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

NCT05095038 | Terminated

• 2 other identifiers: B368H-21045373
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

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.

Conditions

Overweight and Obesity; PreDiabetes

Keywords

Appetite; Bodyweight; Fasting blood glucose; Blood lipids; Body composition

Outcome Measures

Primary Outcomes (1)

• Fasting blood glucose

  To investigate the effect over time of daily Appethyl® treatment compared to placebo on change in fasting glucose.

  Change from baseline (week 0) to end of intervention (week 26)

Secondary Outcomes (12)

• Change in bodyweight

  Change from baseline (week 0) to end of intervention (week 26)

• Change in fasting Insulin

  Change from baseline (week 0) to end of intervention (week 26)

• Change in hbA1c

  Change from baseline (week 0) to end of intervention (week 26)

• Change in anthropometrics

  Change from baseline (week 0) to end of intervention (week 26)

• Change in body composition

  Change from baseline (week 0) to end of intervention (week 26)

Study Arms (2)

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.

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.

Dietary Supplement: Placebo

Interventions

Appethyl® DIETARY_SUPPLEMENT

Spinach extract, capsules, 5g/day, 26 weeks.

Appethyl®

Placebo DIETARY_SUPPLEMENT

Pea protein, capsules, 5g/day, 26 weeks.

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Copenhagen: lead
• Greenleaf Medical AB, Lund, Sweden: collaborator
• Lund University: collaborator

Study Sites (1)

University of Copenhagen

Frederiksberg, DK, 1958, Denmark

Location

MeSH Terms

Conditions

Overweight; Obesity; Prediabetic State

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases

Study Officials

• Faidon Magkos, PhD

  University of Copenhagen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Associate Professor

Study Record Dates

• First Submitted: September 22, 2021
• First Posted: October 27, 2021
• Study Start: February 10, 2022
• Primary Completion: June 21, 2023
• Study Completion: June 21, 2023
• Last Updated: July 3, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)