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RECRUITING
NCT06413069
NA

Effects of Almonds in Glucose-intolerant Adults (AGAMEMNON)

Sponsor: Charite University, Berlin, Germany

View on ClinicalTrials.gov

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.

Official title: 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)

Key Details

Gender

All

Age Range

35 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

150

Start Date

2024-05-23

Completion Date

2026-07-01

Last Updated

2024-05-24

Healthy Volunteers

No

Interventions

DIETARY_SUPPLEMENT

Raw whole almonds

Subjects will be supplemented with 60 grams of almonds (treatment) or left untreated (no-nut group) for 16 weeks. Patients of the no-nut group will receive 6,7 kgs of almonds after finishing the study, supporting their compliance as untreated group.

Locations (1)

Charite University Hospital Berlin

Berlin, Germany