJAN)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 1 siteMartinique
- Study dates
- Nov 2022to Sep 2025
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have a BMI ≥ 35 kg/m² (severely obese)
- Ability, at the time of inclusion, to follow a personalized physical activity program for 24 weeks.
- Have agreed to follow-up for up to 36 weeks
- Be affiliated to a social security system
- Be able to freely give informed consent (oral)
Who cannot join
- Pregnant woman
- Have a history of type 1 diabetes
- Weight >150 kg (criterion related to the capacity of the exercise bikes used in the study)
- History of renal disease [glomerular filtration < 30 mL/min], cardiovascular history of myocardial ischemia (ECG signs), uncontrolled hypertension [at rest; systolic blood pressure > 140 mm Hg and diastolic blood pressure > 90 mm Hg], heart failure, cardiac valvulopathy, peripheral arterial disease or arteritis, and stroke.
- Have an auto-inflammatory or autoimmune pathology known to modify the expression of NLRP3 (cryopyrinopathies, Crohn's disease, gouty arthritis, chondrocalcinosis, arthritic diseases, type 1 diabetes, Biermer's disease, Basedow's disease, rheumatoid arthritis, systemic lupus erythematosus, sclerodermias, non-alcoholic liver steatosis, multiple sclerosis, Alzheimer's and Parkinson's diseases)
- Have a history of recent (<6 months) infectious disease of viral, parasitic, fungal or bacterial origin known to modify the expression of NLRP3
Show all 12Show fewer
- Taking medication that may affect weight gain (systemic corticosteroids, psychotropic drugs, migraine medications, beta-blockers, chemotherapy, and antibiotics)
- Have completed a personalized physical activity program in the 12 weeks prior to inclusion,
- Have bariatric surgery scheduled within 6 months of inclusion,
- Have a known intolerance to legume seeds
- Have an unbalanced low-calorie diet
- Have consumed dietary supplements containing polyphenols of the flavonoid class (green tea catechins and isoflavones from soy and legume seeds in the 3 months prior to inclusion).
Trial locations and contacts
1 site in 1 country.
Martinique1 site
CHU de Martinique
Fort-de-France, 97261
Cédric FAGOUR, MD, 0596552241 ext. +596, cedric.fagour@chu-martinique.fr
Marie-Elodie JEAN-CHARLES CATAN, MD, 0596552241 ext. +596, marie-elodie.jean-charles-catan@chu-martinique.fr
About this study
Official title: Interest of a Diet Rich in Cajanus Cajan (Pigeon Pea) Associated With a Standardized Exercise Protocol on NLRP3 Inflammasome Expression and Weight Loss in Adult Patients With Severe Obesity.
Adult obesity is due to an excess of body fat. This corresponds to all the fat in the body (or adipose tissue). It is opposed to the lean mass which corresponds to the weight of muscles, organs and viscera. It is defined from the body mass index (or BMI). BMI is calculated by dividing a person's weight by their height squared.
According to these criteria, the prevalence of obesity has reached 17% of the entire adult population in mainland France (ESTENBAN 2015 study). The prevalence figures for obesity in the French overseas departments are higher than in mainland France. The latest epidemiological data available in Martinique and Guadeloupe (KANNARI 2015 study) show that approximately 60% of the adult population is overweight and 25% of the adult population is obese.
Read more
Obesity is considered a chronic disease that increases the risk of cardiovascular and metabolic complications all the more when patients have a BMI ≥ 35 kg/m2, defining severe obesity. When BMI is equal to or exceeds 40 kg/m2, obesity is said to be "morbid" and the risk of cardiovascular complications increases by about 100% to 400% depending on the type of complications. The risk of mortality increases by 50 to 100% compared to the normal weight population.
Obesity and inflammation Adipose tissue accumulates around the abdominal viscera after the fat storage capacity of the subcutaneous territories has been reached. The accumulation of visceral fat is accompanied by a low-grade inflammatory response that is responsible for the secretion of lipid derivatives and mediators toxic to the cardiovascular system and insulin sensitivity. The inflammatory response is characterized by the expression of numerous pro-inflammatory molecules synthesized by adipocytes and immunocompetent single-macrophage cells infiltrating the vascular stroma of adipose tissue. In addition, hyperglycemia and excess lipid intermediates cause the assembly of inflammasomes in the cytosol. Among them, the NLRP3 inflammasome involved in multiple human inflammatory pathologies.
