diabetes obesity overweight Type 2 diabetes mellitus
Conditions
Interventions
All participants, (with the exception of the fMRI-substudy control group,)
independent of randomization will receive dietary advice based on existing
recommendations for a healthy diet, importantly
Sponsors
University of Copenhagen
Eligibility
Age
2 Years to 99 Years
Inclusion criteria
Inclusion criteria: Adults: - Age: 18-65 years. - BMI: *25.0 kg/m2 (no upper limit). - For women: Use of contraceptive methods and not wishing/planning to become pregnant the 2 years of the intervention study. - Regular consumption of sugar-containing/sugar-sweetened products. - Motivation and willingness to be randomized to any of the two groups and to do the best to follow the given protocol. Children: - Age: 6 up to and including 12 years. - BMI-for-age: >85th percentile (no upper limit). - Able to participate in CID*s and the dietitian-investigator meeting (month 18) during normal working hours. - Motivation and willingness to be randomized to any of the two groups and to do the best to follow the given protocol. fMRI sub-study: control group - Age: 18 up to and including 65 years. - BMI: *25.0 kg/m2 (no upper limit). - For women: Use of contraceptive methods and not wishing/planning to become pregnant the 2 years of the intervention study. - Regular consumption of sugar-containing/sugar-sweetened products.
Exclusion criteria
Exclusion criteria: Adults: Based on interview and/or questions, adults with the following issues will be excluded: - Weight change (increase or decrease) >5% during the past 2 months prior to the study. - Surgical treatment of obesity. - Blood donation 21 alcoholic units/week (men), or > 14 alcoholic units/week (women). - Intensive physical training (>10 hours of per week). - Self-reported eating disorders. - Intolerance and allergies expected to interfere with the study. - Self-reported use of drugs of abuse within previous 12 months. - Night- or shift work. - For women: Pregnancy, lactation. - Persons who do not have access to either (mobile) phone or internet - Insufficient communication with national language. - Regular use of pro-/prebiotics - Inability, physically or mentally, to comply with the procedures required by the study protocol as evaluated by the daily study manager, site-PI, PI or clinical responsible. - Subject*s general condition contraindicates continuing the as evaluated by the daily study manager, site-PI, PI or clinical responsible. - Simultaneous participation in other clinical intervention studies. Medical conditions as known by the persons: - Diagnosed diabetes mellitus. - Medical history of CVD - Systolic BP above 160 mmHg and/or diastolic BP above 100 mmHg (measured at screening) whether on or off treatment for hypertension. - Significant liver disease, e.g. cirrhosis (fatty liver disease allowed). - Malignancy which is currently active or in remission for less than five years after last treatment (local basal and squamous cell skin cancer allowed). - Active inflammatory bowel disease, celiac disease, chronic pancreatitis or other disorder potentially causing malabsorption. - Thyroid diseases, except those on Levothyroxine treatment of hypothyroidism if the person has been on a stable dose for at least 3 months. - Psychiatric illness (e.g. major depression, bipolar disorders). Medication: - Use currently or within the previous 3 months of prescription or over the counter medication that has the potential of affecting body weight incl. food supplements. - Use of antibiotics during the 3 months prior to the start of the study - Cholesterol or BP lowering medication, if the dose has changed during the last 3 months Laboratory screening: If all of the above criteria are satisfied, the adult participant is eligible for a laboratory screening. A blood sample is collected and immediately analyzed for the following exclusion criteria: - Prevalence of type 2 diabetes (Fasting Glucose * 7.0 mmol/L) - Low haemoglobin levels (to predict anemia etc.) - Kidney malfunction (Creatinine) - Liver malfunction (ALT, AST, Gamma-GT) Children: Based on interview and/or questions with the child and the representative adult, children with the following issues will be excluded: - Intensive physical training (>10 hours of per week). - Self-reported eating disorders. - Intolerance and allergies expected to interfere with the study. - Insufficient communication with national
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The two co-primary endpoints are change in the body weight (i.e. efficacy) and change in gut microbiota (i.e. safety) both measured in adults from baseline to year 1. | — |
Secondary
| Measure | Time frame |
|---|---|
| Other secondary endpoints are changes in; anthropometry, risk factors for cardiovascular disease (blood pressure, lipidemia) and type 2 diabetes (glycemia), adverse events (AE), concomitant medication, appetite sensation, and allergenicity. | — |
Countries
Netherlands
Outcome results
None listed