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NCT Number: NCT07587918

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

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Low Dietary Acid Load

Other

This arm will follow a DAL lowering diet with the aim to reach <25mEq H⁺/day

Other names: Low Acid Load Diet

Primary outcomes

  1. Percentage change in urinary albumin-to-creatinine ratio (UACR)

    Time frame: Change between baseline and 8 weeks

    Log-transformed urinary albumin-to-creatinine ratio (UACR), following an 8-week dietary intervention.

Secondary outcomes

  1. Change in estimated glomerular filtration rate (eGFR)

    Time frame: Change between baseline and 8 weeks

    eGFR calculated using serum creatinine and/or cystatin C

  2. Change in serum bicarbonate

    Time frame: Change between baseline and 8 weeks

    Serum bicarbonate concentration measured in blood

  3. Change in urinary citrate

    Time frame: Change between baseline and 8 weeks

    Urinary citrate excretion measured in 24-hour urine collections

  4. Glucose response during Oral Glucose Tolerance Test

    Time frame: Change between baseline and 8 weeks

    Area under the curve (AUC) of plasma glucose during oral glucose tolerance test (OGTT)

  5. Change in glucose variability (MAGE)

    Time frame: Change between baseline and 8 weeks

    Mean amplitude of glycemic excursions (MAGE) derived from continuous glucose monitoring (CGM) data.

  6. Change in gut microbiota composition

    Time frame: 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.

  7. Change in serum metabolite profiles

    Time frame: Change between baseline and 8 weeks

    Serum metabolite profiles measured using untargeted metabolomics analysis.

Study contacts

Contact information is provided by the study sponsor or research team.

Ilias Attaye, Dr.

CONTACT

[email protected]

+31 10 704 0704

Sponsors and collaborators

Lead sponsor

Erasmus Medical Center

Other

Registry information

Official study title

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

Acronym: Sweet & Sour

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
May 14, 2026
Registry last updated
May 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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