A Trial Comparing a Diet Including Products Aimed at Targ... | NCT02485743

Name	Class
University of Copenhagen	OTHER
University Rovira i Virgili	OTHER

Description Module

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)

Label	Type	Description	Intervention Names
Active Diet Products	Active Comparator	A range of 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.	Other: Active Diet Products
Placebo Diet Products	Placebo Comparator	A range of 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).	Other: Placebo Diet Products

Name	Type	Description	Arm Group Labels	Other Names
Active Diet Products	Other	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in appetite related to change in maintained weight loss	Δenergy intake between standard appetite probe day and random appetite probe day before initiating the intervention vs. Δbody weight before initiating the intervention and after completing the intervention (short term/acute effect on appetite) using data from all subjects (active and standard). Δenergy intake between standard appetite probe day and random appetite probe day after initiating the intervention vs. Δbody weight before initiating the intervention and after completing the intervention (long term effect on appetite) using data from all subjects (active and standard).	First measured after the 8-week Low Calorie Diet period then over the 12-week intervention period

Secondary Outcomes

Measure	Description	Time Frame
Change in subjective appetite related to change in maintained weight loss	Δcomposite subjective appetite ratings as well as Δsatiety and Δfullness ratings between standard appetite probe day and random appetite probe day before initiating the intervention vs. Δbody weight before initiating the intervention and after completing the intervention using data from all subjects (active and standard). Δcomposite subjective appetite ratings or each of the appetite ratings between standard appetite probe day and random appetite probe day after initiating the intervention vs. Δbody weight before initiating the intervention and after completing the intervention (long term effect on appetite) using data from all subjects (active and standard). Ratings of hunger, desire to eat as well as prospective food consumption at standard appetite probe day vs. Δbody weight before initiating the intervention and after completing the intervention

Eligibility Module

Eligibility Criteria

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

ID	Term
D001835	Body Weight
D015431	Weight Loss

ID	Term
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms
D001836	Body Weight Changes