- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07587918
Sweet & Sour: Dietary Acid Load in Type 2 Diabetes and Kidney Disease Across Sex and Ethnic Groups (Sweet & Sour)
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Ilias Attaye, Dr.
- Phone Number: +31 10 704 0704
- Email: i.attaye@erasmusmc.nl
Study Locations
-
-
-
Rotterdam, Netherlands
- Erasmus Medical Center
-
Contact:
- Ilias Attaye, Dr.
- Phone Number: +31 10 704 0704
- Email: i.attaye@erasmusmc.nl
-
Principal Investigator:
- Ilias Attaye, Dr.
-
Sub-Investigator:
- Dagmar Dekker, MSc
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: 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)
|
|
|
Experimental: 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
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Change between baseline and 8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in estimated glomerular filtration rate (eGFR)
Time Frame: 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
Time Frame: Change between baseline and 8 weeks
|
Serum bicarbonate concentration measured in blood
|
Change between baseline and 8 weeks
|
|
Change in urinary citrate
Time Frame: 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
Time Frame: 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)
Time Frame: 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
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.
|
Change between baseline and 8 weeks
|
|
Change in serum metabolite profiles
Time Frame: Change between baseline and 8 weeks
|
Serum metabolite profiles measured using untargeted metabolomics analysis.
|
Change between baseline and 8 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ilias Attaye, Dr., Erasmus Medical Center
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Urogenital Diseases
- Endocrine System Diseases
- Pathologic Processes
- Male Urogenital Diseases
- Kidney Diseases
- Urologic Diseases
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Chronic Disease
- Disease Attributes
- Metabolic Diseases
- Glucose Metabolism Disorders
- Diabetes Mellitus
- Renal Insufficiency
- Pathological Conditions, Signs and Symptoms
- Nutritional and Metabolic Diseases
- Diabetes Mellitus, Type 2
- Renal Insufficiency, Chronic
Other Study ID Numbers
- NL-010928
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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