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Cardiovascular DiseaseAlmondsNCT02907684

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

A study testing Almonds and Muffins/Crackers in people with Cardiovascular Disease, run by King's College London at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 30 to 70 yearsHealthy volunteers can take part
Conditions the study is for
Cardiovascular Disease
What is being tested?
Almonds and Muffins/Crackers
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
108 participants
Where
1 siteUnited Kingdom
Study dates
29 Mar 2017to 30 Oct 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 70 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 16Show fewer
  • 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.
  • The above criteria will be measured using the screening questionnaires and from physical (blood pressure, weight, height) and biochemical measurements (full lipid count, liver function test, full blood count, glucose and insulin) made during the screening visit. Participant eligibility will be assessed against the inclusion/exclusion criteria and 'fitness' to participate will be assessed and signed off by a clinician.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

  • King's College London, Diabetes and Nutritional Sciences Division

    London, SE1 9NH

Other trials in United Kingdom

About this study

Official title: 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

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

Read the 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.

Being tested
Almonds, Muffins/Crackers
Keywords
Cardiovascular disease, Non alcoholic fatty liver, Diabetes, Almonds, Endothelium-dependent vasodilation, Fecal short chain fatty acids (SCFAs), Snacking
Medical subject headings
Cardiovascular Diseases, Non-alcoholic Fatty Liver Disease, Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AlmondsDietary supplement

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

  • Muffins/CrackersDietary 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.

Study groups in NCT02907684
Study groupRoleWhat they receive
AlmondsExperimentalAlmond snacks
Receives: Dietary Supplement: Almonds
Control muffins/crackersPlacebo comparatorMuffin/Cracker snacks
Receives: Dietary Supplement: Muffins/Crackers

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Endothelium-dependent vasodilation

    Measured via flow mediated dilation (FMD)

    Measured: Baseline (week 2)

  2. Endothelium-dependent vasodilation

    Measured via flow mediated dilation (FMD)

    Measured: Week 8 (after 2 week run in)

  3. 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

    Measured: Baseline (week 2)

  4. Liver fat %

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

    Measured: Week 8 (after 2 week run in)

Secondary outcomes (63)

  1. Pancreatic fat

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

    Measured: Baseline (week 2)

  2. Abdominal fat

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

    Measured: Baseline (week 2)

  3. Muscle fat

    Single measurement via body MRI. Only a subset of 48 participants with aim of 20 per each arm to complete.Muscle fat will be measured in the soleus muscle in the lower calf.

    Measured: Baseline (week 2)

  4. Pancreatic fat

    Single measurement via body MRI. Only a subset of 48 participants with aim of 20 per each arm to complete.

    Measured: Week 8 (after 2 week run in)

  5. Abdominal fat

    Single measurement via body MRI. Only a subset of 48 participants with aim of 20 per each arm to complete.

    Measured: Week 8 (after 2 week run in)

  6. Muscle fat

    Single measurement via body MRI. Only a subset of 48 participants with aim of 20 per each arm to complete. Muscle fat will be measured in the soleus muscle in the lower calf.

    Measured: Week 8 (after 2 week run in)

  7. Body composition: body weight

    Using Tanita scales

    Measured: Week 0, prior to 2 week run in

  8. Body composition: body weight

    Using Tanita scales

    Measured: Week 2 'Baseline'

  9. Body composition: body weight

    Using Tanita scales

    Measured: Week 4

  10. Body composition: body weight

    Using Tanita scales

    Measured: Week 6

  11. Body composition: body weight

    Using Tanita scales

    Measured: Week 8

  12. Body composition: body mass index

    Measured: Week 0, prior to 2 week run in

  13. Body composition: body mass index

    Measured: Week 2 'baseline'

  14. Body composition: body mass index

    Measured: Week 4

  15. Body composition: body mass index

    Measured: Week 6

  16. Body composition: body mass index

    Measured: Week 8

  17. Body composition: Waist circumference

    Measured: Week 0, prior to 2 week run in

  18. Body composition: Waist circumference

    Measured: Week 2 'baseline'

  19. Body composition: Waist circumference

    Measured: Week 4

  20. Body composition: Waist circumference

    Measured: Week 6

  21. Body composition: Waist circumference

    Measured: Week 8

  22. Body composition: Hip circumference

    Measured: Week 0 (prior to 2 week run in)

  23. Body composition: Hip circumference

    Measured: Week 2 'baseline'

  24. Body composition: Hip circumference

    Measured: Week 4

  25. Body composition: Hip circumference

    Measured: Week 6

  26. Body composition: Hip circumference

    Measured: Week 8

  27. Blood pressure

    Measured: Week 0 (prior to 2 week run in)

  28. Blood pressure

    Measured: Week 2 'baseline'

  29. Blood pressure

    Measured: Week 4

  30. Blood pressure

    Measured: Week 6

  31. Blood pressure

    Measured: Week 8

  32. 24 hour ambulatory blood pressure

    Measured: Week 2 'Baseline

  33. 24 hour ambulatory blood pressure

    Measured: Week 8

  34. 24 hour heart rate variability

    Measured: Week 2 'baseline'

  35. 24 hour heart rate variability

    Measured: Week 8

  36. Fecal short chain fatty acids

    Subset of participants, n=30

    Measured: Week 2 'baseline

  37. Fecal short chain fatty acids

    Subset of participants, n=30

    Measured: Week 8

  38. Gut microbiota

    Subset of participants, n=30

    Measured: Week 2 'baseline'

  39. Gut microbiota

    Subset of participants, n=30

    Measured: Week 8

  40. Fasting insulin

    Measured: week 2 'baseline'

  41. Fasting insulin

    Measured: week 8

  42. Fasting glucose

    Measured: Week 2 'baseline'

  43. Fasting glucose

    Measured: Week 8

  44. Fasting non esterified fatty acids (NEFA)

    Measured: Week 2 'baseline'

  45. Fasting non esterified fatty acids (NEFA)

    Measured: Week 8

  46. Plasma Total cholesterol

    Fasting

    Measured: Week 2 'baseline

  47. Plasma Total cholesterol

    Fasting

    Measured: Week 8

  48. Plasma LDL cholesterol

    Fasting

    Measured: Week 2 'Baseline'

  49. Plasma LDL cholesterol

    Fasting

    Measured: Week 8

  50. Plasma HDL cholesterol

    Fasting

    Measured: Week 2 'Baseline'

  51. Plasma HDL cholesterol

    Fasting

    Measured: Week 8

  52. Plasma HDL:LDL ratio

    Fasting

    Measured: Week 2 'Baseline'

  53. Plasma HDL:LDL ratio

    Fasting

    Measured: Week 8

  54. Plasma triglyceride concentration

    Fasting

    Measured: Week 2 'baseline'

  55. Plasma triglyceride concentration

    Fasting

    Measured: Week 8

  56. Homeostasis model assessment estimated insulin resistance (HOMA-IR)

    Fasting (calculated from insulin and glucose)

    Measured: Week 2 'Baseline'

  57. Homeostasis model assessment estimated insulin resistance (HOMA-IR)

    Fasting (calculated from insulin and glucose)

    Measured: Week 8

  58. Plasma adiponectin

    Measured: Week 2 'Baseline'

  59. Plasma adiponectin

    Measured: Week 8

  60. Plasma resistin

    Measured: Week 2 'baseline'

  61. Plasma resistin

    Measured: Week 8

  62. Plasma leptin

    Measured: Week 2 'baseline'

  63. Plasma leptin

    Measured: Week 8

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Sep 2016 (estimated)
  2. Study start29 Mar 2017
  3. Primary completion13 May 2019
  4. Study completion30 Oct 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
108 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02907684
Sponsor's protocol ID
ABC RFP-DHW001
Acronym
Almonds
Status last verified
Feb 2019
First submitted
30 Aug 2016
Last updated
2 Dec 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 32412597

Questions about this trial

What is this clinical trial studying?

A study testing Almonds and Muffins/Crackers in people with Cardiovascular Disease, run by King's College London at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Endothelium-dependent vasodilation (time frame: Baseline (week 2)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02907684, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2019.

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