Erasmus Medical Center
Rotterdam, Netherlands
Location contact
Dagmar Dekker, MSc
SUB_INVESTIGATOR
Ilias Attaye, Dr.
CONTACT
Ilias Attaye, Dr.
PRINCIPAL_INVESTIGATOR
NCT Number: NCT07587918
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Not applicable
Rotterdam, Netherlands
Dagmar Dekker, MSc
SUB_INVESTIGATOR
Ilias Attaye, Dr.
CONTACT
Ilias Attaye, Dr.
PRINCIPAL_INVESTIGATOR
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
This arm will follow a DAL lowering diet with the aim to reach <25mEq H⁺/day
Other names: Low Acid Load Diet
Time frame: Change between baseline and 8 weeks
Log-transformed urinary albumin-to-creatinine ratio (UACR), following an 8-week dietary intervention.
Time frame: Change between baseline and 8 weeks
eGFR calculated using serum creatinine and/or cystatin C
Time frame: Change between baseline and 8 weeks
Serum bicarbonate concentration measured in blood
Time frame: Change between baseline and 8 weeks
Urinary citrate excretion measured in 24-hour urine collections
Time frame: Change between baseline and 8 weeks
Area under the curve (AUC) of plasma glucose during oral glucose tolerance test (OGTT)
Time frame: Change between baseline and 8 weeks
Mean amplitude of glycemic excursions (MAGE) derived from continuous glucose monitoring (CGM) data.
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.
Time frame: Change between baseline and 8 weeks
Serum metabolite profiles measured using untargeted metabolomics analysis.
Contact information is provided by the study sponsor or research team.
Erasmus Medical Center
Other
Sweet & Sour: Exploring Dietary Acid Load in Type 2 Diabetes & Kidney Disease Across Sex and Ethnicity
Acronym: Sweet & Sour
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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