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

NCT ID: NCT02907684

Last Updated: 2019-12-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 108 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-29
• Study Completion Date: 2019-10-30

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

Almonds

Almond snacks

Group Type: EXPERIMENTAL

Almonds

Intervention Type: DIETARY_SUPPLEMENT

Participants to consume almonds as snacks to contribute to 20% of their energy requirements daily for 4 weeks

Control muffins/crackers

Muffin/Cracker snacks

Group Type: PLACEBO_COMPARATOR

Muffins/Crackers

Intervention Type: DIETARY_SUPPLEMENT

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.

Interventions

Almonds

Participants to consume almonds as snacks to contribute to 20% of their energy requirements daily for 4 weeks

Intervention Type: 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.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

Subjects will be male or female, aged between 30-70 years who regularly consume ≥2 snack products a day. A principal aim is to identify and recruit subjects with increased risk of CVD, in order to increase the sensitivity of the study subjects to dietary change. Subjects who are at above average risk for developing CVD (relative risk >1.5) will be selected using a metabolic scoring system (scoring ≥2 points), adapted from the Framingham risk score system, as used previously by Chong et al. 2012. Subjects will give their own written informed consent.

Exclusion Criteria

1. Non-snack consumers (assessed as subjects consuming <2 snack products per day by a specific FFQ (food frequency questionnaire) at screening, adapted from the short Health Survey for England (2007) Eating Habits Questionnaire).

2. A reported history of myocardial infarction or cancer.

3. Being fitted with a heart pacemaker.

4. Presence of metal inside the body (implants, devices, shrapnel, metal particles in eyes from welding etc.). History of black-outs/epilepsy.

5. Diabetes mellitus (fasting plasma glucose >7 mmol/L).

6. Chronic coronary, renal or bowel disease or history of cholestatic liver disease or pancreatitis.

7. Presence of gastrointestinal disorder or use of a drug, which is likely to alter gastrointestinal motility or nutrient absorption.

8. History of substance abuse or alcoholism (past history of alcohol intake >60 units/men or 50 units/women).

9. Currently pregnant, planning pregnancy, breastfeeding or having had a baby in the last 12 months.

10. Allergy or intolerance to nuts.

11. Unwilling to follow the protocol and/or give informed consent.

12. Weight change of > 3 kg in preceding 2 months. BMI <18 kg/m2 (underweight) or >40 kg/m2 (morbidly obese due to potential technical difficulties making FMD and ambulatory blood pressure (ABP) measurements).

13. Current smokers or individuals who quit smoking within the last 6 months.

14. Participation in other research trials involving dietary or drug intervention and/ or blood collection in the past 3 months.

15. Unable or unwilling to comply with study protocol.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Almond Board of California

OTHER

Sponsor Role: collaborator

King's College London

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sarah Berry, PhD

Role: PRINCIPAL_INVESTIGATOR

King's College London

Wendy Hall, PhD

Role: PRINCIPAL_INVESTIGATOR

King's College London

Locations

King's College London, Diabetes and Nutritional Sciences Division

London, , United Kingdom

Countries

United Kingdom

References

Dikariyanto V, Smith L, Francis L, Robertson M, Kusaslan E, O'Callaghan-Latham M, Palanche C, D'Annibale M, Christodoulou D, Basty N, Whitcher B, Shuaib H, Charles-Edwards G, Chowienczyk PJ, Ellis PR, Berry SEE, Hall WL. Snacking on whole almonds for 6 weeks improves endothelial function and lowers LDL cholesterol but does not affect liver fat and other cardiometabolic risk factors in healthy adults: the ATTIS study, a randomized controlled trial. Am J Clin Nutr. 2020 Jun 1;111(6):1178-1189. doi: 10.1093/ajcn/nqaa100.

Reference Type: DERIVED

PMID: 32412597 (View on PubMed)

Other Identifiers

ABC RFP-DHW001

Identifier Type: -

Identifier Source: org_study_id