Inflammation opposes weight loss, hence the need to reduce the inflammatory response to facilitate weight loss in obese people.
Pigeon pea, known for its anti-inflammatory properties, is a legume found in Creole gardens and traditionally eaten at Christmas.
The OBESICA study aims at studying the interest of consuming pigeon pea associated with regular physical activity on the inflammatory state of the body and weight loss in obese patients.
Read the detailed description
Obesity is a generic term for excess body fat. In adults, the World Health Organization (WHO) defines overweight and obesity by a body mass index (BMI) ≥ 25 kg/m2 and 30 kg/m2, respectively. According to these criteria, the prevalence of obesity has reached 17% of the entire adult population in France (ESTENBAN 2015 study). Obesity prevalence figures in the French overseas departments are higher than in France : 60% of the adult population in Martinique and Guadeloupe is overweight and 25% of the adult population is obese (KANNARI 2015 study).
Obesity increases the risk of cardiovascular and metabolic complications even more when patients have a BMI ≥ of 35 kg/m2, defining severe obesity. When the BMI is equal to or greater than 40 kg/m2, obesity is said to be "morbid" and the risk of cardiovascular complications increases by between 100% and 400% depending on the type of complications. The risk of mortality increases in the order of 50 to 100% compared to the normal weight population. However, some individuals do not present cardio-metabolic abnormalities despite a significant excess of fat.
Several studies show that cardiovascular and metabolic complications are indeed linked to the accumulation of abdominal visceral fat.
An abdominal girth ≥ 94 cm in men and ≥ 80 cm in women defines abdominal obesity and predicts a high risk of cardiovascular complications. While in France, abdominal obesity affects about 40% of adults, it affects 47% of men and up to 70% of women in overseas territories.
The accumulation of visceral fat is accompanied by a low-grade inflammatory response that is responsible for the secretion of lipid derivatives and mediators that are toxic to the cardiovascular system and insulin sensitivity.
The inflammatory response is characterized by the expression of numerous pro-inflammatory molecules synthesized in particular by adipocytes. In addition to the activation of nuclear transcription factors such as NFκB and AP-1, metabolic danger signals such as hyperglycemia and excess lipid intermediates induce the assembly of multi-protein platforms in the cytosol called inflammasomes including the NLRP3 inflammasome.
Activation of the NLRP3 inflammasome activates caspase-1 which its proteolytic activity is responsible for the release of the cytokines IL-1β and IL-18 into tissue and circulating blood.
Strategies that decrease the inflammatory state and the volume of intra-abdominal fat are a therapeutic goal to limit the occurrence of cardiovascular complications and insulin resistance in the obese.
In this context, it is suggested that reducing the inflammatory response could improve weight loss in obese people. Regular physical activity and a healthy diet have clearly demonstrated anti-inflammatory effects and are effective in weight loss in obese patients.
Several epidemiological and clinical studies highlight the potential "health" effects of molecules with anti-inflammatory and antioxidant properties contained in fruits and vegetables, called phyto-micronutrients. In obese patients, phyto-micronutrients such as certain polyphenols of the flavonoid class are beneficial on plasma markers of inflammation, insulin resistance, lipid profile and weight loss. Among legume seeds, Cajanus cajan or pigeon pea represents an interesting variety because of its high content of non-thermosensitive flavonoids of the isoflavone type (genistein and daidzein). In the French Overseas Departments (DOMs).
We hypothesize that the resumption of adapted physical activity and the reintroduction of polyphenol-rich tropical legume seeds in the diet could bring a benefit in the management of severe obesity in overseas territories by reducing the activation of inflammation mediated by the NLRP3 inflammasome and facilitating the reduction of abdominal visceral fat and weight loss.
- Conditions
- Severe Obesity
- Being tested
- Standardized physical activity protocol associated with the consumption of Cajanus cajan (EXACAJAN)
- Keywords
- Severe obesity, Cajanus cajan (pigeon pea), Physical exercise, NLRP3 inflammasome, French caribbean population
- Medical subject headings
- Obesity, Morbid, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standardized physical activity protocol associated with the consumption of Cajanus cajan (EXACAJAN)Biological
Supervised re-training by an Adapted Physical Activity (APA) professional combined 100 g of pigeon peas 3 times a week
Physical activity protocol is standardized. It's the same than in the control arm.
