Effects of Almonds in Glucose-intolerant Adults (AGAMEMNON)

NCT06413069 | Recruiting

• 1 other identifier: AGAMEMNON
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

PreDiabetes; NAFLD

Keywords

almonds; dietary treatment; diabetes prevention; metabolic syndrome

Outcome Measures

Primary Outcomes (3)

• Liver fat content

  change in liver fat content (magnetic resonance spectroscopy)

  16 weeks

• concentration of fasting plasma glucose

  change in concentration of fasting plasma glucose

  16 weeks

• concentration of 2-h plasma glucose (75 g oGTT)

  change in concentration of 2-h plasma glucose (75 g oGTT)

  16 weeks

Secondary Outcomes (14)

• whole body fat content (%; measured with BIA)

  16 weeks

• whole body fat content (kg; measured with BIA)

  16 weeks

• insulin sensitivity (Matsuda)

  16 weeks

• insulin secretion capacity (disposition index-2); metric parameter without defined maxima or minima; higher values indicate better insulin secretion

  16 weeks

• blood pressure (sys/dia)

  16 weeks

Study Arms (2)

Almond treatment

ACTIVE COMPARATOR

Subjects will be supplemented with 60 grams of almonds (treatment) or left untreated (no-nut group) for 16 weeks.

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.

Interventions

Raw whole almonds DIETARY_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.

Almond treatment

Eligibility Criteria

• Age: 35 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• prediabetes (IFG or IGT or IFG-IGT), measured in plasma samples
• NAFLD (MR-S: \>5,56 %)
• BMI between 25 and 40 kg/m²

You may not qualify if:

• 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

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead
• Almond Board of California: collaborator

Study Sites (1)

Charite University Hospital Berlin

Berlin, 12203, Germany

RECRUITING

MeSH Terms

Conditions

Prediabetic State; Non-alcoholic Fatty Liver Disease; Metabolic Syndrome

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Fatty Liver; Liver Diseases; Digestive System Diseases; Insulin Resistance; Hyperinsulinism

Central Study Contacts

Stefan Kabisch, Dr. med.

CONTACT

0049-30-450514; stefan.kabisch@charite.de

Felizitas Kalinowski

CONTACT

0049-30450514; felizitas.kalinowski@charite.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: masking not possible; subjects are aware of their allocation after initiation of the intervention
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: parallel, single-blinded, prospective, randomised controlled trial in waiting list design

Study Record Dates

• First Submitted: January 29, 2024
• First Posted: May 14, 2024
• Study Start: May 23, 2024
• Primary Completion: April 1, 2026
• Study Completion: July 1, 2026
• Last Updated: May 24, 2024

Record last verified: 2024-05

Locations

DE (1)