Diabetes, Impaired glucose tolerance
Conditions
Interventions
During Phase 1, participants will be provided with three intervention meals.
They will consume one study meal each week at the clinic in the morning. The
three different intervention meals are isoca
Sponsors
Wageningen Universiteit
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Men and women Age 40 to 70 years Body mass index (BMI) 27-35 kg/m2, or 25-27 kg/m2 with abdominal obesity (waist circumference >88cm (women) or >102cm (men) Signed informed consent
Exclusion criteria
Exclusion criteria: - Medical history of diagnosed cardiovascular disease (e.g. stroke, heart disease) - Diagnosed type 1 or type 2 diabetes - Antibiotic use in the last 3 months - Taking Diabetes drugs; medication like statins, medication to manage hypertension are not grounds for exclusion, if the medication regimen has been stable for the last three months - (Unwilling to stop) dietary supplement use (other than vitamins/minerals/amino acids/fish oils) that may interfere with study outcomes - Stomach and gastrointestinal conditions (e.g. Morbus Chron, Ulcerative colitis, irritable bowel syndrome, malabsorption, colostomy, bowel resection, gastric bypass surgery etc.) - History of major gastrointestinal surgery - Chronic or acute inflammatory conditions (e.g., rheumatoid arthritis, psoriatic arthritis) - Thyroid disorders - Significant renal or liver dysfunction or chronic kidney or liver disease - Known food allergies/intolerances to intervention foods or food products used in the study - Following specific dietary regimen that could impact results - Current or planned pregnancy or lactating - Other serious medical conditions that could interfere with participation - Unable to sufficiently understand written and spoken national language (where the study center is located) to provide written consent and understand information and instructions from the study personnel.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome parameters are the differences in postprandial glucose, triglyceride, and IL-6 response to a high-fat mixed-meal (HFMM) test following 6 weeks of intervention with personalised dietary advice compared to 6 weeks of a control dietary advice. | — |
Secondary
| Measure | Time frame |
|---|---|
| Our secondary outcomes in Phase 1 include differences in 1) metabolic factors, 2) gut microbiota 2) immune health, 3) microbiota and gut health, 4) underlying biological mechanisms and 5) wellbeing between meals. The specific outcomes related to these objectives are shown in Table 1. We further aim to explore determinants of response/no response to meals in metabolic factors using microbiota, epigenomics, transcriptomics and metabolomics data, as well as differences in appetite between meals. Our secondary outcomes in Phase 2 include differences in metabolome, epigenome, transcriptome, and gut microbiota between personalised diet vs general healthy diet. We will also consider differences in metabolic health score between personalised diet vs general healthy diet and evaluate the predicted response/non-response to personalised vs general diet in Phase 2 based on metabolomics, gut microbiome, epigenomics, transcriptomics, health, metabolic and dietary data at baseline. In addition, workflows will be built on data from both phases in which multi-layered nutrition data will be assessed, combined and analysed to dissect the underlying mechanisms behind response/non-response to diet. Furthermore, differences in putative food intake biomarkers to validate compliance to personalised diets in Phase 2 will be conducted. This includes also effects of the intervention on epigenome- and transcriptome-wide effects in PBMCs isolated from fasting samples. 1) Metabolic health Differences in response following the Phase 1 test meals on: a. Blood glucose; b. Blood lipid spectrum; c. Levels of inflammation markers; d. Blood glucose, lipid and inflammation markers as measured at-home; e. Circulating metabolites before and after a HFMM under fasting and postprandial conditions; Differences in response following Phase 2 HFMM tests on: a. Blood glucose, lipid and inflammation markers as measured at-home; b. Circulating metabolites before and after a HFMM unde | — |
Countries
Netherlands, Norway, Sweden
Contacts
Public ContactTMG Dronkers
Wageningen Universiteit
Outcome results
None listed