The preparation of pigeon peas and their consumption will be standardized in terms of species cultivated, geographical origin and culinary preparation.
A follow-up of the food intakes standardized plus follow-up logbook, recording the weekly pigeon pea intake, will also be filled out by the participant. The addition of 100 grams of pigeon peas to the diet corresponds to an intake of about 980 mg of polyphenols, 360 mg of carotenoids and 570 mg of vitamin C (24). Thus, the patient's diet will be fortified with approximately 420 mg of polyphenols per day. This level of polyphenol supplementation is known to have beneficial effects on human health.
| Study group | Role | What they receive |
|---|---|---|
| Standardized physical activity protocol (EXA control group) | No intervention | Physical activity protocol for 24 weeks. Protocol of dietetics and food hygiene for 24 weeks. |
| Standardized physical activity protocol associated with the consumption of Cajanus cajan (EXACAJAN) | Experimental | The EXACAJAN protocol will be continued for 24 weeks. It will combine 3 times a week with 100 grams of pigeon peas in the diet. Protocol of dietetics and food hygiene for 24 weeks. Receives: Biological: Standardized physical activity protocol associated with the consumption of Cajanus cajan (EXACAJAN) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of NLRP3 expression
Basal level variation in mRNA expression of the NLRP3 gene (coding for the NLRP3 protein subunit of the NLRP3 inflammasome), in monocytes isolated from peripheral blood. This variation will be measured by RT-qPCR (Quantitative reverse transcription PCR) and will be expressed in DNA copy number (absolute quantification) using a standard range performed with known quantities of complementary DNA, copies of the RNA of interest.
Measured: Randomization, 6 and 9 months +/- 8 days post randomisation
Secondary outcomes (12)
mRNA expression of caspase-1
The inflammasome NLRP3 is a multi-protein platform (NLRP3, ASC, pro caspase-1) with an active assembly of inflammatory caspases (notably caspase-1) that cleaves the pro-interleukins IL-1β and IL-18 into mature pro-inflammatory cytokines.
The biological evaluation criteria will be the mRNA expression of caspase-1 gene in monocytes isolated from peripheral blood measured in cDNA copy number.
Measured: Randomization, 6 and 9 months +/- 8 days post randomisation
mRNA expression of AUC
The inflammasome NLRP3 is a multi-protein platform (NLRP3, ASC, pro caspase-1) with an active assembly of inflammatory caspases (notably caspase-1) that cleaves the pro-interleukins IL-1β and IL-18 into mature pro-inflammatory cytokines.
The biological evaluation criteria will be the mRNA expression of AUC (apoptotic speck protein containing a caspase recruitment domain) gene in monocytes isolated from peripheral blood measured in cDNA copy number.
Measured: Randomization, 6 and 9 months +/- 8 days post randomisation
mRNA expression of IL-1β
The inflammasome NLRP3 is a multi-protein platform (NLRP3, ASC, pro caspase-1) with an active assembly of inflammatory caspases (notably caspase-1) that cleaves the pro-interleukins IL-1β and IL-18 into mature pro-inflammatory cytokines.
The biological evaluation criteria will be the mRNA expression of IL-1β in monocytes isolated from peripheral blood measured in copy number.
Measured: Randomization, 6 and 9 months +/- 8 days post randomisation
mRNA expression of IL18
The inflammasome NLRP3 is a multi-protein platform (NLRP3, ASC, pro caspase-1) with an active assembly of inflammatory caspases (notably caspase-1) that cleaves the pro-interleukins IL-1β and IL-18 into mature pro-inflammatory cytokines.
The biological evaluation criteria will be the mRNA expression of IL18 in monocytes isolated from peripheral blood measured in copy number.
Measured: Randomization, 6 and 9 months +/- 8 days post randomisation
Plasma level of the pro-inflammatory cytokines IL-1β
The inflammasome NLRP3 is a multi-protein platform (NLRP3, ASC, pro caspase-1) with an active assembly of inflammatory caspases (notably caspase-1) that cleaves the pro-interleukins IL-1β and IL-18 into mature pro-inflammatory cytokines.
The biological evaluation criteria will be the plasma level of the pro-inflammatory cytokines IL-1β measured by ELISA kits in pg/mL.
