Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT06413069 |
| Other study ID # |
AGAMEMNON |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
May 23, 2024 |
| Est. completion date |
July 1, 2026 |
Study information
| Verified date |
May 2024 |
| Source |
Charite University, Berlin, Germany |
| Contact |
Stefan Kabisch, Dr. med. |
| Phone |
0049-30-450514 |
| Email |
stefan.kabisch[@]charite.de |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
Description:
Background / Significance:
T2D affects 5-10 % of the global population, challenging societies, health systems, economy
and quality of life. Dietary treatment may avoid disease burdens, save money and protect
general health resources, but is often limited to unspecific weight loss recommendations and
advise for physical activity. Despite being the common advice, body weight reduction is faced
with inconclusive evidence for its impact on long-term risks (obesity paradox?), lack of
long-term compliance and irresponsive or ineligible subgroups of patients. The Mediterranean
diet provides the ideal dietary composition and reduces CVD risk, improving every axis of the
Metabolic Syndrome, including liver fat. It is unclear, though, to which extent tree nuts
contribute to this effect.
In meta-analyses, almonds improve glycemia and lipids. Benefits on body composition and
inflammation are also expected, these might extend to NAFLD.
n6-PUFAs (typical components of tree nuts) reduce T2D risk and liver fat in humans. This was
shown for sunflower oil, but not yet for nuts. Evidence for NAFLD benefits by almonds in
humans is limited to observational studies, post-hoc analyses of mixed interventions, and
underpowered RCTs.
Aims / Rationale:
Nuts are safe for NAFLD patients. Previous data indicate, that almonds may elicit benefits on
glycemia and liver fat in patients susceptible to this treatment.
Therefore, the investigators' project aims to investigate whole almonds as dietary treatment
for glucose intolerance and NAFLD in patients with this typical combined phenotype. NAFLD
independently predicts T2D progression and late complications. (Pre)diabetes patients with
NAFLD are at higher risk for the entire metabolic syndrome and for early onset of nephropathy
and CVD. On the other hand, prediabetes/T2D patients with NAFLD are also especially
susceptible to lifestyle treatments. The investigators hypothesize to detect benefits of
almonds with respect to glycemia and liver fat, but also lipid metabolism, body composition
and inflammation compared to standard diet. Treatment period of 16 weeks is longer than
earlier almond studies.
The investigators intend to show, that the metabolic improvement is independent from weight
loss and, even in the opposite, supports maintenance of muscle mass. The research group wants
to investigate mechanistic links between the metabolic pathways of visceral fat accumulation,
inflammation, NAFLD, insulin resistance, dyslipidemia and the gut microbiome. Finally, the
investigators aim to assess the lipidome (analysed from the erythrocyte membranes, full blood
and plasma samples), which was recently established as a novel biomarker to predict disease
progression, metabolic response and treatment-specific improvement.
