Sweeteners and sweetness enhancers: Prolonged effects on health, obesity and safety

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 108

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

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 < 3 month prior to study.
- Change in smoking habits during the last month. Smoking is allowed provided
subjects have not recently changed habits. However, smoking status is monitored
throughout the study and used as a confounding variable.
- Regularly drinking > 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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The two co-primary endpoints are change in the body weight (i.e. efficacy) and<br /><br>change in gut microbiota (i.e. safety) both measured in adults from baseline to<br /><br>year 1. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Other secondary endpoints are changes in; anthropometry, risk factors for<br /><br>cardiovascular disease (blood pressure, lipidemia) and type 2 diabetes<br /><br>(glycemia), adverse events (AE), concomitant medication, appetite sensation,<br /><br>and allergenicity.</p><br>