Measured: Randomization, 6 and 9 months +/- 8 days post randomisation
Plasma level of the pro-inflammatory cytokines IL18
The inflammasome NLRP3 is a multi-protein platform (NLRP3, ASC, pro caspase-1) with an active assembly of inflammatory caspases (notably caspase-1) that cleaves the pro-interleukins IL-1β and IL-18 into mature pro-inflammatory cytokines.
The biological evaluation criteria will be the plasma level of the pro-inflammatory cytokines IL18 measured by ELISA kits in pg/mL.
Measured: Randomization, 6 and 9 months +/- 8 days post randomisation
Plasma level of ultra-sensitive C-reactive Protein
The biological evaluation criteria will be the plasma level of ultra-sensitive C-reactive Protein measured in mg/mL.
Measured: Randomization, 6 and 9 months +/- 8 days post randomisation
Weight loss assessment
Weight measurement in kg
Measured: Randomization, 6 and 9 months +/- 8 days post randomisation
Body mass index assessment
Body mass index measurement
Measured: Randomization, 6 and 9 months +/- 8 days post randomisation
Abdominal perimeter assessment
Abdominal perimeter measurement in centimeters
Measured: Randomization, 6 and 9 months +/- 8 days post randomisation
Hip circumference assessment
Hip circumference measurement in in centimeters
Measured: Randomization, 6 and 9 months +/- 8 days post randomisation
Body composition assessment
Body composition by impedance meter (%)
Measured: Randomization, 6 and 9 months +/- 8 days post randomisation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2022
- Study startNov 2022 (estimated)
- Primary completionNov 2024 (estimated)
- Study completionSep 2025 (estimated)
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 Severe ObesityStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prescription of a standardized 24-week physical activity protocol alone or accompanied by the consumption of 100 grams of pigeon peas (Cajanus cajan) per meal three times a week.
- Masking
- None (open label)
- Enrolment
- 124 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Center of Martinique
- Sponsor type
- University, hospital or other
- Collaborators
- GIRCI SOHO
- Responsible party
- Sponsor
- Investigators
- Rémi NEVIERE, MD, PhD, Study director, CHU de Martinique
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05493592
- Sponsor's protocol ID
- 19_RIPH2-29
- Acronym
- OBESICA
- Status last verified
- Aug 2022
- First submitted
- 5 Aug 2022
- Last updated
- 10 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Shah M, Hurt RT, Mundi MS. Phenotypes of Obesity: How it Impacts Management. Curr Gastroenterol Rep. 2017 Sep 25;19(11):55. doi: 10.1007/s11894-017-0598-1.
PubMed 28948512Gruzdeva O, Borodkina D, Uchasova E, Dyleva Y, Barbarash O. Localization of fat depots and cardiovascular risk. Lipids Health Dis. 2018 Sep 15;17(1):218. doi: 10.1186/s12944-018-0856-8.
PubMed 30219068Pavillard LE, Marin-Aguilar F, Bullon P, Cordero MD. Cardiovascular diseases, NLRP3 inflammasome, and western dietary patterns. Pharmacol Res. 2018 May;131:44-50. doi: 10.1016/j.phrs.2018.03.018. Epub 2018 Mar 26.
PubMed 29588192Rheinheimer J, de Souza BM, Cardoso NS, Bauer AC, Crispim D. Current role of the NLRP3 inflammasome on obesity and insulin resistance: A systematic review. Metabolism. 2017 Sep;74:1-9. doi: 10.1016/j.metabol.2017.06.002. Epub 2017 Jun 11.
PubMed 28764843Farhat G, Drummond S, Al-Dujaili EAS. Polyphenols and Their Role in Obesity Management: A Systematic Review of Randomized Clinical Trials. Phytother Res. 2017 Jul;31(7):1005-1018. doi: 10.1002/ptr.5830. Epub 2017 May 11.
PubMed 28493374
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interest of a Diet Rich in Cajanus Cajan (Pigeon Pea) Associated With a Standardized Exercise Protocol on NLRP3 Inflammasome Expression and Weight Loss in Adult Patients With Severe Obesity.
