A Randomized, Double-blind Multi-centre Trial Comparing a Diet Including Satiating Products Compared to Control Products - SATIN Satiety Diet - Proof of Concept
Abstract
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…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 298 participants or records.
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