NCT02907684

The Impact of Almond Nut Consumption on Markers of CVD & Metabolic Health

A Randomised, Controlled Parallel Dietary Intervention to Investigate the Effect of Almond Snack Consumption on Cardio-metabolic Disease Risk Markers Compared With Isocaloric Snacks, in Adults at Moderate Risk of Cardiovascular Disease

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 108 (actual)
• Sponsor: King's College London · Academic / Other
• Sex: All
• Age: 30 Years – 70 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to investigate the cardio-metabolic health effects of consuming almond nuts in place of habitual (usual) snack products in adults at moderate risk of developing cardiovascular disease

Detailed description

Tree nuts are recommended in the prevention and management of cardiovascular disease (CVD) largely based on their LDL (low density lipoprotein) lowering effects, but the CVD risk reduction observed with tree nut consumption is greater than that predicted by their hypocholesterolemic effects alone. Other health benefits have also been noted by our group, such as moderation of postprandial lipemia , as well as by others such as modified postprandial glycemia , decreased blood pressure (BP) , improvement in oxidant status and weight loss. Robust evidence for the protective cardio-metabolic effects of nuts from the PREDIMED study has highlighted the association between nut consumption and decreased risk of cardiovascular events, obesity, metabolic syndrome and type 2 diabetes (T2DM). However, there is a paucity of evidence on the effects of almonds on vascular function in humans (BP and endothelium-dependent vasodilation (EDV)), although there is evidence that almonds promote nitric oxide (NO) release in animals consuming high-fat diets. Fundamental to vascular health is a well-functioning liver and there is increasing evidence to demonstrate that the accumulation of liver fat is a causative factor in the development of cardio-metabolic disorders. Non-alcoholic fatty liver disease (NAFLD) is now considered the hepatic manifestation of the metabolic syndrome (MetS); recent data has shown that it is linked to increased CVD risk via direct effects on vascular function (and EDV) independently of obesity and MetS . NAFLD is thought to affect 30% of the population in developed countries, and up to two-thirds of people with obesity and 50% of people with hyperlipidemia. Development of fatty liver, mainly attributable to obesity and elevated postprandial lipemia, is associated with increased inflammation, oxidative stress, insulin resistance, dyslipidemia and impaired EDV, and predicts risk of CVD and T2DM . Therefore, the long-term goal of this research is to understand the mechanisms underpinning how dietary change can drive favourable modification of CVD disease risk and to identify patterns in population food choices, specifically almond consumption, that tend to correlate with reduced CVD disease risk. The primary aim of this proposal is to investigate, in a randomised controlled, parallel arm, 6-wk dietary intervention (n=100) whether replacing snacks based on refined carbohydrates and poor in micronutrients/non-nutrient bioactives (NNB) with nutrient/NNB-dense, whole almond snacks can influence liver fat content (a key metabolic driver of insulin resistance and vascular dysfunction, and a hallmark of metabolic syndrome) and EDV (brachial FMD being an independent predictor of CVD events, in addition to related biomarkers of cardio-metabolic disease risk. The snacks products provide participants with 20% of their energy requirements via either whole almonds or as muffins/crackers that have been designed to mimic the average UK snack.

Conditions

• Cardiovascular Disease

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Almonds	Participants to consume almonds as snacks to contribute to 20% of their energy requirements daily for 4 weeks
DIETARY_SUPPLEMENT	Muffins/Crackers	Participants to consume muffins/crackers as snacks to contribute to 20% of their energy requirements daily for 4 weeks NB all participants will have a run in period for 2 weeks whereby muffins are consumed, this is prior to randomisation.

Timeline

• Start date: 2017-03-29
• Primary completion: 2019-05-13
• Completion: 2019-10-30
• First posted: 2016-09-20
• Last updated: 2019-12-02

Locations

1 site across 1 country: United Kingdom