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

NCT05095038 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 82

Last updated 2023-07-03

No results posted yet for this study

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

Interventions

DIETARY_SUPPLEMENT

Appethyl®

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

DIETARY_SUPPLEMENT

Placebo

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

Sponsors & Collaborators

  • Greenleaf Medical AB, Lund, Sweden

    collaborator UNKNOWN

  • Lund University

    collaborator OTHER

  • University of Copenhagen

    lead OTHER

Principal Investigators

  • Faidon Magkos, PhD · University of Copenhagen

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-02-10
Primary Completion
2023-06-21
Completion
2023-06-21

Countries

  • Denmark

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05095038 on ClinicalTrials.gov