- ClinicalTrials.gov ID
- NCT05493592
- Acronym / sponsor ID
- OBESICA / 19_RIPH2-29
- Conditions
- Severe Obesity
- Keywords
- Severe obesity, Cajanus cajan (pigeon pea), Physical exercise, NLRP3 inflammasome, French caribbean population
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 124 participants (estimated)
- Lead sponsor
- University Hospital Center of MartiniqueUniversity, hospital or other
- Collaborators
- GIRCI SOHO
- Study start
- Nov 2022 (estimated)
- Primary completion
- Nov 2024 (estimated)
- Study completion
- Sep 2025 (estimated)
- First posted
- 9 Aug 2022 (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.
Adult obesity is due to an excess of body fat. This corresponds to all the fat in the body (or adipose tissue). It is opposed to the lean mass which corresponds to the weight of muscles, organs and viscera. It is defined from the body mass index (or BMI). BMI is calculated by dividing a person's weight by their height squared.
According to these criteria, the prevalence of obesity has reached 17% of the entire adult population in mainland France (ESTENBAN 2015 study). The prevalence figures for obesity in the French overseas departments are higher than in mainland France. The latest epidemiological data available in Martinique and Guadeloupe (KANNARI 2015 study) show that approximately 60% of the adult population is overweight and 25% of the adult population is obese.
Obesity is considered a chronic disease that increases the risk of cardiovascular and metabolic complications all the more when patients have a BMI ≥ 35 kg/m2, defining severe obesity. When BMI is equal to or exceeds 40 kg/m2, obesity is said to be "morbid" and the risk of cardiovascular complications increases by about 100% to 400% depending on the type of complications. The risk of mortality increases by 50 to 100% compared to the normal weight population.
Obesity and inflammation Adipose tissue accumulates around the abdominal viscera after the fat storage capacity of the subcutaneous territories has been reached. The accumulation of visceral fat is accompanied by a low-grade inflammatory response that is responsible for the secretion of lipid derivatives and mediators toxic to the cardiovascular system and insulin sensitivity. The inflammatory response is characterized by the expression of numerous pro-inflammatory molecules synthesized by adipocytes and immunocompetent single-macrophage cells infiltrating the vascular stroma of adipose tissue. In addition, hyperglycemia and excess lipid intermediates cause the assembly of inflammasomes in the cytosol. Among them, the NLRP3 inflammasome involved in multiple human inflammatory pathologies.
Inflammation opposes weight loss, hence the need to reduce the inflammatory response to facilitate weight loss in obese people.
Pigeon pea, known for its anti-inflammatory properties, is a legume found in Creole gardens and traditionally eaten at Christmas.
The OBESICA study aims at studying the interest of consuming pigeon pea associated with regular physical activity on the inflammatory state of the body and weight loss in obese patients.
Detailed description
Obesity is a generic term for excess body fat. In adults, the World Health Organization (WHO) defines overweight and obesity by a body mass index (BMI) ≥ 25 kg/m2 and 30 kg/m2, respectively. According to these criteria, the prevalence of obesity has reached 17% of the entire adult population in France (ESTENBAN 2015 study). Obesity prevalence figures in the French overseas departments are higher than in France : 60% of the adult population in Martinique and Guadeloupe is overweight and 25% of the adult population is obese (KANNARI 2015 study).
Obesity increases the risk of cardiovascular and metabolic complications even more when patients have a BMI ≥ of 35 kg/m2, defining severe obesity. When the BMI is equal to or greater than 40 kg/m2, obesity is said to be "morbid" and the risk of cardiovascular complications increases by between 100% and 400% depending on the type of complications. The risk of mortality increases in the order of 50 to 100% compared to the normal weight population. However, some individuals do not present cardio-metabolic abnormalities despite a significant excess of fat.
Several studies show that cardiovascular and metabolic complications are indeed linked to the accumulation of abdominal visceral fat.
An abdominal girth ≥ 94 cm in men and ≥ 80 cm in women defines abdominal obesity and predicts a high risk of cardiovascular complications. While in France, abdominal obesity affects about 40% of adults, it affects 47% of men and up to 70% of women in overseas territories.
The accumulation of visceral fat is accompanied by a low-grade inflammatory response that is responsible for the secretion of lipid derivatives and mediators that are toxic to the cardiovascular system and insulin sensitivity.
The inflammatory response is characterized by the expression of numerous pro-inflammatory molecules synthesized in particular by adipocytes. In addition to the activation of nuclear transcription factors such as NFκB and AP-1, metabolic danger signals such as hyperglycemia and excess lipid intermediates induce the assembly of multi-protein platforms in the cytosol called inflammasomes including the NLRP3 inflammasome.
