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The Nuts for LIFE (Lipids, InFlammation, Endothelial) Study: The dose-response effect of hazelnut consumption on blood lipids, inflammatory markers and endothelial function in overweight and obese individuals

A 12-week randomised, parallel dietary intervention to compare the effects of consuming 30g or 60g of nuts per day, or no nuts (control) on biomarkers of chronic disease, including blood lipids, inflammation, endothelial function, and body composition in overweight and obese individuals.

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12610000285055
Enrollment
90
Registered
2010-04-09
Start date
2010-05-08
Completion date
Unknown
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Novel risk factors for heart disease have been identified, including inflammation and impaired blood vessel function. Nuts, due to their unique nutrient composition, could potentially reduce these risk factors when regularly incorporated into the diet. Current guidelines recommending the daily inclusion of 30g of nuts are largely based on their cholesterol-lowering properties. There is an absence of studies investigating optimal intakes of nuts for improvement in these novel risk factors. Therefore, the aim of the project is to compare the effects of incorporating hazelnuts at two different doses (30 g/d, 60 g/d) with a diet without nuts (control) on inflammatory markers, endothelial function, plasma lipids and lipoproteins, and body composition.

Interventions

This will be a randomised, controlled, parallel intervention trial with three arms: no nuts (control group), 30g of hazelnuts per day, 60g of hazelnuts per day. The study will be carried out to assess the effects of incorporating hazelnuts at two different doses (30 g/d, 60 g/d) with a diet without nuts on blood lipids and lipoproteins, inflammatory markers, endothelial function, body composition and oral fatty acid sensitivity in overweight and obese people. A 2-week run-in period will be used

This will be a randomised, controlled, parallel intervention trial with three arms: no nuts (control group), 30g of hazelnuts per day, 60g of hazelnuts per day. The study will be carried out to assess the effects of incorporating hazelnuts at two different doses (30 g/d, 60 g/d) with a diet without nuts on blood lipids and lipoproteins, inflammatory markers, endothelial function, body composition and oral fatty acid sensitivity in overweight and obese people. A 2-week run-in period will be used to control for baseline effects of nut intake, in which all participants will be asked to minimise nut intake and keep a nut diary. Baseline measurements will be collected from each participant after the run-in period. After collecting all the baseline measurements, each participant will be randomly allocated to one of the three groups for a period of 12 weeks.

Sponsors

University of Otago
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used)

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

The inclusion criteria are males and females aged between 18 and 65 years with a Body Mass Index (BMI) greater than or equal to 25 [weight (kg) / height (m2)]

Exclusion criteria

The exclusion criteria are smokers. Pregnant or breastfeeding women. People who have asthma. People who are on weight loss programmes. People with food allergies or food aversions to nuts. People who have inflammatory diseases such as Crohn's or Celiac disease. People who have familial or secondary hyperlipidaemia or major chronic diseases such as cancer, heart disease or diabetes. People who are taking medication known to affect inflammatory markers, e.g. aspirin, ibuprofen, naproxen, glucocorticoids, etc.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026