Ignite Creation Date:
2024-05-19 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06413069
Status:
RECRUITING
Last Update Posted:
2024-05-24
First Post:
2024-01-29
Brief Title:
Effects of Almonds in Glucose-intolerant Adults AGAMEMNON
Sponsor:
Charite University Berlin Germany
Organization:
Charite University Berlin Germany
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AGAMEMNON
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
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
Detailed 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 Prediabetes patients with NAFLD are at higher risk for the entire metabolic syndrome and for early onset of nephropathy and CVD On the other hand prediabetesT2D 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
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 Prediabetes patients with NAFLD are at higher risk for the entire metabolic syndrome and for early onset of nephropathy and CVD On the other hand prediabetesT2D 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None