Effect of almond consumption on metabolic and liver function in overweight and obese adults with increased fasting glucose.

Not Applicable

Completed

• Conditions: Impaired glucose tolerance; cardio-metabolic disease; Metabolic and Endocrine - Diabetes; Non-alcoholic fatty liver disease; Overweight/obesity; Diet and Nutrition - Obesity; Metabolic and Endocrine - Metabolic disorders

• Registration Number: ACTRN12616000571471
• Lead Sponsor: Commonwealth Scientific Industrial Research Organisation

Brief Summary

This study showed that twice daily consumption of almond snacks (i.e. total of 56 g/day) compared with a sweet biscuit snack, was well accepted over a period of 8 weeks. Consumption of both snack types did not substantially or deferentially alter glucose variability, liver fat or liver function (as serum aminostransferases), gut permeability, systemic inflammation, or any of the traditional metabolic health markers. Serum TC/HDL-C ratio was modestly improved in women, but not in men; but as this sub-analysis was not defined a priori the results should be interpreted with some caution. Positive effects on several species of faecal microbiota were observed following almond snacks which may have important implications for improving the gut health of individuals at risk and with established type 2 diabetes. These bacterial taxa have been widely associated with the fermentation of complex carbohydrates to produce potentially beneficial metabolites. Further research in this area should focus on the functional characteristics of these microbes, and the extent to which the long-term inclusion of selective foodstuffs, such as almonds, in the diet can result in a stable increase in their prevalence. More importantly, future research should also investigate how the changes in microbes are associated with changes in cardio-metabolic health outcomes that may develop when individuals improve their overall diet quality over a longer period of time.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-05-03
• Study Completion: 2017-05-16
• Last Update Posted: 3 February 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 95

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Dynamic glucose regulation assessed by diurnal glucose variability (GV) and postprandial hyperglycaemia (PPG) from diurnal glucose profiles with data collected using a continuous glucose monitoring device worn for 7-days. [Baseline (after 2 week nut and seed washout period), 8 weeks post commencement of intervention];Liver lipid composition by proton magnetic resonance spectroscopy. [Baseline (after 2 week nut and seed washout period), 8 weeks post commencement of intervention]