NCT03419702CompletedNot Applicable
Effects of Almond Consumption on Chronic Glucose Regulation, Vascular Function and Cognitive Performance: The AL-INCLUSIVE Trial
Maastricht University Medical Center2 sites in 1 country43 target enrollmentStarted: January 10, 2018Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 43
- Locations
- 2
- Primary Endpoint
- Insulin sensitivity
Study Overview
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.
Detailed Description
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:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 40 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Insulin sensitivity
Time Frame: Change from control period (week 22 and week 52)
Glucose infusion rate during a hyper-insulinemic euglycemic clamp.
Secondary Outcomes
- 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)
- Pulse Wave Analysis(Change from control period (week 21 and week 51))
- Pulse Wave Velocity(Change from control period (week 21 and week 51))
- Nitric oxides concentrations(Change from control period (week 21 and week 51))
- 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)
- 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)
- Markers for low-grade systemic inflammation(Change from control period (week 21 and week 51))
- Lipid oxidation(Indirect calorimetry will be performed at week 21, week 22, week 51, week 52 at several time slots.)
- Glucose oxidation(Indirect calorimetry will be performed at week 21, week 22, week 51, week 52 at several time slots.)
- Body weight(Body weight 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 circumferences(Waist and hip circumferences 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 endothelial dysfunction(Change from control period (week 21 and week 51))
- Markers for postprandial lipid metabolism(Change from control period (week 21 and week 51))
- Markers for liver function(Change from control period (week 21 and week 51))
- Cognitive performance(Cognition will be tested at week 0, week 10, week 21, week 30, week 40, week 51.)
- Markers for fasting and postprandial glucose and insulin metabolism(Change from control period (week 21 and week 51))
- Markers for nerve growth(Change from control period (week 21 and week 51))
- Markers for advanced glycation endproducts(Change from control period (week 21 and week 51))
- Microbiota composition(Change from control period (week 21 and week 51))
- 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)
- Retinal microvascular caliber(Change from control period (week 21 and week 51))
- Fat distribution in abdomen(Change from control period (week 22 and week 52))
- Biopsies adipose tissue(Change from control period (week 22 and week 52))
- Biopsies muscle tissue(Change from control period (week 22 and week 52))
- Cerebral blood flow(Change from control period (week 22 and week 52))
- Blood pressure profiles(Change from control period (week 21 and week 51))
- Physical activity profiles(Change from control period (week 21 and week 51))
- General well-being(General well-being will be tested at week 0, week 10, week 21, week 30, week 40, week 51.)
- Food frequency(Food frequency will be tested at week 0, week 10, week 21, week 30, week 40, week 51.)
- Glucose profiles(Change from control period (week 21 and week 51))
- Skinfold measurements(Change from control period (week 22 and week 52))
Investigators
Study Sites (2)
Loading locations...
Similar Trials
Completed
Not Applicable
Effects of almond consumption on chronic glucose regulation, vascular function and cognitive performance: The AL-INCLUSIVE trialdiabetesNL-OMON50723niversiteit Maastricht84
Active, not recruiting
Phase 3
Effect of Almond Consumption on Blood Glucose Regulation in prediabeticsCTRI/2018/02/011927SNDTWomens University
Terminated
Not Applicable
Almond Effects on Glucose Intolerance StudyPrediabetesNCT02260895Memorial Hermann Health System24
Completed
Not Applicable
Almond Consumption and GlycemiaGlucose IntoleranceAppetite DisordersGlucose Metabolism Disorders (Including Diabetes Mellitus)Lipid Metabolism DisorderNCT03236116Purdue University75
Completed
Not Applicable
The Effect of Whole Almonds on Biomarkers of Cardiovascular Disease in Chinese Patients With Type 2 DiabetesType 2 DiabetesNCT01656850Taipei Medical University40