The Effect of Appethyl® vs Placebo on Human Health (Appethyl)

University of Copenhagen

Status

Terminated

Conditions

Overweight and Obesity

PreDiabetes

Treatments

Dietary Supplement: Appethyl®

Dietary Supplement: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT05095038

B368

H-21045373 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment

82 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

82 participants in 2 patient groups, including a placebo group

Appethyl®

Experimental group

Description:

Participants are instructed to ingest 10 capsules daily and they are instructed to swallow the capsules in whole with a glass of water with/during lunchtime throughout the study period of 26 weeks. Each capsule contain 0.5 g Appethyl®, and the daily intake is 5 g/day.

Treatment:

Dietary Supplement: Appethyl®

Placebo

Placebo Comparator group

Description:

Treatment:

Dietary Supplement: Placebo