A Trial Comparing a Diet Including Products Aimed at Targeting Satiety
Condition: Weight; Appetite
Study type: Interventional

Summary: 
      This multi-centre, randomised controlled trial will be conducted over 12-weeks to evaluate
      whether lower appetite is associated with weight loss maintenance success. The effect of a
      healthy diet supplemented with products that could enhance feelings of satiety and reduce
      food intake after an initial weight loss period to assess weight maintenance. Participants
      will either receive the active SATIN product or a matched control product. The products
      contain ingredients which have been shown to positively affect satiety, satiation and/or body
      weight and are all accepted food ingredients approved for human consumption in Europe. They
      will be incorporated into different food matrices, e.g. drinks, shakes and cheeses.
      Corresponding control products without the active ingredients will be provided to
      participants allocated to the control group. The participants will be instructed in detail on
      how and when to consume the test products. Participants will be 300 adults (BMI >27kg/m2;
      Age>18years) who will be tested at three research sites (University of Liverpool, United
      Kingdom; University of Copenhagen, Denmark and University Rovira I Virgili, Spain).
      Recruitment will be divided between sites. Participants will attend assessments at one of the
      three research sites continually throughout the study period. The primary outcome is to
      assess potential associations between changes in appetite (ad libitum energy intake, acute as
      well as sustained) and change in body weight during the 12-week follow-up period. Secondary
      outcomes include assessing waist circumference, body composition (DXA), subjective appetite,
      biomarkers of health outcomes (blood and urine indices), changes in physical activity as well
      as consumer benefits of the trial (assessed in a range of questionnaires) to determine diet
      efficacy.
    

Detailed description: 
      The study is a double blinded parallel randomized multicentre study, with six arms. The study
      will be conducted simultaneously in Denmark, Spain and United Kingdom, at the study sites
      specified on page 3. A total of 300 participants with an initial BMI of 27 to 35 kg/m2 and a
      fat mass of no less than 23% will be enrolled in the study. An initial weight loss of a
      minimum of 8 % will be needed for inclusion in the randomized part of the study. The weight
      loss will be achieved by administration of a low calorie diet (LCD) for 8 weeks managed by
      dietician supervised group sessions. Failure to reach at least 8% weight reduction during the
      LCD will result in exclusion from the intervention.

      Participants reaching the pre-defined weight loss of no less than 8% will enter a 7-10 days
      run-in period for diet stabilization before entering the 12-week randomized part of the
      study. In the randomized part of the study all participants will be advised to follow a
      general healthy weight loss maintenance diet in accordance with national dietary guidelines.
      In addition, participants will be randomly allocated in a 1:1 ratio to one of the following
      intervention groups; 1) including an active satiety enhancing product (active intervention
      group) or 2) including a similar control product without satiety enhancing properties
      (control group).

      For both groups, the participants will be instructed to consume the intervention products
      daily. Primary study visits for the assessment of body weight, waist circumference, hip
      circumference, sagittal diameter and blood pressure will be performed at the beginning, and
      at the end of the intervention period. At least every four weeks during the intervention, the
      participants will be requested to pick up the study products, and during these visits
      bodyweight and waist and hip circumference will be recorded. The participants will
      furthermore meet individually with a dietician three times during the 12 weeks intervention
      period to enhance compliance with the weight loss maintenance diet and to ensure
      incorporation of the study specific products into their diet as instructed. Adverse events
      and concomitant medicine will be registered continuously throughout the study. For each
      participant, the total study duration is 24 weeks, and includes 17 visits at the study site
      in total (14+3 appetite probe days)
    

Intervention name(s): Active Diet Products; Placebo Diet Products
Intervention type(s): Other; Other
Intervention description(s): A range of Active Diet Products that will be provided as part of a weight maintenance diet which contain active ingredients aimed at increasing satiety (such as inulin, β-glucan, protein, and mycoprotein). All ingredients are accepted food ingredients approved for human consumption in Europe.; A range of Placebo Diet Products matching those provided in the Active Diet which will be provided as part of a weight maintenance diet but do not contain additional ingredients aimed at improving satiety (food matrices will be the same - e.g. shakes, cheeses etc but without active ingredients).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: satiation; satiety; weight loss; maintained weight loss