PreDiabetesAGAMEMNONNCT06413069
Effects of Almonds in Glucose-intolerant Adults (AGAMEMNON)
A study testing Raw whole almonds in people with PreDiabetes and NAFLD, run by Charite University, Berlin, Germany at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 35 to 70 years
- Conditions the study is for
- PreDiabetes, NAFLD
- What is being tested?
- Raw whole almonds
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteGermany
- Study dates
- 23 May 2024to 1 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- prediabetes (IFG or IGT or IFG-IGT), measured in plasma samples
- NAFLD (MR-S: >5,56 %)
- BMI between 25 and 40 kg/m²
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Charite University Hospital Berlin
Berlin, 12203
Stefan Kabisch, Dr. med., 030 450 514 429, stefan.kabisch@charite.de
About this study
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)
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.
Read the 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. (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.
- Conditions
- PreDiabetes, NAFLD
- Being tested
- Raw whole almonds
- Keywords
- almonds, dietary treatment, diabetes prevention, metabolic syndrome
- Medical subject headings
- Prediabetic State, Non-alcoholic Fatty Liver Disease, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Raw whole almondsDietary supplement
Subjects will be supplemented with 60 grams of almonds (treatment) or left untreated (no-nut group) for 16 weeks. Patients of the no-nut group will receive 6,7 kgs of almonds after finishing the study, supporting their compliance as untreated group.
| Study group | Role | What they receive |
|---|---|---|
| Almond treatment | Active comparator | Subjects will be supplemented with 60 grams of almonds (treatment) or left untreated (no-nut group) for 16 weeks. Receives: Dietary Supplement: Raw whole almonds |
| Control condition | No intervention | Patients of the no-nut group will receive 6,7 kgs of almonds after completing 16 weeks of waiting time, supporting their compliance as untreated group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Liver fat content
change in liver fat content (magnetic resonance spectroscopy)
Measured: 16 weeks
concentration of fasting plasma glucose
change in concentration of fasting plasma glucose
Measured: 16 weeks
concentration of 2-h plasma glucose (75 g oGTT)
change in concentration of 2-h plasma glucose (75 g oGTT)
Measured: 16 weeks
Secondary outcomes (14)
whole body fat content (%; measured with BIA)
change in whole body fat content
Measured: 16 weeks
whole body fat content (kg; measured with BIA)
change in whole body fat content
Measured: 16 weeks
insulin sensitivity (Matsuda)
change in insulin sensitivity (Matsuda)
Measured: 16 weeks
insulin secretion capacity (disposition index-2); metric parameter without defined maxima or minima; higher values indicate better insulin secretion
change in insulin secretion capacity (disposition index-2); metric parameter without defined maxima or minima; higher values indicate better insulin secretion
Measured: 16 weeks
blood pressure (sys/dia)
change in blood pressure (sys/dia)
Measured: 16 weeks
serum concentration of CRP
change in serum concentration of CRP
Measured: 16 weeks
serum concentration of IL-6
change in serum concentration of IL-6
Measured: 16 weeks
serum concentration of IL-10
change in serum concentration of IL-10
Measured: 16 weeks
serum concentration of IL-1ß
change in serum concentration of IL-1ß
Measured: 16 weeks
serum concentration of IL-18
change in serum concentration of IL-18
Measured: 16 weeks
serum concentration of IL-22
change in serum concentration of IL-22
Measured: 16 weeks
fasting triglyceride levels
change in fasting triglyceride levels
Measured: 16 weeks
LDL, HDL, LDL/HDL ratio
change in LDL, HDL, LDL/HDL ratio
Measured: 16 weeks
concentration of serum lipidome parameters (hundreds of lipid species)
change in serum lipidome (hundreds of lipid species)
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2024
- Study start23 May 2024
- Primary completion1 Apr 2026 (estimated)
- Study completion1 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PreDiabetesStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- parallel, single-blinded, prospective, randomised controlled trial in waiting list design
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Collaborators
- Almond Board of California
- Responsible party
- Principal investigator, Stefan Kabisch, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06413069
- Sponsor's protocol ID
- AGAMEMNON
- Acronym
- AGAMEMNON
- Status last verified
- May 2024
- First submitted
- 29 Jan 2024
- Last updated
- 24 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT06413069
- Acronym / sponsor ID
- AGAMEMNON / AGAMEMNON
- Conditions
- PreDiabetes, NAFLD
- Keywords
- almonds, dietary treatment, diabetes prevention, metabolic syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Collaborators
- Almond Board of California
- Study start
- 23 May 2024 (actual)
- Primary completion
- 1 Apr 2026 (estimated)
- Study completion
- 1 Jul 2026 (estimated)
- First posted
- 14 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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. (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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- parallel, single-blinded, prospective, randomised controlled trial in waiting list design
| Arm | Type | Receives |
|---|---|---|
| Almond treatment | Active comparator | Dietary Supplement: Raw whole almondsSubjects will be supplemented with 60 grams of almonds (treatment) or left untreated (no-nut group) for 16 weeks. |
| Control condition | No intervention | –Patients of the no-nut group will receive 6,7 kgs of almonds after completing 16 weeks of waiting time, supporting their compliance as untreated group. |
Who may qualify
- Ages
- 35 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- prediabetes (IFG or IGT or IFG-IGT), measured in plasma samples
- NAFLD (MR-S: >5,56 %)
- BMI between 25 and 40 kg/m²
Key exclusion criteria (15 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Raw whole almondsSubjects will be supplemented with 60 grams of almonds (treatment) or left untreated (no-nut group) for 16 weeks. Patients of the no-nut group will receive 6,7 kgs of almonds after finishing the study, supporting their compliance as untreated group. | Dietary supplement | Almond treatment |
Primary outcome
Liver fat content
Time frame: 16 weeks
change in liver fat content (magnetic resonance spectroscopy)
concentration of fasting plasma glucose
Time frame: 16 weeks
change in concentration of fasting plasma glucose
concentration of 2-h plasma glucose (75 g oGTT)
Time frame: 16 weeks
change in concentration of 2-h plasma glucose (75 g oGTT)
14 secondary outcomes
whole body fat content (%; measured with BIA)
Time frame: 16 weeks
whole body fat content (kg; measured with BIA)
Time frame: 16 weeks
insulin sensitivity (Matsuda)
Time frame: 16 weeks
insulin secretion capacity (disposition index-2); metric parameter without defined maxima or minima; higher values indicate better insulin secretion
Time frame: 16 weeks
blood pressure (sys/dia)
Time frame: 16 weeks
serum concentration of CRP
Time frame: 16 weeks
serum concentration of IL-6
Time frame: 16 weeks
serum concentration of IL-10
Time frame: 16 weeks
serum concentration of IL-1ß
Time frame: 16 weeks
serum concentration of IL-18
Time frame: 16 weeks
serum concentration of IL-22
Time frame: 16 weeks
fasting triglyceride levels
Time frame: 16 weeks
LDL, HDL, LDL/HDL ratio
Time frame: 16 weeks
concentration of serum lipidome parameters (hundreds of lipid species)
Time frame: 16 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Raw whole almonds in people with PreDiabetes and NAFLD, run by Charite University, Berlin, Germany at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Stefan Kabisch, Dr. med. (0049-30-450514 ext. 429, stefan.kabisch@charite.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Liver fat content (time frame: 16 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2024.