Health Condition 1: K760- Fatty (change of) liver, not elsewhere classified
Conditions
Interventions
Intervention1: Roasted Unsalted Almonds: Almond intervention low dose
Intervention name: 42 g per day almond group
Detail: Participants receive 42 g (1.5 oz) of roasted, unsalted almonds per day, di
Sponsors
Almond Board California, USA
Eligibility
Inclusion criteria
Inclusion criteria: All participants on USG with Grade 1 (Mild) Hepatic Steatosis Slight increase in liver echogenicity compared with kidney; Normal visualization of diaphragm and intrahepatic vessel borders; No posterior beam attenuation; Liver kidney contrast mildly increased; Definition of Grade 2 (Moderate) Hepatic Steatosis; Moderate, diffuse increase in liver echogenicity; Partial loss of visualization of intrahepatic vessel walls and diaphragm; Mild to moderate posterior beam attenuation; Liver kidney contrast clearly increased;
Exclusion criteria
Exclusion criteria: 1.Diabetes:Participants with diagnosed type 1 or type 2 diabetes who are taking medications. 2. Physical Activity: Individuals engaged in high-intensity athletic training or structured exercise programs (more than 300 minutes/week of vigorous activity) that can independently alter liver fat, visceral adiposity, and metabolic markers. Sedentary or moderately active individuals are eligible. 3.Endocrine Disorders: This includes clinically diagnosed: Hypothyroidism or hyperthyroidism; Polycystic Ovary Syndrome (PCOS); Cushings syndrome; Adrenal or pituitary disorders; Other hormonal disorders requiring long-term medications; These conditions significantly affect lipid metabolism, weight regulation, and hepatic fat accumulation, and would confound intervention effects. 4.Chronic Liver Diseases:Participants with liver disease other than MASLD will be excluded, including: Alcohol-associated liver disease; Viral hepatitis (HBV, HCV); Autoimmune hepatitis; Drug-induced liver injury; Wilson s disease; Hemochromatosis; These conditions independently influence liver fat, fibrosis progression, and liver enzymes, making MASLD-specific effects harder to interpret. 5.History of Allergic Reaction - Specifically refers to: Nut allergies, especially tree-nut (almond) allergy; Severe food allergies requiring medication; History of anaphylaxis or urticaria with nut exposure; This ensures participant safety during the almond supplementation intervention. 6.Other Exclusions Use of dietary supplements (omega-3, vitamin E, probiotics, herbal liver formulations) that may alter metabolic or hepatic outcomes; Excessive alcohol intake: more than or equal to 30 g per day for men and more than or equal to 20 g per day for women; Severe medical illness (renal failure, heart failure, active malignancy); Pregnancy or lactation;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in liver fat (hepatic steatosis), measured using FibroScan Controlled Attenuation Parameter (CAP, dB per m). Visceral adiposity or visceral fat will be treated as a co-primary outcome, assessed using DXA-derived abdominal or visceral fat measures.Timepoint: Baseline at Week 0 Endline at Week 16 | — |
Secondary
| Measure | Time frame |
|---|---|
| Glucose homeostasis and insulin sensitivity: fasting blood glucose, fasting insulin, HOMA-IR, and HbA1c.Timepoint: Baseline at Week 0 Endline at Week 16;Lipid profile: total cholesterol, LDL-cholesterol, HDL-cholesterol, and triglycerides. Fatty acid analysis in blood plasmaTimepoint: Baseline at Week 0 Endline at Week 16;Anthropometry: weight, BMI, and waist circumference.Timepoint: Baseline at Week 0 Endline at Week 16;Micronutrient and antioxidant status or inflammatory markers: serum vitamin E, selected micronutrients such as iron, zinc, magnesium, hsCRP, and other inflammatory markers relevant to MASLD.Timepoint: Baseline at Week 0 Endline at Week 16;Gut microbiome and prebiotic effects: stool 16S rRNA sequencing, bacterial diversity, butyrate-producing species, and microbiota composition shifts.Timepoint: Baseline at Week 0 Endline at Week 16;Compliance to the intervention: self-reported daily consumption logs and objective verification through blood vitamin E levels.Timepoint: Baseline at Week 0 Endline at Week 16 | — |
Countries
India
Contacts
Public ContactHemant Mahajan
ICMR-National Institute of Nutrition
Outcome results
None listed