Overweight and ObesityNCT05095038
The Effect of Appethyl® vs Placebo on Human Health (Appethyl)
A study testing Appethyl® in people with Overweight and Obesity and PreDiabetes, run by University of Copenhagen at 1 site in Denmark.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight and Obesity, PreDiabetes
- What is being tested?
- Appethyl®
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 82 participants
- Where
- 1 siteDenmark
- Study dates
- 10 Feb 2022to 21 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 38Show fewer
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: A Six Month Randomized Placebo-controlled Trial of Appethyl® vs Placebo in Management of Pre-diabetes on Overweight and Obese Individuals
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.
- Conditions
- Overweight and Obesity, PreDiabetes
- Being tested
- Appethyl®, Placebo
- Keywords
- Appetite, Bodyweight, Fasting blood glucose, Blood lipids, Body composition
- Medical subject headings
- Overweight, Obesity, Prediabetic State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Appethyl®Dietary supplement
Spinach extract, capsules, 5g/day, 26 weeks.
PlaceboDietary supplement
Pea protein, capsules, 5g/day, 26 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Appethyl® | Experimental | 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. Receives: Dietary Supplement: Appethyl® |
| Placebo | Placebo comparator | 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 placebo, and the daily intake is 5 g/day. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fasting blood glucose
To investigate the effect over time of daily Appethyl® treatment compared to placebo on change in fasting glucose.
Measured: Change from baseline (week 0) to end of intervention (week 26)
Secondary outcomes (12)
Change in bodyweight
Body weight will be measured at baseline (week 0), week 12 and after end of intervention (week 26) in a fasting state. Body weight will be measured wearing only underwear or light clothing as well as no shoes and stockings. Body weight will be measured on a calibrated scale and subjects will be instructed to stand in the middle of the platform of the scale with straight neck and eyes looking straight ahead, whilst distributing their weight evenly on body feet after having emptied their bladder. Two measurements are made when the scale has stabilized and both results are recorded to the nearest 0.1 kg and the average of the two measurements is used for further analysis.
Measured: Change from baseline (week 0) to end of intervention (week 26)
Change in fasting Insulin
Venous blood samples will be collected at baseline (week 0), week 12 and after end of intervention (week 26) by a vein puncture in the antecubital vein after an overnight fast from at least 10 pm the night before. HOMA-IR and HOMA-IS will be calculated from fasting blood glucose and insulin concentrations.
Measured: Change from baseline (week 0) to end of intervention (week 26)
Change in hbA1c
Venous blood samples will be collected at baseline (week 0), week 12 and after end of intervention (week 26) by a vein puncture in the antecubital vein after an overnight fast from at least 10 pm the night before.
Measured: Change from baseline (week 0) to end of intervention (week 26)
Change in anthropometrics
Waist- and hip circumference will be measured at baseline (week 0), week 12 and after end of intervention (week 26) in a fasting state. The measurements of waist- and hip circumference will be performed with an empty bladder and performed with a non-elastic tape measuring. Waist circumference is measured mid-way between the lower rib and iliac crest (top of the hip bone) at the end of expiration with the subject in a standing position with their weight distributed evenly on both feet. Hip circumference is measures at the widest point between the hips and buttocks observed from the front at the end of expiration with the subject in a standing position with their weight distributed evenly on both feet. Two measurements of waist- and hip circumference will be made and both results will be recorded to the nearest 0.5 cm and the average of the two measurements is used in further analysis
Measured: Change from baseline (week 0) to end of intervention (week 26)
Change in body composition
Body composition will be assessed by a whole body DXA scan at baseline (week 0), week 12 and after end of intervention (week 26) assessing lean mass (kg), fat mass (kg), abdominal fat (kg), visceral fat (kg) and bone mineral density (g/cm^2). The DXA scan will be performed in a fasting condition with the subjects only wearing light clothing and after emptying the bladder.
Measured: Change from baseline (week 0) to end of intervention (week 26)
Change in inflammation
Venous blood samples will be collected at baseline (week 0), week 12 and after end of intervention (week 26) by a vein puncture in the antecubital vein after an overnight fast from at least 10 pm the night before. Leptin (pg/ml), adiponectin (ng/ml), IL-6 (pg/ml), TNF-alfa (pg/ml) and hsCRP (mg/L) will be assessed.
Measured: Change from baseline (week 0) to end of intervention (week 26)
Change in blood lipids
Venous blood samples will be collected at baseline (week 0), week 12 and after end of intervention (week 26) by a vein puncture in the antecubital vein after an overnight fast from at least 10 pm the night before. Blood lipids: LDL and TG
Measured: Change from baseline (week 0) to end of intervention (week 26)
Change in blood pressure
Systolic and diastolic blood pressure (mmHg) will be measured at baseline (week 0), week 12 and after end of intervention (week 26) using a validated automatic device. The blood pressure will be measured on the right arm with an appropriate arm cuff after 5-10 min rest in a resting position. The measurement will be performed three times approximately two minutes apart, and the reading is recorded to the nearest 1 mmHg for blood pressure. A mean value of the three readings will be used in further analysis.
Measured: Change from baseline (week 0) to end of intervention (week 26)
Change in pulse
Pulse (beats per minute) will be measured at baseline (week 0), week 12 and after end of intervention (week 26) using a validated automatic device. The pulse will be measured on the right arm with an appropriate arm cuff after 5-10 min rest in a resting position. The measurement will be performed three times approximately two minutes apart, and the reading is recorded to the nearest 1 beats per minute for pulse. A mean value of the three readings will be used in further analysis.
