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

NCT02907684 | Completed

• 1 other identifier: ABC RFP-DHW001
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

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

Conditions

Cardiovascular Disease

Keywords

Cardiovascular disease; Non alcoholic fatty liver; Diabetes; Almonds; Endothelium-dependent vasodilation; Fecal short chain fatty acids (SCFAs); Snacking

Outcome Measures

Primary Outcomes (4)

• Endothelium-dependent vasodilation

  Measured via flow mediated dilation (FMD)

  Baseline (week 2)

• Endothelium-dependent vasodilation

  Measured via flow mediated dilation (FMD)

  Week 8 (after 2 week run in)

• Liver fat %

  Via MRI and magnetic resonance spectroscopy (MRS) analysis. Only a subset of 48 participants with aim of 20 per each arm to complete

  Baseline (week 2)

• Liver fat %

  Via MRI and MRS analysis. Only a subset of 48 participants with aim of 20 per each arm to complete

  Week 8 (after 2 week run in)

Secondary Outcomes (63)

• Pancreatic fat

  Baseline (week 2)

• Abdominal fat

  Baseline (week 2)

• Muscle fat

  Baseline (week 2)

• Pancreatic fat

  Week 8 (after 2 week run in)

• Abdominal fat

  Week 8 (after 2 week run in)

Other Outcomes (5)

• Adverse events

  Through study completion, average of 1.5 years.

• Snack product acceptability

  Week 6

• 4 day food diaries

  4 days at screening

Study Arms (2)

Almonds

EXPERIMENTAL

Almond snacks

Dietary Supplement: Almonds

Control muffins/crackers

PLACEBO COMPARATOR

Muffin/Cracker snacks

Dietary Supplement: Muffins/Crackers

Interventions

Almonds DIETARY_SUPPLEMENT

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

Almonds

Muffins/Crackers 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.

Control muffins/crackers

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).
• A reported history of myocardial infarction or cancer.
• Being fitted with a heart pacemaker.
• Presence of metal inside the body (implants, devices, shrapnel, metal particles in eyes from welding etc.). History of black-outs/epilepsy.
• Diabetes mellitus (fasting plasma glucose \>7 mmol/L).
• Chronic coronary, renal or bowel disease or history of cholestatic liver disease or pancreatitis.
• Presence of gastrointestinal disorder or use of a drug, which is likely to alter gastrointestinal motility or nutrient absorption.
• History of substance abuse or alcoholism (past history of alcohol intake \>60 units/men or 50 units/women).
• Currently pregnant, planning pregnancy, breastfeeding or having had a baby in the last 12 months.
• Allergy or intolerance to nuts.
• Unwilling to follow the protocol and/or give informed consent.
• 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).
• Current smokers or individuals who quit smoking within the last 6 months.
• Participation in other research trials involving dietary or drug intervention and/ or blood collection in the past 3 months.
• Unable or unwilling to comply with study protocol.

Sponsors & Collaborators

• King's College London: lead
• Almond Board of California: collaborator

Study Sites (1)

King's College London, Diabetes and Nutritional Sciences Division

London, SE1 9NH, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 32412597 DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases; Non-alcoholic Fatty Liver Disease; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Sarah Berry, PhD

  King's College London

  PRINCIPAL INVESTIGATOR

• Wendy Hall, PhD

  King's College London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 30, 2016
• First Posted: September 20, 2016
• Study Start: March 29, 2017
• Primary Completion: May 13, 2019
• Study Completion: October 30, 2019
• Last Updated: December 2, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)