Clinical trial NCT05095038: The Effect of Appethyl® vs Placebo on Human Health (Appethyl)
Official title: A Six Month Randomized Placebo-controlled Trial of Appethyl® vs Placebo in Management of Pre-diabetes on Overweight and Obese Individuals
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Overweight and Obesity
PreDiabetes
Keywords: Appetite
Bodyweight
Fasting blood glucose
Blood lipids
Body composition
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
Collaborators: name: Greenleaf Medical AB, Lund, Sweden
name: Lund University
First posted: 2021-10-27
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The study will be conducted as a 26-week double-blinded randomized placebo-controlled trial of Appethyl® vs placebo in 100 overweight/obese (BMI ≥25.0-35.9 kg/m\^2) men and women between 18-65 years with prediabetes (fasting plasma glucose of 5.6 mmol/L to \<7.0 mmol/L). At initiation, all subjects will receive healthy life style instructions in accordance to the guidelines described in the Nordic Nutrition Recommendations.

The study aim to investigate the effect over time (26-weeks) of daily Appethyl® treatment compared to placebo on change in fasting glucose (primary endpoint) and several other health markers (secondary endpoint).

The hypothesis to be tested is whether the null hypothesis (no difference between Appethyl® and placebo with regard to endpoint data) can be rejected.


Eligibility criteria: Inclusion Criteria:

* Male and women Age between 18-65 years
* BMI ≥25.0-35.9 kg/m\^2
* Prediabetes (defined according to ADA with a fasting plasma glucose of 5.6 mmol/L to \<7.0 mmol/L)
* Provided voluntary written informed consent

Exclusion Criteria:

* Non-covid-19 vaccinated
* Known diseases which may affect energy expenditure and/or satiation/satiety/food intake
* History or diagnosis of eating disorder
* Any physical abnormality or medical condition which might have impact on following the dietary regimen
* Psychiatric disorders i.e. schizophrenia, bipolar disease or depression with hospitalization within the last 6 months
* Diabetes mellitus (type 1 and 2)
* History or diagnosis of cardiovascular disease, chronic kidney disease, liver disease and cancer
* Known 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 three months is required
* Active inflammatory bowel disease, celiac disease, chronic pancreatitis or other disorder potentially causing malabsorption
* Systemic treatment with glucocorticoids inhalations and creams etc. is allowed
* 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
* Current use of other prescription medication that does not affect body weight should have been stable for the past three months and expected to be stable during the study
* Concurrent therapy with immunosuppressive drugs or cytotoxic agents
* Hemoglobin concentration below local laboratory reference values (i.e. anemia)
* Being lactating, pregnant or planning to become pregnant within the study period
* Weight changes ± 5% three months prior inclusion
* Dietary patterns interfering with the study protocol, as judged by the investigator, two months prior inclusion, during the study or plans to initiate during the study
* Use of pre- and probiotic products (incl. fiber supplements) within one month prior to study initiation as well as during the study (except psyllium 10 g/day)
* Use of dietary supplementation should be stable three months prior to study initiation as well as during the study
* Severe food allergies and food intolerances expected to interfere with the study
* Intolerance, allergy or dislike of intervention products (e.g. pea allergy)
* Engagement in elite sports or similar strenuous exercise ≥5 h/week
* Blood donation or transfusion within the past month before screening
* Planned blood donation for other purpose than this study during participation
* Consumption of alcohol corresponding to \>2 (for men) and \>1 (for women) units/day
* Drug abuse, as judged by the investigator, within the previous 12 months
* Psychological or behavioral problems which, in the judgement of the investigator, would lead to difficulty in complying with the study protocol
* 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
* Unable to consume the interventional product 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 given by the study personnel
* Illiteracy or inadequate understanding of Danish/Scandinavia
* Any other condition that judged by the investigator may interfere with the adherence to the study protocol

Primary outcomes:
measure: Fasting blood glucose
timeFrame: Change from baseline (week 0) to end of intervention (week 26)
Secondary outcomes:
measure: Change in bodyweight
timeFrame: Change from baseline (week 0) to end of intervention (week 26)
measure: Change in fasting Insulin
timeFrame: Change from baseline (week 0) to end of intervention (week 26)
measure: Change in hbA1c
timeFrame: Change from baseline (week 0) to end of intervention (week 26)
measure: Change in anthropometrics
timeFrame: Change from baseline (week 0) to end of intervention (week 26)
measure: Change in body composition
timeFrame: Change from baseline (week 0) to end of intervention (week 26)
measure: Change in inflammation
timeFrame: Change from baseline (week 0) to end of intervention (week 26)
measure: Change in blood lipids
timeFrame: Change from baseline (week 0) to end of intervention (week 26)
measure: Change in blood pressure
timeFrame: Change from baseline (week 0) to end of intervention (week 26)
measure: Change in pulse
timeFrame: Change from baseline (week 0) to end of intervention (week 26)
measure: Change in the proportion of participants converting to normoglycemia
timeFrame: Change from baseline (week 0) to end of intervention (week 26)
measure: Change in subjective assessment of dietary preferences
timeFrame: Change from baseline (week 0) to end of intervention (week 26)
measure: Change in subjective assessment of investigational product
timeFrame: Change from baseline (week 0) to end of intervention (week 26)
Other outcomes:
Locations:
city: Frederiksberg
country: Denmark
facility: University of Copenhagen
state: DK
Study officials:
affiliation: University of Copenhagen
name: Faidon Magkos, PhD
role: PRINCIPAL_INVESTIGATOR
References: