Sweeteners and Sweetness Enhancers: Prolonged Effects on Health, Obesity and Safety
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      The aim of this randomised controlled trial (RCT) is to investigate if prolonged consumption
      of sweetener and sweetness enhancers (S&SEs) within a healthy diet approach will improve
      weight loss maintenance and obesity related risk factors, and affect safety markers, compared
      to sugar.

      We hypothesize, that:

        -  Prolonged use of S&SEs in beverages and food matrices will result in improved body
           weight control because S&SEs will increase palatability of the diet and thereby increase
           compliance to the recommendations for a healthy diet.

        -  There will be no safety concerns using S&SEs in the long term.

      Overweight/obese adults and families where at least one adult (both gender) and one child
      (both gender) are overweight/obese will be recruited. The majority of measurements will only
      be conducted in the adult population and some measurement will only be done in sub-groups.
      The intervention will be performed in four countries: Denmark, Greece, Spain and the
      Netherlands.

      The goal is approximately 370 participants - 330 adults (18-65 years of age) and 40 children
      (6-12 years of age) - will be recruited for the study. All adult participants are first
      treated by a low energy diet (LED) for 2 months with the aim to reduce body weight (minimum
      5% weight loss (WL)), whereas children are treated separately with a conventional weight
      maintenance (WM) diet, without a specific aim for absolute WL.

      The participants - both adults and families - are randomized into two different diet
      interventions for 10 months with or without inclusion of S&SEs products (foods and drinks).
      For adults, this period aims at preventing weight re-gain and for children maintaining body
      mass index (BMI)-for-age. The participants will receive food exchange lists and will be
      guided by dieticians. The randomization will be stratified by age, sex and BMI. Adults (not
      participating with children) belonging to the same household and all members of a family will
      be assigned the same intervention - the randomization will here solely be based on the oldest
      adult in the family/household.

      The adult participants are weighed at months 0, 0.5 and 1, and if needed at month 1.5. They
      are supervised during the WL period at months 0 and 1, and if needed at months 0.5 and 1.5,
      and throughout the WM period at months 2, 4, 6, 9 and 12. Children will follow a similar, but
      less strict time schedule (their participation is preferred but not required for all
      dietician meetings).

      The main assessment points are the clinical investigation days (CIDs) at month 0 (baseline,
      start of the WL period), 2 (end of the WL period/start of randomized intervention), 6 (6
      months from baseline) and 12 (1 year from baseline).
    


Intervention name(s): S&SEs; Sugar
Intervention type(s): Behavioral; Behavioral
Intervention description(s): S&SEs:
As many sugar-containing products in the diet as possible should be replaced with S&SE-containing products.
To ensure that a certain amount of S&SE products is consumed every day, a fixed minimum amount of units for each individual is planned.; Sugar group:
In the sugar group it is allowed to consume up to a certain number of units of sugar-containing products each day, corresponding to < 10 E% added sugar.
The sugar group is not allowed to consume any S&SE products.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention