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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
All
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Secondary Outcome(s)
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Biomarkers of appetite/metabolomics (Method: LC; units: mM; part 1)
[Time Frame: Measured before the 8-week Low Calorie Diet period then after the 8-week Low Calorie Diet period and then after the 12-week intervention period]
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Biomarkers of appetite/metabolomics (Method: LC; units: ng/ml)
[Time Frame: Measured before the 8-week Low Calorie Diet period then after the 8-week Low Calorie Diet period and then after the 12-week intervention period]
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Biomarkers of appetite/metabolomics (Method: MAGPIX; units: ng//mL)
[Time Frame: Measured before the 8-week Low Calorie Diet period then after the 8-week Low Calorie Diet period and then after the 12-week intervention period]
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Biomarkers of appetite/metabolomics (Method: standard enzymatic methods; units: mU/mL)
[Time Frame: Measured before the 8-week Low Calorie Diet period then after the 8-week Low Calorie Diet period and then after the 12-week intervention period]
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Consumer benefits - Craving for Sweet Foods
[Time Frame: Measured before the 8-week Low Calorie Diet period then after the 8-week Low Calorie Diet period and then after the 12-week intervention period]
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Consumer benefits - Eating Self Efficacy Scale (ESES)
[Time Frame: Measured before the 8-week Low Calorie Diet period then after the 8-week Low Calorie Diet period and then after the 12-week intervention period]
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Consumer benefits - Dutch Eating Behaviour Questionnaire (DEBQ)
[Time Frame: Measured before the 8-week Low Calorie Diet period then after the 8-week Low Calorie Diet period and then after the 12-week intervention period]
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Consumer benefits - Hospital Anxiety and Depression Scale (HADS)
[Time Frame: Measured before the 8-week Low Calorie Diet period then after the 8-week Low Calorie Diet period and then after the 12-week intervention period]
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Consumer benefits - Weight Self Efficacy Scale (WSES)
[Time Frame: Measured before the 8-week Low Calorie Diet period then after the 8-week Low Calorie Diet period and then after the 12-week intervention period]
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Biomarkers of appetite/metabolomics (Method: NMR; units; mM)
[Time Frame: Measured before the 8-week Low Calorie Diet period then after the 8-week Low Calorie Diet period and then after the 12-week intervention period]
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Change in body composition
[Time Frame: Measured before the 8-week Low Calorie Diet period then after the 8-week Low Calorie Diet period and then after the 12-week intervention period]
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Biomarkers of appetite/metabolomics (Method: LC; units: uM; part 1)
[Time Frame: Measured before the 8-week Low Calorie Diet period then after the 8-week Low Calorie Diet period and then after the 12-week intervention period]
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Biomarkers of appetite/metabolomics (Method: GC; units: mM)
[Time Frame: Measured before the 8-week Low Calorie Diet period then after the 8-week Low Calorie Diet period and then after the 12-week intervention period]
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Consumer benefits - Extended Satisfaction with Life Scale (ESWLS)
[Time Frame: Measured before the 8-week Low Calorie Diet period then after the 8-week Low Calorie Diet period and then after the 12-week intervention period]
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Biomarkers of appetite/metabolomics (Method: standard enzymatic methods; units: mg/dL)
[Time Frame: Measured before the 8-week Low Calorie Diet period then after the 8-week Low Calorie Diet period and then after the 12-week intervention period]
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Consumer benefits - Impact of Weight on Quality of Life-Lite (IWQOL)
[Time Frame: Measured before the 8-week Low Calorie Diet period then after the 8-week Low Calorie Diet period and then after the 12-week intervention period]
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Biomarkers of appetite/metabolomics (Method: LC; units: uM; part 2)
[Time Frame: Measured before the 8-week Low Calorie Diet period then after the 8-week Low Calorie Diet period and then after the 12-week intervention period]
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Biomarkers of appetite/metabolomics (Method: NMR; units: % of FA Chains)
[Time Frame: Measured before the 8-week Low Calorie Diet period then after the 8-week Low Calorie Diet period and then after the 12-week intervention period]
