NutrImmune: Precision Nutrition to Improve Immunity in Individuals With Obesity

NCT07850206 | Not Yet Recruiting

• 1 other identifier: C25-106
• Study Type: interventional
• Target: 168
• Locations: 3 countries
• Sites: 4

Brief 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.

Conditions

Obesity (BMI>30); Immune Abnormalities; Low-grade Inflammation

Keywords

Obesity; Immune checkpoint expression; balanced diet; caloric restriction; low-grade inflammation; Microbiome; Glyco-immunomic

Outcome Measures

Primary Outcomes (1)

• Comparison of changes in the percentage of PD-1⁺ CD4⁺ T cells in peripheral blood mononuclear cells between baseline and after 3 month of nutritional intervention

  The first endpoint will be evaluated by calculating the change (Δ) in the percentage of PD-1⁺ CD4⁺ T cells between baseline and month 3 to determine the effect of each nutritional intervention. PBMCs will be isolated from peripheral blood samples locally in each center and then analyzed, centralized by flow cytometry to quantify the percentage of PD-1⁺ CD4⁺ T cells.

  Baseline and 3-months (after the nutritional intervention)

Secondary Outcomes (49)

• Comparison of changes in the percentage of PD-1⁺ CD4⁺ T cells in peripheral blood mononuclear cells between baseline and after 3 month of nutritional intervention and 3 month of follow-up

  Baseline and 6 months (after 3 months of nutritional intervention and 3 months of follow-up)

• Comparison of immune cell phenotyping at baseline, month 3 and month 6 in peripheral blood mononuclear cells between the nutritional interventions

  Between 1) baseline and month 3 (after the nutritional intervention) 2) baseline and month 6 (3 months of nutritional intervention and 3 months of follow-up) and 3) month 3 and month 6

• Comparison of immune checkpoint proteins at baseline, month 3 and month 6 in peripheral blood mononuclear cells between the nutritional interventions

  Between 1) baseline and month 3 (after the nutritional intervention) 2) baseline and month 6 (3 months of nutritional intervention and 3 months of follow-up) and 3) month 3 and month 6

• Comparison of concentration of immunoglobulines G (IgG) in serum at baseline, month 3 and month 6 between the nutritional interventions

  Between 1) baseline and month 3 (after the nutritional intervention) 2) baseline and month 6 (3 months of nutritional intervention and 3 months of follow-up) and 3) month 3 and month 6

• Comparison of cytokines and hsCRP at baseline, month 3 and month 6 in serum between the nutritional interventions

  Between 1) baseline and month 3 (after the nutritional intervention) 2) baseline and month 6 (3 months of nutritional intervention and 3 months of follow-up) and 3) month 3 and month 6

Study Arms (3)

Balanced-Immunity without caloric restriction

EXPERIMENTAL

The intervention will consist of providing personalized nutritional advice through an app called TOUVA, which will offer participants appropriate meal plans (according to their needs, food preferences and usual food consumption) each week during 3 months. The generated menu is based on food group distribution of the EAT- Lancet diet, except for oily fish, which will be set at two servings per week to ensure adequate omega-3 intake.

Other: Mixed test meal; Biological: Biological sampling; Behavioral: Questionnaires; Other: Balanced-immunity diet

Balanced-Immunity with caloric restriction

EXPERIMENTAL

Description: The intervention will consist of providing personalized nutritional advice through an app called TOUVA, which will offer participants appropriate meal plans (according to their needs, food preferences and usual food consumption) with a caloric restriction of 500 kcal/days (based on the evaluation of total energy requirements), each week during 3 months. The generated menu is based on food group distribution of the EAT- Lancet diet, except for oily fish, which will be set at two servings per week to ensure adequate omega-3 intake.

Other: Mixed test meal; Biological: Biological sampling; Behavioral: Questionnaires; Other: Caloric restriction; Other: Balanced-immunity diet

Standard diet with caloric restriction

EXPERIMENTAL

The intervention will consist of providing personalized nutritional advice through an app called TOUVA, which will offer participants appropriate meal plans, according to their needs, food preferences and usual food habits, each week during 3 months. The generated menu has a reduction of 500 kcal/day (based on the evaluation of total energy requirements). The calories reduction will be proportional across all food groups, except for fruits and vegetables, for which intake should remain unchanged.

