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. 2022 Oct 12;12(10):e061075. doi: 10.1136/bmjopen-2022-061075

Table 1.

List of exclusion criteria

Adults Children
General
Weight change >5% 2 months prior to screening
Surgical treatment of obesity
Blood donation <3 months prior to study initiation
Change in smoking habits during the last month. (Smoking was allowed and monitored throughout the study)
Regularly drinking >21 (men) or >14 (women) units of alcohol per week
Intensive physical training (>10 hours per week)
Self-reported eating disorders
Intolerance and allergies expected to interfere with the study
Self-reported drug abuse within the previous 12 months
Night- or shift work that ends later than 23:00
For women: pregnancy, lactation
Persons who do not have access to either (mobile) phone or Internet
Insufficient communication with national language
Inability, physically or mental, to comply with the procedures required by the study protocol
Participant’s general condition contraindicates continuing the study
Simultaneous participation in other clinical intervention studies
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 language
Inability, physically or mental, to comply with the procedures required by the study protocol
Participant’s general condition contraindicates continuing the study
Simultaneous participation in other clinical intervention studies
Medical conditions
Diagnosed diabetes mellitus
Medical history of CVD (eg, current angina; myocardial infarction or stroke within the past 6 months; heart failure; symptomatic peripheral vascular disease)
Systolic blood pressure above 160 mmHg and/or diastolic blood pressure above 100 mmHg (measured at screening) whether on or off treatment for hypertension
Significant liver diseases for example, cirrhosis (fatty liver disease allowed)
Malignancy which was active or in remission for less than 5 years after last treatment (local basal and squamous cell skin cancer allowed)
Active inflammatory bowel disease, coeliac disease, chronic pancreatitis or other disorder potentially causing malabsorption
Thyroid diseases, except Levothyroxine treatment of hypothyroidism if not on a stable dose for at least 3 months
Psychiatric illness (eg, major depression, bipolar disorders)
Diagnosed diabetes mellitus
Other diseases that may influence the study outcomes
Medication
Use currently or within the previous 3 months of prescription or over the counter medication that had the potential of affecting body weight including food supplements
Exceptions related to medical conditions:
I) Cholesterol or blood pressure lowering medication was allowed if the participant’s dose had not changed during the last 3 months
II) Low dose antidepressants if they, in the judgement of the investigator, did not affect weight or study participation.
III) Levothyroxine for treatment of hypothyroidism if on a stable dose for at least 3 months
Use currently or within the previous 3 months of prescription or over the counter medication that had the potential of affecting body weight including food supplements
Laboratory screening*
Glucose >7.0 mmol/L
Haemoglobin:
women; <7.5 mmol/L (Copenhagen, Maastricht, Navarra, Athens)
men; <8.5 mmol/L (Copenhagen, Maastricht) and<8.1 mmol/L (Navarra, Athens)
For Maastricht participants only:
Creatinine <50 µmol/L and >100 µmol/L
ALT >34 IU

*Fasting blood sample was collected from adults and locally analysed to assess glucose and haemoglobin levels, and some additional values at Maastricht.

ALT, Alanine transaminase; CVD, cardiovascular diseases; IU, international unit.