Activation of the NLRP3 inflammasome activates caspase-1 which its proteolytic activity is responsible for the release of the cytokines IL-1β and IL-18 into tissue and circulating blood.
Strategies that decrease the inflammatory state and the volume of intra-abdominal fat are a therapeutic goal to limit the occurrence of cardiovascular complications and insulin resistance in the obese.
In this context, it is suggested that reducing the inflammatory response could improve weight loss in obese people. Regular physical activity and a healthy diet have clearly demonstrated anti-inflammatory effects and are effective in weight loss in obese patients.
Several epidemiological and clinical studies highlight the potential "health" effects of molecules with anti-inflammatory and antioxidant properties contained in fruits and vegetables, called phyto-micronutrients. In obese patients, phyto-micronutrients such as certain polyphenols of the flavonoid class are beneficial on plasma markers of inflammation, insulin resistance, lipid profile and weight loss. Among legume seeds, Cajanus cajan or pigeon pea represents an interesting variety because of its high content of non-thermosensitive flavonoids of the isoflavone type (genistein and daidzein). In the French Overseas Departments (DOMs).
We hypothesize that the resumption of adapted physical activity and the reintroduction of polyphenol-rich tropical legume seeds in the diet could bring a benefit in the management of severe obesity in overseas territories by reducing the activation of inflammation mediated by the NLRP3 inflammasome and facilitating the reduction of abdominal visceral fat and weight loss.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prescription of a standardized 24-week physical activity protocol alone or accompanied by the consumption of 100 grams of pigeon peas (Cajanus cajan) per meal three times a week.
| Arm | Type | Receives |
|---|---|---|
| Standardized physical activity protocol (EXA control group) | No intervention | –Physical activity protocol for 24 weeks. Protocol of dietetics and food hygiene for 24 weeks. |
| Standardized physical activity protocol associated with the consumption of Cajanus cajan (EXACAJAN) | Experimental | Biological: Standardized physical activity protocol associated with the consumption of Cajanus cajan (EXACAJAN)The EXACAJAN protocol will be continued for 24 weeks. It will combine 3 times a week with 100 grams of pigeon peas in the diet. Protocol of dietetics and food hygiene for 24 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Have a BMI ≥ 35 kg/m² (severely obese)
- Ability, at the time of inclusion, to follow a personalized physical activity program for 24 weeks.
- Have agreed to follow-up for up to 36 weeks
- Be affiliated to a social security system
- Be able to freely give informed consent (oral)
Key exclusion criteria (12 listed)
- Pregnant woman
- Have a history of type 1 diabetes
- Weight >150 kg (criterion related to the capacity of the exercise bikes used in the study)
- History of renal disease [glomerular filtration < 30 mL/min], cardiovascular history of myocardial ischemia (ECG signs), uncontrolled hypertension [at rest; systolic blood pressure > 140 mm Hg and diastolic blood pressure > 90 mm Hg], heart failure, cardiac valvulopathy, peripheral arterial disease or arteritis, and stroke.
- Have an auto-inflammatory or autoimmune pathology known to modify the expression of NLRP3 (cryopyrinopathies, Crohn's disease, gouty arthritis, chondrocalcinosis, arthritic diseases, type 1 diabetes, Biermer's disease, Basedow's disease, rheumatoid arthritis, systemic lupus erythematosus, sclerodermias, non-alcoholic liver steatosis, multiple sclerosis, Alzheimer's and Parkinson's diseases)
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 |
|---|---|---|
| Standardized physical activity protocol associated with the consumption of Cajanus cajan (EXACAJAN)Supervised re-training by an Adapted Physical Activity (APA) professional combined 100 g of pigeon peas 3 times a week Physical activity protocol is standardized. It's the same than in the control arm. The preparation of pigeon peas and their consumption will be standardized in terms of species cultivated, geographical origin and culinary preparation. A follow-up of the food intakes standardized plus follow-up logbook, recording the weekly pigeon pea intake, will also be filled out by the participant. The addition of 100 grams of pigeon peas to the diet corresponds to an intake of about 980 mg of polyphenols, 360 mg of carotenoids and 570 mg of vitamin C (24). Thus, the patient's diet will be fortified with approximately 420 mg of polyphenols per day. This level of polyphenol supplementation is known to have beneficial effects on human health. | Biological | Standardized physical activity protocol associated with the consumption of Cajanus cajan (EXACAJAN) |
Primary outcome
Assessment of NLRP3 expression
Time frame: Randomization, 6 and 9 months +/- 8 days post randomisation
Basal level variation in mRNA expression of the NLRP3 gene (coding for the NLRP3 protein subunit of the NLRP3 inflammasome), in monocytes isolated from peripheral blood. This variation will be measured by RT-qPCR (Quantitative reverse transcription PCR) and will be expressed in DNA copy number (absolute quantification) using a standard range performed with known quantities of complementary DNA, copies of the RNA of interest.
