NCT05095038

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

A Six Month Randomized Placebo-controlled Trial of Appethyl® vs Placebo in Management of Pre-diabetes on Overweight and Obese Individuals

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 82 (actual)
• Sponsor: University of Copenhagen · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Appethyl®	Spinach extract, capsules, 5g/day, 26 weeks.
DIETARY_SUPPLEMENT	Placebo	Pea protein, capsules, 5g/day, 26 weeks.

Timeline

• Start date: 2022-02-10
• Primary completion: 2023-06-21
• Completion: 2023-06-21
• First posted: 2021-10-27
• Last updated: 2023-07-03

Locations

1 site across 1 country: Denmark