Effects of Almonds in Glucose-intolerant Adults - a Randomised Controlled Study on Muscle Mass and Obesity, Energy Metabolism and Lipidome, NON-alcoholic Fatty Liver and Inflammation (AGAMEMNON)

Status: Recruiting
Location: See location...
Intervention Type: Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Tree nuts - such as almonds - contribute to beneficial effects of the Mediterranean diet on risk for cardiovascular events, type 2 diabetes, dyslipidemia, hypertension, inflammation and non-alcoholic fatty liver disease. Almonds provide few carbohydrates, but lots of unsaturated fat and dietary fiber. But to which extent and by which mechanisms may almonds improve all aspects of the Metabolic Syndrome? Previous clinical trials showed weaker effects than rodent studies, most possibly due to low statistical power and metabolically insusceptible patients. The 3-year AGAMEMNON project aims to investigate, if 16 weeks of supplementation with almonds (vs. no treatment) in 150 patients with prediabetes and NAFLD leads to significant improvements in glycemia and liver fat, lipid metabolism, body composition and inflammation. The isocaloric design will outrule effects of weight loss and will allow the analysis of metabolic pathways between fat depots, inflammation, insulin resistance and gut function. Lipidomics are assessed as novel predictor of disease progression and metabolic response.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 35
Maximum Age: 70
Healthy Volunteers: f
View:

• prediabetes (IFG or IGT or IFG-IGT), measured in plasma samples

• NAFLD (MR-S: \>5,56 %)

• BMI between 25 and 40 kg/m²

Locations
Other Locations
Germany
Charite University Hospital Berlin
RECRUITING
Berlin
Contact Information
Primary
Stefan Kabisch, Dr. med.
stefan.kabisch@charite.de
0049-30-450514
Backup
Felizitas Kalinowski
felizitas.kalinowski@charite.de
0049-30450514
Time Frame
Start Date: 2024-05-23
Estimated Completion Date: 2026-07-01
Participants
Target number of participants: 150
Treatments
Active_comparator: Almond treatment
Subjects will be supplemented with 60 grams of almonds (treatment) or left untreated (no-nut group) for 16 weeks.
No_intervention: Control condition
Patients of the no-nut group will receive 6,7 kgs of almonds after completing 16 weeks of waiting time, supporting their compliance as untreated group.
Sponsors
Collaborators: Almond Board of California
Leads: Charite University, Berlin, Germany

This content was sourced from clinicaltrials.gov