Type 2 DiabetesSweet & SourNCT07587918
Sweet & Sour: Dietary Acid Load in Type 2 Diabetes and Kidney Disease Across Sex and Ethnic Groups
A study testing Low Dietary Acid Load in people with Type 2 Diabetes and Chronic Kidney Disease, run by Erasmus Medical Center at 1 site in Netherlands.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes, Chronic Kidney Disease
- What is being tested?
- Low Dietary Acid Load
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Jun 2026to 1 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site
Erasmus Medical Center
Rotterdam
Ilias Attaye, Dr., +31 10 704 0704, i.attaye@erasmusmc.nl
Ilias Attaye, Dr.
About this study
Official title: 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:
Read more
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.
- Conditions
- Type 2 Diabetes, Chronic Kidney Disease
- Being tested
- Low Dietary Acid Load
- Keywords
- sex differences, Ethnic, acid lowering diet, Sweet & Sour, kidney health
- Medical subject headings
- Diabetes Mellitus, Type 2, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low Dietary Acid LoadOther
Also called Low Acid Load Diet
This arm will follow a DAL lowering diet with the aim to reach <25mEq H⁺/day
| Study group | Role | What they receive |
|---|---|---|
| High Dietary Acid Load | No intervention | This arm will follow their usual diet, which is between DAL> 50 or <120mEq H⁺/day (current western diets are generally all high DAL) |
| Low Dietary Acid Load | Experimental | This arm will follow a DAL lowering diet with the aim to reach <25mEq H⁺/day Receives: Other: Low Dietary Acid Load |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage change in urinary albumin-to-creatinine ratio (UACR)
Log-transformed urinary albumin-to-creatinine ratio (UACR), following an 8-week dietary intervention.
Measured: Change between baseline and 8 weeks
Secondary outcomes (7)
Change in estimated glomerular filtration rate (eGFR)
eGFR calculated using serum creatinine and/or cystatin C
Measured: Change between baseline and 8 weeks
Change in serum bicarbonate
Serum bicarbonate concentration measured in blood
Measured: Change between baseline and 8 weeks
Change in urinary citrate
Urinary citrate excretion measured in 24-hour urine collections
Measured: Change between baseline and 8 weeks
Glucose response during Oral Glucose Tolerance Test
Area under the curve (AUC) of plasma glucose during oral glucose tolerance test (OGTT)
Measured: Change between baseline and 8 weeks
Change in glucose variability (MAGE)
Mean amplitude of glycemic excursions (MAGE) derived from continuous glucose monitoring (CGM) data.
Measured: Change between baseline and 8 weeks
Change in gut microbiota composition
Gut microbiota composition assessed in morning fecal samples collected using stool collection kits analyzed by 16S rRNA gene sequencing.
Measured: Change between baseline and 8 weeks
Change in serum metabolite profiles
Serum metabolite profiles measured using untargeted metabolomics analysis.
Measured: Change between baseline and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2026
- Study start1 Jun 2026 (estimated)
- Primary completion1 Jun 2028 (estimated)
- Study completion1 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single-centre, non-blinded, randomized controlled 8-week isocaloric dietary intervention trial
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ilias Attaye, MD, PhD, Erasmus Medical Center
- Investigators
- Ilias Attaye, Dr., Principal investigator, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07587918
- Sponsor's protocol ID
- NL-010928
- Acronym
- Sweet & Sour
- Status last verified
- May 2026
- First submitted
- 22 Apr 2026
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Publication will be open access. All data is available upon resonable request from the Principal Investigator. Of note: All data will be pseudoanonymzed.
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sweet & Sour: Exploring Dietary Acid Load in Type 2 Diabetes & Kidney Disease Across Sex and Ethnicity
- ClinicalTrials.gov ID
- NCT07587918
- Acronym / sponsor ID
- Sweet & Sour / NL-010928
- Conditions
- Type 2 Diabetes, Chronic Kidney Disease
- Keywords
- sex differences, Ethnic, acid lowering diet, Sweet & Sour, kidney health
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 1 Jun 2028 (estimated)
- Study completion
- 1 Jun 2028 (estimated)
- First posted
- 14 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Single-centre, non-blinded, randomized controlled 8-week isocaloric dietary intervention trial
| Arm | Type | Receives |
|---|---|---|
| High Dietary Acid Load | No intervention | –This arm will follow their usual diet, which is between DAL> 50 or <120mEq H⁺/day (current western diets are generally all high DAL) |
| Low Dietary Acid Load | Experimental | Other: Low Dietary Acid LoadThis arm will follow a DAL lowering diet with the aim to reach <25mEq H⁺/day |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low Dietary Acid LoadAlso: Low Acid Load DietThis arm will follow a DAL lowering diet with the aim to reach <25mEq H⁺/day | Other | Low Dietary Acid Load |
Primary outcome
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.
7 secondary outcomes
Change in estimated glomerular filtration rate (eGFR)
Time frame: Change between baseline and 8 weeks
Change in serum bicarbonate
Time frame: Change between baseline and 8 weeks
Change in urinary citrate
Time frame: Change between baseline and 8 weeks
Glucose response during Oral Glucose Tolerance Test
Time frame: Change between baseline and 8 weeks
Change in glucose variability (MAGE)
Time frame: Change between baseline and 8 weeks
Change in gut microbiota composition
Time frame: Change between baseline and 8 weeks
Change in serum metabolite profiles
Time frame: Change between baseline and 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
- Individual participant dataSharing planned: Yes. Publication will be open access. All data is available upon resonable request from the Principal Investigator. Of note: All data will be pseudoanonymzed.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ilias Attaye, Dr. principal investigator
Erasmus Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low Dietary Acid Load in people with Type 2 Diabetes and Chronic Kidney Disease, run by Erasmus Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ilias Attaye, Dr. (+31 10 704 0704, i.attaye@erasmusmc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage change in urinary albumin-to-creatinine ratio (UACR) (time frame: Change between baseline and 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2026.