12 secondary outcomes
mRNA expression of caspase-1
Time frame: Randomization, 6 and 9 months +/- 8 days post randomisation
mRNA expression of AUC
Time frame: Randomization, 6 and 9 months +/- 8 days post randomisation
mRNA expression of IL-1β
Time frame: Randomization, 6 and 9 months +/- 8 days post randomisation
mRNA expression of IL18
Time frame: Randomization, 6 and 9 months +/- 8 days post randomisation
Plasma level of the pro-inflammatory cytokines IL-1β
Time frame: Randomization, 6 and 9 months +/- 8 days post randomisation
Plasma level of the pro-inflammatory cytokines IL18
Time frame: Randomization, 6 and 9 months +/- 8 days post randomisation
Plasma level of ultra-sensitive C-reactive Protein
Time frame: Randomization, 6 and 9 months +/- 8 days post randomisation
Weight loss assessment
Time frame: Randomization, 6 and 9 months +/- 8 days post randomisation
Body mass index assessment
Time frame: Randomization, 6 and 9 months +/- 8 days post randomisation
Abdominal perimeter assessment
Time frame: Randomization, 6 and 9 months +/- 8 days post randomisation
Hip circumference assessment
Time frame: Randomization, 6 and 9 months +/- 8 days post randomisation
Body composition assessment
Time frame: Randomization, 6 and 9 months +/- 8 days post randomisation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2022.
- Results publication: PubMed 28948512Shah M, Hurt RT, Mundi MS. Phenotypes of Obesity: How it Impacts Management. Curr Gastroenterol Rep. 2017 Sep 25;19(11):55. doi: 10.1007/s11894-017-0598-1.
- Results publication: PubMed 30219068Gruzdeva O, Borodkina D, Uchasova E, Dyleva Y, Barbarash O. Localization of fat depots and cardiovascular risk. Lipids Health Dis. 2018 Sep 15;17(1):218. doi: 10.1186/s12944-018-0856-8.
- Results publication: PubMed 29588192Pavillard LE, Marin-Aguilar F, Bullon P, Cordero MD. Cardiovascular diseases, NLRP3 inflammasome, and western dietary patterns. Pharmacol Res. 2018 May;131:44-50. doi: 10.1016/j.phrs.2018.03.018. Epub 2018 Mar 26.
- Results publication: PubMed 28764843Rheinheimer J, de Souza BM, Cardoso NS, Bauer AC, Crispim D. Current role of the NLRP3 inflammasome on obesity and insulin resistance: A systematic review. Metabolism. 2017 Sep;74:1-9. doi: 10.1016/j.metabol.2017.06.002. Epub 2017 Jun 11.
- Results publication: PubMed 28493374Farhat G, Drummond S, Al-Dujaili EAS. Polyphenols and Their Role in Obesity Management: A Systematic Review of Randomized Clinical Trials. Phytother Res. 2017 Jul;31(7):1005-1018. doi: 10.1002/ptr.5830. Epub 2017 May 11.
- Obesity and Overweight. WHO 2018Link provided by the sponsor.
- Overweight and abdominal obesity in Guadeloupe in 2013 - KANNARI surveyLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Rémi NEVIERE, MD, PhD study director
CHU de Martinique
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standardized physical activity protocol associated with the consumption of Cajanus cajan (EXACAJAN) in people with Severe Obesity, run by University Hospital Center of Martinique at 1 site in Martinique.
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 5 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 10 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Martinique. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jocelyne CRASPAG, MSc (0596592698 ext. +596, jocelyne.craspag@chu-martinique.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of NLRP3 expression (time frame: Randomization, 6 and 9 months +/- 8 days post randomisation). 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 NCT05493592, 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 10 Aug 2022.