Almonds and Health Effects on Metabolism, Vascular Function and Cognition

N/ACompletedNCT03419702

Maastricht University Medical Center43 enrolled

Overview

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.

Objectives: Secondary objectives are to investigate if improved chronic glucose metabolism in subjects with impaired glucose tolerance and/or impaired fasting glucose after long-term almond consumption translates into improved peripheral and brain vascular function, and enhanced cognitive performance. In addition, the investigators will address to what extent improved chronic glucose metabolism in subjects with impaired glucose tolerance and/or impaired fasting glucose after long-term almond consumption can be explained by (combined) effects of lowered hepatic lipid accumulation and inflammation, skeletal muscle characteristics, visceral and subcutaneous fat accumulation, pancreatic function or fecal microbiota composition. Study design: The proposed study will be a 12 months randomised, controlled trial with a cross-over design. Two experimental periods of five months will be separated by a two months washout period. Study population: Forty-three impaired glucose tolerant and/or impaired fasting glucose subjects, with overweight and mild obesity (BMI 25-35 kg/m2), aged 40-70 years. Intervention: During the intervention period of 5 months, subjects will receive daily 50 gr almonds, but not in the 2 months washout and 5 months control periods.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

PreDiabetes Impaired Glucose Tolerance Impaired Fasting Glucose Overweight and Obesity

Interventions

AlmondsDIETARY_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.

Eligibility

Sex: ALLMin age: 40 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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 * No active cardiovascular disease like congestive heart failure or cardiovascular event, such as an acute myocardial infarction or cerebrovascular accident * Willingness to give up being a blood donor from 8 weeks before the start of the study, during the study and for 4 weeks after completion of the study * No difficult venipuncture as evidenced during the screening visit * Willing to comply to study protocol during study * Informed consent signed Exclusion Criteria: * 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 * Use of over-the-counter and prescribed medication or supplements, which may interfere with study measurements to be judged by the principal investigator; * Use of oral antibiotics in 40 days or less prior to the start of the study; * Blood donation in the past 3 months before the start of the study * Not willing to comply to study protocol during study or sign informed consent

Locations (1)

Maastricht University, Department of Nutrition and Movement Sciences

Maastricht, Limburg, Netherlands

Outcomes

Primary Outcomes

Insulin sensitivity

Glucose infusion rate during a hyper-insulinemic euglycemic clamp.

Time frame: Change from control period (week 22 and week 52)

Secondary Outcomes

Glucose concentrations

Fasting plasma glucose concentrations will be determined in blood samples.

Time frame: 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

Markers for fasting lipid metabolism include serum total cholesterol (mmol/L), HDL cholesterol (mmol/L), and triacylglycerol (mmol/L) concentrations.

Time frame: 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

Fasting LDL cholesterol concentrations will be determined in blood samples using the Friedewald equation.

Time frame: 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

Concentrations of CRP will be determined in blood samples.

Time frame: 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

Systolic and diastolic blood pressure.

Time frame: 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

Body weight

Data from ClinicalTrials.gov

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