NCT06413069 Effects of Almonds in Glucose-intolerant Adults (AGAMEMNON)
| NCT ID | NCT06413069 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Charite University, Berlin, Germany |
| Condition | PreDiabetes |
| Study Type | INTERVENTIONAL |
| Enrollment | 150 participants |
| Start Date | 2024-05-23 |
| Primary Completion | 2026-04-01 |
Trial Parameters
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Brief 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 Criteria
Inclusion Criteria: * prediabetes (IFG or IGT or IFG-IGT), measured in plasma samples * NAFLD (MR-S: \>5,56 %) * BMI between 25 and 40 kg/m² Exclusion Criteria: * Treatment with antidiabetic drugs * Overt diabetes mellitus of any kind * Severe cardiovascular or pulmonary disorder * Renal disorder / Renal insufficiency (eGFR \< 60 ml/min/m²) * Severe psychiatric disorder (schizophrenia, severe depression; eating disorders) * Current or recent (\< 5 years) cancer diagnosis * Liver disease other than NAFLD * Use of corticosteroid treatments * Alcohol abuse * Smoking * Ongoing or recently finished (3 months before) weight loss * Current participation in other intervention studies * Pregnancy * Metal implants, claustrophobia * Allergy to almonds
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