A Trial Comparing a Diet Including Products Aimed at Targeting Satiety
A Trial Comparing a Diet Including Products Aimed at Targeting Satiety
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.
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)
Inclusion Criteria:

 -  BMI ≥ 27,0 and ≤ 35,0 kg/m2

 -  Fat mass ≥ 23 % as assessed by bio impedance at the screening visit

 -  Healthy

 -  Acceptance of the experimental foods

 -  Provided voluntary written informed consent

 Exclusion Criteria:

 -  < 8.0% weight loss during the Low Calorie Diet (LCD) period (will be assessed at visit
 7 after having completed the 8 week LCD period)

 -  Dislike ≥ 25% of the study products (will be assessed at visit 7 through test tasting)

 -  Known diseases which may affect energy expenditure and/or satiation/satiety/food
 intake i.e. inflammatory bowel disease, thyroid deceases, major depressions and
 bipolar deceases

 -  Eating behaviour characteristics (e.g. restrained eating, disinhibition, emotional
 eating) identified at the screening visit based on questionnaires

 -  Weight changes ±3 kg in the last three months

 -  Dietary patterns interfering with the study protocol, as judged by the Investigator
 (e.g. vegetarian, vegan, low carb dieters, high fat dieters) two months prior
 inclusion, during the study or plans to initiate during the study

 -  Severe food allergies and food intolerances expected to interfere with the study

 -  Engagement in elite sports or similar strenuous exercise ≥ 5h/week

 -  Pregnancy or lactation, pregnancy within the past 12 month or plans to become pregnant
 during the study

 -  Smoking, smoking cessation within the past three months and/or nicotine use (including
 electronic cigarettes)

 -  Medical conditions as known by the participants:

 -  Diabetes mellitus (type 1 and 2) (History of gestational diabetes mellitus is
 allowed)

 -  Cardiovascular disease including current angina; myocardial infarction; coronary
 revascularization procedures; stroke (either ischemic or hemorrhagic, including
 transient ischemic attacks); symptomatic peripheral artery disease that required
 surgery or was diagnosed with vascular imaging techniques; ventricular
 arrhythmia; uncontrolled atrial fibrillation; congestive heart failure (New York
 Heart Association Class II or IV); hypertrophic myocardiopathy; and history of
 aortic aneurism ≥5.5 cm in diameter or aortic aneurism surgery within the past
 six months, as diagnosed by a medical doctor

 -  Systolic blood pressure above 160 mmHg and/or diastolic blood pressure above 100
 mmHg whether on or off treatment for hypertension. If being treated, stable
 treatment (i.e. no change in treatment, either dose, type of medication or other
 changes) within last 3 months is required

 -  Chronic kidney disease defined as either kidney damage or estimated Glomerular
 Filtration Rate (eGFR) of less than 60 mL/min/1.73m2 or Creatinine >1.5 times
 upper limit of normal (according to local laboratory reference values) for longer
 than 3 months as diagnosed by a medical doctor

 -  Liver disease e.g. cirrhosis (fatty liver disease allowed), or liver dysfunction
 with transaminases (Alanine Transaminase (ALT) and/or Aspartate Transaminase
 (ASAT)) more than 3 times the upper limit of normal (according to local
 laboratory reference values) as diagnosed by a medical doctor

 -  Active inflammatory bowel disease, celiac disease, chronic pancreatitis or other
 disorder potentially causing malabsorption

 -  Cancer - active malignant cancer or history of malignancy within the last 5 years
 (with exception of local basal and squamous cell skin cancer).

 -  Previous bariatric surgery or intention to undergo bariatric surgery within the
 next 12 months

 -  History of extensive small or large bowel resection

 -  Known endocrine origin of obesity (except for treated hypothyroidism)

 -  Transmissible blood-borne diseases e.g. hepatitis B, HIV

 -  Any recent surgical procedure not fully recovered (as judged by the investigator)

 -  Current use of prescription medication or use within the previous month that has the
 potential of affecting body weight such as systemic corticosteroids (excluding inhaled
 and topical steroids) psychoactive medication, epileptic medication, or weight loss
 medications (either prescription, over the counter or herbal). Low dose
 antidepressants are allowed if they, in the judgment of the investigator, do not
 affect body weight or participation in the study protocol. Levothyroxine for treatment
 of hypothyroidism is allowed if the participant has been on a stable dose for at least
 3 months

 -  Current use of prescription medication that does not affect body weight should have
 been stable for the past 3 months and expected to be stable during the study

 -  Concurrent therapy with immunosuppressive drugs or cytotoxic agents

 -  Haemoglobin concentration below local laboratory reference values (i.e. anaemia)

 -  Blood donation or transfusion within the past month before screening or during the
 study

 -  Regularly consumption of alcohol above recommendations; > 21 alcoholic units/week
 (men), or > 14 alcoholic units/week (women)

 -  Drug abuse, as judged by the investigator, within the previous 12 months

 -  Psychological or behavioural problems which, in the judgement of the investigator,
 would lead to difficulty in complying with the study protocol

 -  Psychiatric disorders: schizophrenia, bipolar disease, eating disorders, or depression
 with hospitalization within the last 6 months.

 -  Participation in other clinical trials within the past three months or intention to do
 so during the study, which are likely to affect the present study

 -  History of repeated failure to complete a LCD

 -  Allergy or intolerance for components of the LCD product

 -  Unable to follow the recommended diet for religious reasons, swallowing disorders,
 other physiological reasons or any other reasons for not being able to follow the
 recommended diet

 -  Inability or unwillingness to give written informed consent or communicate with study
 personnel

 -  Inability or unwillingness to follow the study protocol and instructions giving by the
 study personnel

 -  Institutionalization - permanent or long-stay resident in a care home or similar
 institution

 -  Illiteracy

 -  Any other condition that judged by the investigator may interfere with the adherence
 to the study protocol