None listed
Conditions
Brief summary
To examine the effects of daily almond intake over a period of 8 weeks in overweight and obese individuals with increased risk of metabolic disease on a comprehensive array of novel markers of metabolic health that share complex interrelationships including: 1. Blood glucose regulation throughout the day/night 2. Liver fat concentration and composition 3. Abdominal (including visceral) fat volume 4. Liver function 5. Gut bacteria profile and functionality 7. Body weight and composition 8. Cardiovascular Disease Risk Markers 9. Systemic Inflammatory Markers The primary hypothesis is that daily almond consumption (56g – consumed as 2 between meal snacks) for 8 weeks will reduce diurnal PPG and GV and hepatic lipid content to a greater extent than an isocaloric control snack. Secondary hypotheses are that daily almond consumption (56g – consumed as 2 between meal snacks) for 8 weeks will improve measures of liver function, gut microbiome and permeability, systemic inflammation and traditional metabolic health markers (i.e. fasting insulin and glucose, HbA1c and lipids including cholesterol and triglyceride) to a greater extent than an isocaloric control snack.
Interventions
After a 2-week nut and seed washout period participants will consume 56g almonds/day (2 servings/day) consumed alone as whole raw almonds as a morning snack (28g) and afternoon snack (28g) for a period of 8 weeks. Participants will complete an online daily checklist throughout the study to assess compliance to the intervention.
Sponsors
Commonwealth Scientific Industrial Research Organisation
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
20 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Male or female 2. Aged 20-70 years 3. The following inclusion criteria were chosen to maximise the probability of a population with abnormal metabolic and liver function: a. Overweight/obese (BMI: >=27 kg/m2) b. Waist circumference: > 88 cm for females, >102 cm for males c. Fasting plasma glucose >=5.6 mmol/L or previously diagnosed type 2 diabetes (T2D) (confirmed by evidence of previous diagnosis and not taking any diabetes medication) 4. Weight stable (i.e. no more than 3 kg weight loss/gain in the past 2 months)
Exclusion criteria
1. Smoking 2. Usage of medications/supplements, health conditions (including gastrointestinal disease, kidney disease, liver disease, cardiovascular disease, type 1 diabetes and cancer) and lifestyle factors that may affect the study outcomes or participant’s health at the discretion of the overseeing research physician after review the screening questionnaire. 3. Have type 2 diabetes and currently taking oral hypoglycaemic or insulin medication or have uncontrolled diabetes (indicated by HbA1c >10%) 4. Body weight >~140 kg due to technical difficulties related to the measurement and analysis of MRI scans with participants >~140 kg 5. History of smoking during 6 month prior to the study 6. Known allergies to nuts, dairy, gluten or not willing to consume, test foods 7. History of heavy alcohol consumption (>4 standard drinks/day) 8. Women who are attempting to become pregnant, pregnant, lactating 9. Extended absences due to travel or other commitments 10. On any weight loss program, commercial or self-administered with the goal to lose weight 11. Past history of claustrophobia – to enable body composition assessments to be performed 12. Presence of any ferrous metal in the body - to enable body composition assessments to be performed.
Outcome results
None listed