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Consumer benefits - Positive and Negative Affect Schedule (PANAS)
[Time Frame: Measured before the 8-week Low Calorie Diet period then after the 8-week Low Calorie Diet period and then after the 12-week intervention period]
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Biomarkers of appetite/metabolomics (Method: standard enzymatic methods; units: U/L)
[Time Frame: Measured before the 8-week Low Calorie Diet period then after the 8-week Low Calorie Diet period and then after the 12-week intervention period]
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Consumer benefits - Pitsburg Sleep Quality Index
[Time Frame: Measured before the 8-week Low Calorie Diet period then after the 8-week Low Calorie Diet period and then after the 12-week intervention period]
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Change in subjective appetite related to change in maintained weight loss
[Time Frame: : First measured after the 8-week Low Calorie Diet period then after the 12-week intervention period]
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Consumer benefits - Mindful Eating Scale (MES)
[Time Frame: Measured before the 8-week Low Calorie Diet period then after the 8-week Low Calorie Diet period and then after the 12-week intervention period]
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Consumer benefits - Self-consciousness scale (SCSR)
[Time Frame: Measured before the 8-week Low Calorie Diet period then after the 8-week Low Calorie Diet period and then after the 12-week intervention period]
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Consumer benefits - Three Factor Eating Questionnaire (TFEQ)
[Time Frame: Measured before the 8-week Low Calorie Diet period then after the 8-week Low Calorie Diet period and then after the 12-week intervention period]
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Consumer benefits - Food Thought Suppression Inventory
[Time Frame: Measured before the 8-week Low Calorie Diet period then after the 8-week Low Calorie Diet period and then after the 12-week intervention period]
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Consumer benefits - Perceived Stress Scale
[Time Frame: Measured before the 8-week Low Calorie Diet period then after the 8-week Low Calorie Diet period and then after the 12-week intervention period]
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To test if subjects receiving the active products (enhanced satiating power) will have a better weight-maintenance compared to subjects receiving control products (standard products). This will be tested with the 3 products combined in the main study.
[Time Frame: First measured after the 8-week Low Calorie Diet period then after the 12-week intervention period]
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Consumer benefits - Warwick Edinburgh Mental Well Being Scale (WEMWBS)
[Time Frame: Measured before the 8-week Low Calorie Diet period then after the 8-week Low Calorie Diet period and then after the 12-week intervention period]
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Biomarkers of appetite/metabolomics (Method: LC; units: mM; part 2)
[Time Frame: Measured before the 8-week Low Calorie Diet period then after the 8-week Low Calorie Diet period and then after the 12-week intervention period]
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Biomarkers of appetite/metabolomics (Method: MAGPIX; units: pg//mL)
[Time Frame: Measured before the 8-week Low Calorie Diet period then after the 8-week Low Calorie Diet period and then after the 12-week intervention period]
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Biomarkers of appetite/metabolomics (Method: MAGPIX; units: ug//mL)
[Time Frame: Measured before the 8-week Low Calorie Diet period then after the 8-week Low Calorie Diet period and then after the 12-week intervention period]
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Consumer benefits - Control of Eating Questionnaire (CoEQ)
[Time Frame: Measured before the 8-week Low Calorie Diet period then after the 8-week Low Calorie Diet period and then after the 12-week intervention period]
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Consumer benefits - International Physical Activity Questionnaire (IPAQ)
[Time Frame: Measured before the 8-week Low Calorie Diet period then after the 8-week Low Calorie Diet period and then after the 12-week intervention period]
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Consumer benefits - Power of Food Scale (PFS)
[Time Frame: Measured before the 8-week Low Calorie Diet period then after the 8-week Low Calorie Diet period and then after the 12-week intervention period]
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Consumer benefits - Self Report Measure of Quality of Life (EQ-5D)
[Time Frame: Measured before the 8-week Low Calorie Diet period then after the 8-week Low Calorie Diet period and then after the 12-week intervention period]
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