Evaluation of the Effect of a Daily Dose of Wakame Seaweed on Reducing Circulating Concentrations of Advanced Glycation End Products in Patients With Stage III Chronic Kidney Disease

NCT07729683 | Recruiting

• 1 other identifier: P02040
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Persistent glomerular hyperfiltration is a characteristic feature of the early stages of kidney disease and represents a factor in the progression of chronic kidney disease (CKD). In this context, the benefit of low-protein diets (less than 0.8g/kg/day) has been demonstrated in slowing the progression of CKD, although the underlying pathophysiological mechanisms remain unclear. Some studies suggest that the effects of protein on renal hemodynamics are primarily linked to the quality of the protein, particularly the amount of AGEs (Advanced Glycation End Products) consumed. Recently, edible seaweeds have gained popularity in Western countries due to their anti-inflammatory, anti-diabetic, and antihypertensive properties. These seaweeds are also associated with the above-average longevity of certain Asian populations who consume them daily. Wakame seaweed (Undaria pinnatifida), which is locally harvested along the French Atlantic coast, has shown promising biological properties, notably antihypertensive and anti-diabetic effects. It has also been recently demonstrated that fucoxanthin, a compound found in high concentrations in wakame, possesses strong anti-AGE activity. Dietary modifications are essential for nephroprotection, but they are often difficult to implement. This highlights the need to develop approaches that are both acceptable on a daily basis and sustainable in the long term for patients. A Michelin-starred chef, known for regularly incorporating seaweed into his cuisine, is a sponsor of the project and has validated a set of adapted recipes that will be offered to participants to accompany the daily wakame supplementation. The investigator's hypothesis is that a daily dose (5 grams of French wakame, dehydrated at low temperature and in flake form), equivalent to the average daily intake in Japan, could reduce circulating AGE levels in patients with stage III CKD. This would provide an additional protective effect when combined with the standard low-protein diet, helping to slow the progression of CKD over the long term.

Conditions

Chronic Kidney Disease

Keywords

Advanced Glycation End Products; AGEs; Chronic kidney disease (CKD); Wakame seaweed

Outcome Measures

Primary Outcomes (1)

• Circulating AGE

  Circulating AGE measurement by plasma methylglyoxal (MG) measurement at M3

  From enrollment to the end of 3 months follow-up

Secondary Outcomes (6)

• Proteinuria

  From enrollment to the end of 3 months follow-up

• Ambulatory blood pressure

  From enrollment to the end of 3 months follow-up

• Plasma creatinine clearance

  From enrollment to the end of 3 months follow-up

• HbA1c

  From enrollment to the end of 3 months follow-up

• Lipid profile

  From enrollment to the end of 3 months follow-up

Study Arms (1)

Experimental group

EXPERIMENTAL

Consumption of 5g/day of wakame (Undoria pinnatifida) during one of the three meals of the day for a period of three months.

Dietary Supplement: Consumption of wakame

Interventions

Consumption of wakame DIETARY_SUPPLEMENT

Consumption of 5g/day of wakame during one of the three meals of the day during three months.

Experimental group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients not under legal protection
• Patients aged ≥ 18 and \< 90 years
• Patients with stage IIIA-B chronic kidney disease (CKD) (estimated GFR by CKD-EPI ≥ 30 mL/min and \< 60 mL/min)
• Patients receiving optimized nephroprotective treatment (ACE inhibitors, SGLT2 inhibitors)
• Patients who have signed the informed consent form
• Patients not participating in another clinical study
• Patients affiliated with or benefiting from a social security scheme

You may not qualify if:

• Adult patients under legal protection
• Patients under 18 years old or over 90 years old
• Patients with uncontrolled thyroid disorders
• Patients with decompensated heart failure
• Patients consuming other dietary supplements containing seaweed or iodine (e.g., multivitamins)
• Pregnant or breastfeeding women
• Patients with acute kidney injury
• Patients who decline to participate in the study

Sponsors & Collaborators

• Groupe Hospitalier de la Rochelle Ré Aunis: lead
• Clinisciences: collaborator

Study Sites (1)

Groupe Hospitalier de La Rochelle Ré Aunis

La Rochelle, 17000, France

RECRUITING

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Gabrielle Laetitia Normand

  Groupe Hospitalier de la Rochelle Ré Aunis

  STUDY DIRECTOR

Central Study Contacts

Cécile Duchiron

CONTACT

+335 46 68 45 67; cecile.duchiron@ght-atlantique17.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2025
• First Posted: July 27, 2026
• Study Start: January 27, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: July 27, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be available immediately following publication
• Access Criteria: Researchers who provide a methodologically sound proposal will have access to the data

Locations

FR (1)