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NOT YET RECRUITING
NCT07850206
NA

NutrImmune: Precision Nutrition to Improve Immunity in Individuals With Obesity

Sponsor: Institut National de la Santé Et de la Recherche Médicale, France

View on ClinicalTrials.gov

Summary

Obesity is a complex health condition defined by the World Health Organization (WHO) as an excess of body weight that may be harmful to health. It leads to other diseases such as type 2 diabetes or cardiovascular diseases, commonly referred to as "co-morbidities." Among these, it is known that obesity increases the risk of developing infectious diseases and of these diseases progressing to severe stages. During the COVID-19 pandemic and the 2009 H1N1 influenza epidemic, a rise in severe infection cases was observed in people with obesity. A part of people with obesity exhibits certain markers on the surface of their immune cells, which are known to cause immunosuppression when present in high numbers, thus increasing the risk of developing infectious diseases. Investigator teams found that after bariatric surgery and a calorie-restricted diet for weight loss, patients with obesity can improve the levels of these immunity-related markers. Moreover, the choice of foods consumed contributes to strengthening the immune system and immune functions of individuals, both directly by influencing inflammation and indirectly through the microbiota. However, to date, there are no dietary recommendations specifically designed to help people with obesity improve their immune response. Therefore, this study aims to compare different dietary recommendations intended to improve immune status, with or without calorie restriction, during 3 months, in individuals with obesity (BMI ≥ 30 kg/m²) and impaired immunity. Over 6 months (3 months of nutritional intervention and 3 months of follow-up), investigators will collect extensive information through biological samples, measurements and questionnaires to compare the different dietary interventions studied and to understand the mechanisms behind the results obtained.

Official title: NutrImmune: Precision Nutrition to Improve Immunity in Individuals With Obesity - a Randomized Controlled Study

Key Details

Gender

All

Age Range

40 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

168

Start Date

2026-10-01

Completion Date

2029-04

Last Updated

2026-09-30

Healthy Volunteers

No

Interventions

OTHER

Mixed test meal

A mixed test meal, rich in glucose and lipids will be served to the participant during baseline, 3 months and 6 months visits. The participant will have 10 minutes to eat it, and then blood will be sampled during the 4 hours following ingestion of the meal-test. The test meal must be consumed within 10 minutes in order to ensure standardized ingestion conditions between individuals and to limit biases linked to different ingestion times, which could subsequently alter the kinetics of biomarkers measured following meal ingestion. This will allow us to describe the postprandial excursions in glucose, triglycerides and insulin with indicators of the curve as amplitude, pick or time to return to baseline. These indicators are early markers of cardio-metabolic risk alterations. A biobanking of samples is also performed.

BIOLOGICAL

Biological sampling

Changes in biological parameters will be assessed based on samples collected before the baseline, 3-month and 6-month visits (maximum 2 days before each visit) for feces, and during visits for blood and adipose tissue.

BEHAVIORAL

Questionnaires

In order to assess some of the secondary outcomes, participants will be asked to fill in the following questionnaires : 3 24h-recall and validated Food Frequency questionnaire (FFQ), TEFQ, Baecke, Bristol, GSRS, SF12, IWQOL, PSS, PHQ-9, GSES, PSQI, MAUQ and CSQ-8.

OTHER

Caloric restriction

Participants will be placed on a calorie-restricted diet with a reduction of 500 kcal/day (calculated based on total energy requirement) during 3 months. The calories reduction will be proportional across all food groups, except for fruits and vegetables, for which intake will remain unchanged.

OTHER

Balanced-immunity diet

The intervention consists of delivering the diet previously defined as the "Balanced-Immunity" diet in the form of meal plan and menus, accessible via TOUVA, a dedicated application during 3 months.

Locations (4)

Hospices Civils de Lyon et Centre de Recherche en Nutrition Humaine Rhône-Alpes

Lyon, France

Clinical Investigation Center Pitié-Paris Est and Nutrition dpt. Hôpital Pitié-Salpêtrière, Sorbonne Université, Paris

Paris, France

University of Hohenheim

Stuttgart, Germany

Amsterdam UMC

Amsterdam, Netherlands