Measured: Change from baseline (week 0) to end of intervention (week 26)
Change in the proportion of participants converting to normoglycemia
Number of participants converting from prediabetes to normal glucose levels
Measured: Change from baseline (week 0) to end of intervention (week 26)
Change in subjective assessment of dietary preferences
Subjective measurements of hunger, satiety, taste for sweet, fat and salt will be assessed by Visual Analogue Scales (VAS) (0-10 cm, where 10 being the highest ranking). The participants will be asked to complete the VAS at baseline (week 0) and at every visit from week 0 to 26 (week 4, 8, 12, 16, 20 and 24). Moreover, every fourth week from week 2 to week 22 (week 2, 6, 10, 14, 18, and 22) participants will be asked to complete the questionnaire regarding subjective assessment of dietary preferences at home. The questionnaire will be handed out prior to completion.
Measured: Change from baseline (week 0) to end of intervention (week 26)
Change in subjective assessment of investigational product
Participants will be asked to answer a questionnaire (on a scale from 1-5 going from very tolerable to very intolerable) regarding their experience of the investigational product at baseline (week 0) and at every visit from week 0 to 26 (week 4, 8, 12, 16, 20 and 24). Moreover, every fourth week from week 2 to 22 (week 2, 6, 10, 14, 18, and 22) participants will be asked to complete the questionnaire regarding subjective assessment of the investigational product at home. The questionnaire will be handed out prior to completion.
Measured: Change from baseline (week 0) to end of intervention (week 26)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2021
- Study start10 Feb 2022
- Primary completion21 Jun 2023
- Study completion21 Jun 2023
Why it stopped: The collaborator providing funding for the study has suspended the payment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight and ObesityStudies of the same condition, open and under way.
- More trials run by University of CopenhagenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- Greenleaf Medical AB, Lund, Sweden, Lund University
- Responsible party
- Principal investigator, Faidon Magkos, University of Copenhagen
- Investigators
- Faidon Magkos, PhD, Principal investigator, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05095038
- Sponsor's protocol ID
- B368
- Other IDs
- H-21045373
- Status last verified
- Jun 2023
- First submitted
- 22 Sep 2021
- Last updated
- 3 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Six Month Randomized Placebo-controlled Trial of Appethyl® vs Placebo in Management of Pre-diabetes on Overweight and Obese Individuals
- ClinicalTrials.gov ID
- NCT05095038
- Acronym / sponsor ID
- B368
- Conditions
- Overweight and Obesity, PreDiabetes
- Keywords
- Appetite, Bodyweight, Fasting blood glucose, Blood lipids, Body composition
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The collaborator providing funding for the study has suspended the payment
- Enrolment
- 82 participants (actual)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Collaborators
- Greenleaf Medical AB, Lund, Sweden, Lund University
- Study start
- 10 Feb 2022 (actual)
- Primary completion
- 21 Jun 2023 (actual)
- Study completion
- 21 Jun 2023 (actual)
- First posted
- 27 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Appethyl® | Experimental | Dietary Supplement: Appethyl®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. |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboParticipants 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 placebo, and the daily intake is 5 g/day. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (38 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Appethyl®Spinach extract, capsules, 5g/day, 26 weeks. | Dietary supplement | Appethyl® |
| PlaceboPea protein, capsules, 5g/day, 26 weeks. | Dietary supplement | Placebo |
Primary outcome
Fasting blood glucose
Time frame: Change from baseline (week 0) to end of intervention (week 26)
To investigate the effect over time of daily Appethyl® treatment compared to placebo on change in fasting glucose.
12 secondary outcomes
Change in bodyweight
Time frame: Change from baseline (week 0) to end of intervention (week 26)
Change in fasting Insulin
Time frame: Change from baseline (week 0) to end of intervention (week 26)
Change in hbA1c
Time frame: Change from baseline (week 0) to end of intervention (week 26)
Change in anthropometrics
Time frame: Change from baseline (week 0) to end of intervention (week 26)
Change in body composition
Time frame: Change from baseline (week 0) to end of intervention (week 26)
Change in inflammation
Time frame: Change from baseline (week 0) to end of intervention (week 26)
Change in blood lipids
Time frame: Change from baseline (week 0) to end of intervention (week 26)
Change in blood pressure
Time frame: Change from baseline (week 0) to end of intervention (week 26)
Change in pulse
Time frame: Change from baseline (week 0) to end of intervention (week 26)
Change in the proportion of participants converting to normoglycemia
Time frame: Change from baseline (week 0) to end of intervention (week 26)
Change in subjective assessment of dietary preferences
Time frame: Change from baseline (week 0) to end of intervention (week 26)
Change in subjective assessment of investigational product
Time frame: Change from baseline (week 0) to end of intervention (week 26)
Results and safety
The study was stopped early (reason given: The collaborator providing funding for the study has suspended the payment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Faidon Magkos, PhD principal investigator
University of Copenhagen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Appethyl® in people with Overweight and Obesity and PreDiabetes, run by University of Copenhagen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 38 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 3 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: The collaborator providing funding for the study has suspended the payment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fasting blood glucose (time frame: Change from baseline (week 0) to end of intervention (week 26)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2023.