NCT03419702

Almonds and Health Effects on Metabolism, Vascular Function and Cognition

Effects of Almond Consumption on Chronic Glucose Regulation, Vascular Function and Cognitive Performance: The AL-INCLUSIVE Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 43 (actual)
• Sponsor: Maastricht University Medical Center · Academic / Other
• Sex: All
• Age: 40 Years – 70 Years
• Healthy volunteers: Not accepted

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: 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.

Conditions

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

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Almonds	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.

Timeline

• Start date: 2018-01-10
• Primary completion: 2021-12-03
• Completion: 2021-12-03
• First posted: 2018-02-05
• Last updated: 2022-03-04

Locations

1 site across 1 country: Netherlands