Almonds and Health Effects on Metabolism, Vascular Function and Cognition

NCT03419702 | Completed DMC

• 1 other identifier: METC173015
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of the proposed study is to examine and understand the impact of long-term almond consumption on chronic glucose metabolism in subjects with impaired glucose tolerance and/or impaired fasting glucose.

Conditions

PreDiabetes; Impaired Glucose Tolerance; Impaired Fasting Glucose; Overweight and Obesity

Outcome Measures

Primary Outcomes (1)

• Insulin sensitivity

  Glucose infusion rate during a hyper-insulinemic euglycemic clamp.

  Change from control period (week 22 and week 52)

Secondary Outcomes (32)

• Glucose concentrations

  Glucose will be measured at week 0, week 5, week 10, week 21, week 22, week 30, week 35, week 40, week 51, week 52

• Markers for fasting lipid metabolism

  These markers will be measured at week 0, week 5, week 10, week 21, week 22, week 30, week 35, week 40, week 51, week 52

• LDL cholesterol concentrations

  These markers will be calculated from measurements at week 0, week 5, week 10, week 21, week 22, week 30, week 35, week 40, week 51, week 52

• C-reactive protein concentrations

  CRP will be measured at week 0, week 5, week 10, week 21, week 22, week 30, week 35, week 40, week 51, week 52

• Blood pressure

  Blood pressure will be measured at week 0, week 5, week 10, week 21, week 22, week 30, week 35, week 40, week 51, week 52

Study Arms (2)

Control

NO INTERVENTION

No almonds

Experimental

EXPERIMENTAL

Almonds

Dietary Supplement: Almonds

Interventions

Almonds DIETARY_SUPPLEMENT

During the intervention period of 5 months, subjects will receive daily 50 gr almonds. Subjects are free to consume the almonds during the day whenever they want to, i.e. there will not be guidelines when to consume the almonds.

Experimental

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged between 40-70 years
• Men and women
• BMI between 25-35 kg/m2 (overweight and obese)
• Being classified as having impaired glucose tolerance (IGT) and/or impaired fasting glucose (IFG). IGT is defined according the criteria of the WHO and American Diabetes Association (ADA) as two-hour glucose concentrations of 7.8 to 11.0 mmol/l (140 to 199 mg per dL) during the 75-g oral glucose tolerance test. IFG is defined as having a fasting plasma glucose between 6.1 and 7.0 mmol/l (110 to 125 mg per dL) and a two-hour glucose concentration below 7.8 mmol/l (140 mg per dL).
• Serum total cholesterol \< 8.0 mmol/L (further testing is recommended for excessive hyperlipidemia \[serum total cholesterol ≥ 8.0 mmol/L\] according to the Standard for cardiovascular risk management of the Dutch general practitioners community \[NHG\])
• Serum triacylglycerol \< 4.52 mmol/L
• No current smoker
• No diabetic patients
• No familial hypercholesterolemia
• No abuse of drugs
• Not more than 4 alcoholic consumption per day with a maximum of 21 per week
• Stable body weight (weight gain or loss \< 3 kg in the past three months)
• No use of medication known to treat blood pressure, lipid or glucose metabolism
• No use of an investigational product within another biomedical intervention trial within the previous 1-month
• No severe medical conditions that might interfere with the study, such as epilepsy, asthma, kidney failure or renal insufficiency, chronic obstructive pulmonary disease, inflammatory bowel diseases, auto inflammatory diseases and rheumatoid arthritis

You may not qualify if:

• Allergy or intolerance to almonds
• Serum total cholesterol ≥ 8.0 mmol/L
• Serum triacylglycerol ≥ 4.52 mmol/L
• Current smoker, or smoking cessation \<12 months
• Diabetic patients
• Familial hypercholesterolemia
• Abuse of drugs
• More than 4 alcoholic consumptions per day or 21 per week
• Unstable body weight (weight gain or loss \> 3 kg in the past three months)
• Use medication known to treat blood pressure, lipid or glucose metabolism
• Use of an investigational product within another biomedical intervention trial within the previous 1-month
• Severe medical conditions that might interfere with the study, such as epilepsy, asthma, kidney failure or renal insufficiency, chronic obstructive pulmonary disease, inflammatory bowel diseases, auto inflammatory diseases and rheumatoid arthritis
• Active cardiovascular disease like congestive heart failure or cardiovascular event, such as an acute myocardial infarction or cerebrovascular accident
• Not willing to give up being a blood donor from 8 weeks before the start of the study, during the study or for 4 weeks after completion of the study
• Not or difficult to venipuncture as evidenced during the screening visit

Sponsors & Collaborators

• Maastricht University Medical Center: lead
• Almond Board of California: collaborator

Study Sites (1)

Maastricht University, Department of Nutrition and Movement Sciences

Maastricht, Limburg, 6200 MD, Netherlands

Location

Related Publications (2)

• Chavez-Alfaro MA, Mensink RP, Gravesteijn E, Joris PJ, Plat J. Effects of long-term almond consumption on markers for vascular function and cardiometabolic risk in men and women with prediabetes: results of a randomized, controlled cross-over trial. Eur J Nutr. 2024 Nov 15;64(1):7. doi: 10.1007/s00394-024-03510-y.

  PMID: 39546040 DERIVED

• Gravesteijn E, Mensink RP, Plat J. The effects of long-term almond consumption on whole-body insulin sensitivity, postprandial glucose responses, and 48 h continuous glucose concentrations in males and females with prediabetes: a randomized controlled trial. Eur J Nutr. 2023 Sep;62(6):2661-2672. doi: 10.1007/s00394-023-03178-w. Epub 2023 May 31.

  PMID: 37258943 DERIVED

MeSH Terms

Conditions

Prediabetic State; Glucose Intolerance; Overweight; Obesity

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperglycemia; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jogchum Plat, PhD

  Maastricht University

  PRINCIPAL INVESTIGATOR

• Ronald P Mensink, PhD

  Maastricht University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2018
• First Posted: February 5, 2018
• Study Start: January 10, 2018
• Primary Completion: December 3, 2021
• Study Completion: December 3, 2021
• Last Updated: March 4, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)