Other: Mixed test meal; Biological: Biological sampling; Behavioral: Questionnaires; Other: Caloric restriction

Interventions

Mixed test meal OTHER

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.

Balanced-Immunity with caloric restriction; Balanced-Immunity without caloric restriction; Standard diet with caloric restriction

Biological sampling BIOLOGICAL

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.

Balanced-Immunity with caloric restriction; Balanced-Immunity without caloric restriction; Standard diet with caloric restriction

Questionnaires BEHAVIORAL

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.

Balanced-Immunity with caloric restriction; Balanced-Immunity without caloric restriction; Standard diet with caloric restriction

Caloric restriction OTHER

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.

Balanced-Immunity with caloric restriction; Standard diet with caloric restriction

Balanced-immunity diet OTHER

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.

Balanced-Immunity with caloric restriction; Balanced-Immunity without caloric restriction

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≤BMI\<40 kg/m2
• Waist circumference ≥80 cm for women and ≥94 cm for men
• Low-grade inflammatory status, defined as:
• High-sensitive CRP (hsCRP) ≥ 3 mg/L
• Low diet quality: E-DII \> 0, indicating a pro-inflammatory dietary potential
• Affiliation with a social security scheme or beneficiary of such a scheme;
• Effective contraception for women with ability to have children
• Stable weight for at least 3 months (+/- 5% of total body weight)
• In the opinion of the investigator, the subject has adequate support to comply with the entire study requirements as described in the protocol (i.e. ability to move to and from trial site, to understand and fill in the questionnaires, use the app; attend the scheduled visits, full understanding of the protocol)
• Do not follow an exclusive diet (i.e. vegan, vegetarian, or diet without gluten or lactose)
• Living at maximum 1 hour from clinical trial site
• Willingness to not change physical activity level for the whole duration of the study.
• Willingness not to perform any other weight-loss approaches.
• Agreement to adhere to Lifestyle Considerations throughout study duration
• For women of childbearing potential, a negative urinary pregnancy test is required

You may not qualify if:

• Major mental disorders
• Severe eating disorders based on detailed medical history, clinical examination and expertise of the investigating physician, trained in nutrition.
• The use of medication or physical conditions interfering with the study outcomes, at the discretion of the investigating physician
• Allergy or intolerance to any of the components of the study devices and products
• No contraindications to taking oral nutritional supplements, such as severe swallowing disorders or impaired consciousness, and non-functional digestive tract
• Health conditions or treatments interfering with the protocol outcomes or procedure, depending on the situation, postponement of visits may be considered at the discretion of the physicians investigators;
• Withdrawal of consent
• Lost to follow-up

Sponsors & Collaborators

• Amsterdam UMC, location VUmc: collaborator
• University of Hohenheim: collaborator
• University of Bern: collaborator
• Integrative Phenomics: collaborator
• Institut National de la Santé Et de la Recherche Médicale, France: lead
• Sorbonne University: collaborator
• Leibniz Institute for Natural Product Research and Infection Biology Hans Knöll Institute: collaborator

Study Sites (4)

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

Lyon, 69002, France

Location

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

Paris, 75013, France

Location

University of Hohenheim

Stuttgart, 70599, Germany

Location

Amsterdam UMC

Amsterdam, 1105 AZ, Netherlands

Location

Related Links

• Offical website of the NUTRIMMUNE project, providing information about the project objectives, research activities, consortium and participating institutions

MeSH Terms

Conditions

Obesity

Interventions

Surveys and Questionnaires; Caloric Restriction

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Diet Therapy; Nutrition Therapy; Therapeutics; Energy Intake; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Central Study Contacts

Karine CLEMENT

CONTACT

+33 142177928; karine.clement@inserm.fr

Julie-Anne NAZARE

CONTACT

+ 33478863994; julie-anne.nazare@univ-lyon1.fr

Study Design

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

Model Details: This is a controlled, randomized, open-label, parallel-group (3-arm), multicenter clinical study

Study Record Dates

• First Submitted: September 21, 2026
• First Posted: September 30, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): April 1, 2029
• Last Updated: September 30, 2026

Record last verified: 2026-04

Locations

DE (1); NL (1); FR (2)