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

7. mai 2026 oppdatert av: 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.

Studieoversikt

Status

Har ikke rekruttert ennå

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

80

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

      • Rotterdam, Nederland
        • Erasmus Medical Center
        • Ta kontakt med:
        • Hovedetterforsker:
          • Ilias Attaye, Dr.
        • Underetterforsker:
          • Dagmar Dekker, MSc

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Forebygging
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Ingen inngripen: 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)
Eksperimentell: 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 navn:
  • Low Acid Load Diet

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Etterforskere

  • Hovedetterforsker: Ilias Attaye, Dr., Erasmus Medical Center

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. juni 2026

Primær fullføring (Antatt)

1. juni 2028

Studiet fullført (Antatt)

1. juni 2028

Datoer for studieregistrering

Først innsendt

22. april 2026

Først innsendt som oppfylte QC-kriteriene

7. mai 2026

Først lagt ut (Faktiske)

14. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

14. mai 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

7. mai 2026

Sist bekreftet

1. mai 2026

Mer informasjon

Begreper knyttet til denne studien

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (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.

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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