Actively Recruiting
Effects of Almonds in Glucose-intolerant Adults (AGAMEMNON)
Led by Charite University, Berlin, Germany · Updated on 2024-05-24
150
Participants Needed
1
Research Sites
109 weeks
Total Duration
On this page
Sponsors
C
Charite University, Berlin, Germany
Lead Sponsor
A
Almond Board of California
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Effects of Almonds in Glucose-intolerant Adults (AGAMEMNON)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 35 to 70 years
- Diagnosed with prediabetes (impaired fasting glucose or impaired glucose tolerance)
- Diagnosed with non-alcoholic fatty liver disease (NAFLD) with liver fat >5.56%
- Body mass index (BMI) between 25 and 40 kg/m²
You will not qualify if you...
- Currently treated with antidiabetic drugs
- Diagnosed with any type of overt diabetes mellitus
- Severe cardiovascular or lung diseases
- Kidney disease or renal insufficiency with eGFR < 60 ml/min/m²
- Severe psychiatric disorders such as schizophrenia, severe depression, or eating disorders
- Current or recent cancer diagnosis within the last 5 years
- Liver diseases other than NAFLD
- Use of corticosteroid medications
- History of alcohol abuse
- Current smoker
- Currently undergoing or finished weight loss within the past 3 months
- Participation in other intervention studies
- Pregnant
- Presence of metal implants or claustrophobia
- Allergy to almonds
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Charite University Hospital Berlin
Berlin, Germany, 12203
Actively Recruiting
Research Team
S
Stefan Kabisch, Dr. med.
CONTACT
F
Felizitas Kalinowski
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here