SATIN Satiety Diet - Proof of Concept V7
Research type
Research Study
Full title
A randomized, double-blind trial comparing a diet including satiating products to control products
IRAS ID
184670
Contact name
J.C.G Halford
Contact email
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 9 months, 9 days
Research summary
Overweight and obesity provide a major challenge to European health. The diet of many Europeans can currently be characterised by high levels of fat and sugars. The availability of a range of healthy foods that satisfy the appetite may help consumers in establishing and maintaining a balanced diet. This multi-centre, double blinded randomised controlled trial will evaluate the impact of a healthy diet supplemented with a satiety-enhancing product on weight control after an initial period of weight loss. Participants will be 300 adults (BMI >28kg/m2 <35kg/m2; Age between 20 and 65 years) who will attend assessments at one of three sites (University of Liverpool, United Kingdom; University of Copenhagen, Denmark and University Rovira I Virgili, Spain). 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 study. Participants reaching the pre-defined weight loss will enter the 12-week randomised part of the study. They will be advised to follow a general healthy weight loss maintenance diet. In addition, participants will be randomly allocated to consume daily either 1) an active satiety-enhancing product or 2) similar control product without satiety-enhancing properties. For each participant, the total study duration is 24 weeks, and includes 17 visits at the study site in total. Primary study visits will occur at the beginning, after 8 weeks and at the end of the intervention period. Primary outcome will be energy intake and changes in appetite as well as weight maintenance after low calorie diet (as assessed by weight, waist circumference and body composition (DXA)). Secondary outcomes include biomarkers of health outcomes (blood and urine indices) and consumer benefits of the trial (questionnaires and cognitive tasks) to determine diet efficacy.
REC name
North West - Preston Research Ethics Committee
REC reference
16/NW/0135
Date of REC Opinion
29 Mar 2016
REC opinion
Further Information Favourable Opinion