- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03866343
Restriction of Dietary AGEs to Prevent Diabetes in Overweight Individuals
Restriction of Dietary AGEs to Prevent Diabetes in Overweight Individuals: a Randomized Controlled Trial
Current efforts to arrest the epidemic of type 2 diabetes mellitus (T2DM) have had limited success. Thus there is an urgent need for effective approaches to prevent the development of T2DM. It is widely accepted that the current epidemic is driven by an increase in global food abundance and reduced food quality, making changes in diet a key determinant of the T2DM epidemic. Dietary factors can affect cardio-metabolic health; among these factors, advanced glycation end-products (AGEs) in food are potential risk factors for insulin resistance and T2DM.
AGEs are a heterogeneous group of unavoidable stable bioactive compounds. Endogenous formation of AGEs is a continuous naturally occurring process, and is the result of normal metabolism. However, increased formation of AGEs occurs during ageing and under hyperglycaemic conditions. AGEs are implicated in the development of diabetes and vascular complications.
Over the past several decades, methods of food processing have changed and meals now contain excess fat and sugar and are most susceptible for the formation of AGEs. In addition, AGEs in food are highly desirable due to their profound effect on shelf life, sterility, flavour, colour, and thus food consumption. Hence, a substantial portion of AGEs are derived from exogenous sources, particularly food. These exogenous AGEs are potential risk factors for insulin resistance and the development of T2DM. The investigators recently found that dietary AGEs represent a significant source of circulating AGEs, and have similar pathogenic properties compared to their endogenous counterparts including the development of insulin resistance and T2DM. Taken together, dietary AGEs are proposed to play a pivotal role in the development and progression of T2DM and its complications. Reduction of dietary intake of AGEs may therefore be an alternative strategy to reduce the risk of vascular disease and insulin resistance. The investigators therefore hypothesize that dietary restriction of AGEs in overweight individuals improves insulin sensitivity, β-cell function, and vascular function.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Limburg
-
Maastricht, Limburg, Netherlands, 6226
- Maastricht University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Abdominal obesity: waist circumference for men ≥ 102 cm, and for women ≥ 88 cm.
- Aged 18 years and older
- Caucasian (because of skin fluorescence and capillary microscopy measurements)
Exclusion Criteria:
- Diabetes (i.e. using anti-diabetic medication, fasting glucose >7.0 mmol/L, HbA1c >6.5%).
- Active or history of cardiovascular disease (e.g. stroke, coronary artery disease, peripheral vascular disease, congestive heart failure, cardiac shunts, cardiac surgery, pulmonary hypertension, cardiac arrhythmias, family history of cardiac arrhythmias or sudden cardiac death)
- Hyperlipidemia (defined as serum total cholesterol > 8 mmol/L or TG > 4 mmol/L)
- Lipid lowering medication (e.g. statins)
- Use of medication known to influence glucose metabolism, vascular function and/or lipid metabolism (e.g. statins, glucocorticosteroids, NSAID's)
- Inability to stop antihypertensive medication for 13 weeks. Exclusion of higher grade hypertension (> 179 mmHg SBP and/or > 109 mmHg DBP) in order not to expose subjects to unnecessary risks)
- Pulmonary or inflammatory disease
- Kidney failure or electrolyte disorders
- Pregnancy or lactation
- No change in use of oral anticonceptiva or IUD (12 weeks prior of during the intervention)
- Known allergic reaction to ultrasound contrast-agent
- Smoking (active or cessation <1 year prior to screening date).
- High alcohol usage (>4 U/day) or drug abuse
- Use of dietary supplements or an investigation product within the previous month
- Significant food allergies/intolerance
- Vegetarianism
- Subjects who intend to donate blood during the intervention or subjects who have donated blood less than three months before the start of the intervention.
- Participation in another biomedical trial during the past 30 days.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Low AGE diet
Subjects will be asked to consume a diet containing a low AGE content for 4 weeks.
|
All subjects will undergo an intervention consisting of a prescribed diet containing either a low or high quantity of AGEs during 4 continuous weeks.
|
OTHER: High AGE diet
Subjects will be asked to consume a diet containing a high AGE content for 4 weeks.
|
All subjects will undergo an intervention consisting of a prescribed diet containing either a low or high quantity of AGEs during 4 continuous weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Insulin sensitivity
Time Frame: Difference after 4 weeks of intervention
|
Assessed by hyperinsulinaemic-euglycaemic clamp
|
Difference after 4 weeks of intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Microvascular function
Time Frame: Difference after 4 weeks of intervention
|
Assessed by contrast-enhanced ultrasound (CEUS) in skeletal muscle
|
Difference after 4 weeks of intervention
|
Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
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
Other Study ID Numbers
- NL63215.068.17
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.
Clinical Trials on Diet
-
University of ReadingActive, not recruitingDiet Modification | Diet, Healthy | Diet HabitUnited Kingdom
-
University of Rhode IslandCompletedDiet Modification | Diet HabitUnited States
-
National Cancer Institute (NCI)CompletedDiet | Diet SurveysUnited States
-
University of LeedsBritish Medical Research CouncilCompletedDiet Surveys | Diet RecordsUnited Kingdom
-
Universidade do PortoCentro Hospitalar Universitário de São João, E.P.E.; Centro de Investigação... and other collaboratorsRecruitingNutritional Status | Diet, Vegetarian | Diet, Vegan | Metabolic ProfilePortugal
-
Washington State UniversityUnited States Department of Agriculture (USDA)Not yet recruitingHealth Behavior | Diet, Healthy | Diet HabitUnited States
-
Luis María Béjar PradoRecruitingHealthy Eating Index | Mediterranean Diet | Diet HabitsSpain
-
University of ReadingRoyal Berkshire NHS Foundation TrustActive, not recruitingDiet Modification | Diet Habit | Cardiac EventUnited Kingdom
-
University of California, San FranciscoCompleted
-
University of HawaiiPennington Biomedical Research Center; United States Department of Agriculture...RecruitingDiet, HealthyUnited States
Clinical Trials on Diet low or high in advanced glycation endproducts
-
University Hospitals of Derby and Burton NHS Foundation...British Renal Society; Kidney Care UKCompleted
-
University of CopenhagenEuropean CommissionCompletedObesity | Cardiovascular Disease | Metabolic Syndrome | Type 2 DiabetesDenmark
-
University of California, San Franciscooptimal wellness labsWithdrawn
-
Sahlgrenska University Hospital, SwedenCompletedIrritable Bowel SyndromeSweden
-
Mondelēz International, Inc.Centre de Recherche en Nutrition Humaine Rhone-Alpe; Biofortis Mérieux NutriSciencesCompleted
-
Federico II UniversityCompletedType 2 Diabetes | Postprandial Lipids Metabolism
-
Mondelēz International, Inc.Centre de Recherche en Nutrition Humaine Rhone-Alpe; Biofortis Mérieux NutriSciencesRecruiting
-
Washington University School of MedicineCompleted
-
Wageningen UniversityUnilever R&D; Netherlands Heart FoundationCompletedHypertension | Overweight | Insulin Resistance | Dyslipidemia | Metabolic Syndrome XNetherlands
-
Odense University HospitalNovo Nordisk A/S; University of Southern Denmark; Region of Southern Denmark; Odense... and other collaboratorsCompletedAtherosclerosis | Dyslipidemias | Type2 Diabetes | Nonalcoholic Steatohepatitis | Non-Alcoholic Fatty Liver DiseaseDenmark