Pigeon Peas (Cajanus Cajan) : a Natural Anti-inflammatory Facilitating Weight Loss in Obese Patients Returning to Sport?

NCT05493592 | Unknown

• 1 other identifier: 19_RIPH2-29
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 1

Brief 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). 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.

Conditions

Severe Obesity

Keywords

Severe obesity; Cajanus cajan (pigeon pea); Physical exercise; NLRP3 inflammasome; French caribbean population

Outcome Measures

Primary Outcomes (1)

• 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.

  Randomization, 6 and 9 months +/- 8 days post randomisation

Secondary Outcomes (12)

• mRNA expression of caspase-1

  Randomization, 6 and 9 months +/- 8 days post randomisation

• mRNA expression of AUC

  Randomization, 6 and 9 months +/- 8 days post randomisation

• mRNA expression of IL-1β

  Randomization, 6 and 9 months +/- 8 days post randomisation

• mRNA expression of IL18

  Randomization, 6 and 9 months +/- 8 days post randomisation

• Plasma level of the pro-inflammatory cytokines IL-1β

  Randomization, 6 and 9 months +/- 8 days post randomisation

Study Arms (2)

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.

Biological: Standardized physical activity protocol associated with the consumption of Cajanus cajan (EXACAJAN)

Interventions

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.

Standardized physical activity protocol associated with the consumption of Cajanus cajan (EXACAJAN)

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Have a BMI ≥ 35 kg/m² (severely obese)
• 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)

You may not qualify if:

• 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
• Taking medication that may affect weight gain (systemic corticosteroids, psychotropic drugs, migraine medications, beta-blockers, chemotherapy, and antibiotics)
• Have a known intolerance to legume seeds
• Have an unbalanced low-calorie diet

Sponsors & Collaborators

• University Hospital Center of Martinique: lead
• GIRCI SOHO: collaborator

Study Sites (1)

CHU de Martinique

Fort-de-France, 97261, Martinique

Location

Related Publications (5)

• 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.

  PMID: 28948512 RESULT

• Gruzdeva 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.

  PMID: 30219068 RESULT

• Pavillard 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.

  PMID: 29588192 RESULT

• Rheinheimer 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.

  PMID: 28764843 RESULT

• Farhat 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.

  PMID: 28493374 RESULT

Related Links

• Obesity and Overweight. WHO 2018
• Thematic files/Environment and health/Esteban
• Overweight and abdominal obesity in Guadeloupe in 2013 - KANNARI survey

MeSH Terms

Conditions

Obesity, Morbid; Motor Activity

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Rémi NEVIERE, MD, PhD

  CHU de Martinique

  STUDY DIRECTOR

Central Study Contacts

Jocelyne CRASPAG, MSc

CONTACT

0596592698; jocelyne.craspag@chu-martinique.fr

Rémi NEVIERE, MD, PhD

CONTACT

0696306410; remi.neviere@chu-martinique.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 5, 2022
• First Posted: August 9, 2022
• Study Start: November 1, 2022
• Primary Completion: November 1, 2024
• Study Completion: September 1, 2025
• Last Updated: August 10, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

MA (1)