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Sweet & Sour: Dietary Acid Load in Type 2 Diabetes and Kidney Disease Across Sex and Ethnic Groups (Sweet & Sour)

7. maj 2026 opdateret af: Ilias Attaye, MD, PhD, Erasmus Medical Center

Sweet & Sour: Exploring Dietary Acid Load in Type 2 Diabetes & Kidney Disease Across Sex and Ethnicity

Chronic kidney disease (CKD) is a common condition and a major global cause of illness and mortality. The most common cause of kidney damage is diabetes, a condition that disrupts metabolism, leading to increased risk of damage to the kidneys and blood vessels. There is evidence suggesting that a diet with high acid load - consisting of acid-forming foods such as meat, cheese, and grain products - may contribute to this damage. People with such a diet often have poorer blood sugar control and more kidney damage. However, it is not yet well understood whether reducing dietary acid load can improve kidney function and diabetes management. Additionally, the role of ethnicity and sex in this process remains insufficiently explored.

The goal of this clinical trial is to understand how diet affects kidney function and blood sugar regulation in individuals with diabetes type 2 and chronic kidney disease, as well as to explore the role of sex and ethnicity in these effects. The main questions it aims to answer are:

Does a diet with lower acid load (e.g. less meat, cheese, and grain products) improve kidney function and blood sugar regulation in people with diabetes type 2 and chronic kidney disease?

Does the effect of diet on kidney function and blood sugar differ between ethnic groups, specifically between White-Dutch and South-Asian Surinamese descent people?

Participants will:

  • be randomly assigned to follow either a high- or low-acid load diet for 8 weeks;
  • Visit the study center four times (including screening)
  • Complete food diaries three times per week and keep in regular contact with a dietitian;
  • Collect 2x24-hour urine samples and morning feces at each visit ;
  • Undergo blood sampling and an oral glucose tolerance test (OGTT).
  • Spend a total of 8 hours at the study center (2 visits of 3 hours for OGTT and body composition tests, and 2 visits of 1 hour for additional assessments);
  • Have up to 200 ml of blood collected during the study.

Studieoversigt

Status

Ikke rekrutterer endnu

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

80

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

      • Rotterdam, Holland
        • Erasmus Medical Center
        • Kontakt:
        • Ledende efterforsker:
          • Ilias Attaye, Dr.
        • Underforsker:
          • Dagmar Dekker, MSc

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

  • Age >18 years
  • Presence of T2D and CKD stage G1-3a with albuminuria (>10mg/mmol)
  • BMI≥ 25kg/m2 - Use of metformin on a stable dose (i.e. no changes in the last three months)
  • Adequate knowledge of the Dutch language to comprehend the provided study information
  • If incretin therapy is used, then subject must have used that for a minimum of 6 months before starting with the trial
  • Use of ACE inhibitors or angiotensin II receptor blokkers
  • Of white European Dutch or South-Asian Surinamese descent

Exclusion Criteria:

  • Use of insulin
  • serum bicarbonate < 20 mmol/L
  • Use of antibiotics 3 months before inclusion
  • Vegetarian diet - Presence of inflammatory bowel disease or other chronic inflammatory disease
  • Alcohol consumption of more than 14 units per week in women, or more than 21 units per week in men
  • Active malignancy - bariatric or other weight loss surgery in the history
  • patients diagnosed with eating disorders (such as bulimia nervosa, anorexia nervosa or binge-eating disorder)
  • HbA1c >9% (75mmol/mol) at screening
  • Unmotivated or not able to adhere to a specific diet
  • The subject is already currently involved in a clinical trial

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Ingen indgriben: High Dietary Acid Load
This arm will follow their usual diet, which is between DAL> 50 or <120mEq H⁺/day (current western diets are generally all high DAL)
Eksperimentel: Low Dietary Acid Load
This arm will follow a DAL lowering diet with the aim to reach <25mEq H⁺/day
This arm will follow a DAL lowering diet with the aim to reach <25mEq H⁺/day
Andre navne:
  • Low Acid Load Diet

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Percentage change in urinary albumin-to-creatinine ratio (UACR)
Tidsramme: Change between baseline and 8 weeks
Log-transformed urinary albumin-to-creatinine ratio (UACR), following an 8-week dietary intervention.
Change between baseline and 8 weeks

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in estimated glomerular filtration rate (eGFR)
Tidsramme: Change between baseline and 8 weeks
eGFR calculated using serum creatinine and/or cystatin C
Change between baseline and 8 weeks
Change in serum bicarbonate
Tidsramme: Change between baseline and 8 weeks
Serum bicarbonate concentration measured in blood
Change between baseline and 8 weeks
Change in urinary citrate
Tidsramme: Change between baseline and 8 weeks
Urinary citrate excretion measured in 24-hour urine collections
Change between baseline and 8 weeks
Glucose response during Oral Glucose Tolerance Test
Tidsramme: Change between baseline and 8 weeks
Area under the curve (AUC) of plasma glucose during oral glucose tolerance test (OGTT)
Change between baseline and 8 weeks
Change in glucose variability (MAGE)
Tidsramme: Change between baseline and 8 weeks
Mean amplitude of glycemic excursions (MAGE) derived from continuous glucose monitoring (CGM) data.
Change between baseline and 8 weeks
Change in gut microbiota composition
Tidsramme: Change between baseline and 8 weeks
Gut microbiota composition assessed in morning fecal samples collected using stool collection kits analyzed by 16S rRNA gene sequencing.
Change between baseline and 8 weeks
Change in serum metabolite profiles
Tidsramme: Change between baseline and 8 weeks
Serum metabolite profiles measured using untargeted metabolomics analysis.
Change between baseline and 8 weeks

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Ledende efterforsker: Ilias Attaye, Dr., Erasmus Medical Center

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. juni 2026

Primær færdiggørelse (Anslået)

1. juni 2028

Studieafslutning (Anslået)

1. juni 2028

Datoer for studieregistrering

Først indsendt

22. april 2026

Først indsendt, der opfyldte QC-kriterier

7. maj 2026

Først opslået (Faktiske)

14. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

14. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

7. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

Publication will be open access. All data is available upon resonable request from the Principal Investigator. Of note: All data will be pseudoanonymzed.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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Kliniske forsøg med Low Dietary Acid Load

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