Investigating the effects of almonds on glucose intolerance in adults
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)
This study is testing whether adding almonds to the diet can help adults with prediabetes and fatty liver disease improve their blood sugar levels and overall health over 16 weeks.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 35 Years to 70 Years |
| Sex | All |
| Sponsor | Charite University, Berlin, Germany Academic / other |
| Locations | 1 site (Berlin) |
| Trial ID | NCT06413069 on ClinicalTrials.gov |
What this trial studies
This project examines the impact of 16 weeks of almond supplementation on adults with prediabetes and non-alcoholic fatty liver disease (NAFLD). The study will involve 150 participants and aims to assess improvements in glycemia, liver fat, lipid metabolism, body composition, and inflammation, while controlling for weight loss effects. By focusing on the metabolic pathways influenced by almonds, the research seeks to clarify their role in managing metabolic syndrome. The study is designed to provide more robust evidence than previous trials, which suffered from low statistical power.
Who should consider this trial
Good fit: Ideal candidates for this study are adults with prediabetes and NAFLD, who have a BMI between 25 and 40 kg/m².
Not a fit: Patients with overt diabetes, severe cardiovascular or pulmonary disorders, or those currently using antidiabetic medications will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a dietary intervention that significantly improves metabolic health and reduces the risk of type 2 diabetes and liver disease.
How similar studies have performed: Previous studies have shown some benefits of almonds on glycemia and lipids, but this approach aims to provide more definitive evidence in a well-defined patient population.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Berlin
- Charite University Hospital Berlin — Berlin, Germany (Recruiting)
Study contacts
- Study coordinator: Stefan Kabisch, Dr. med.
- Email: stefan.kabisch@charite.de
- Phone: 0049-30-450514
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.