Ignite Creation Date:
2025-12-25 @ 3:48 AM
Ignite Modification Date:
2026-02-20 @ 1:39 PM
Study NCT ID:
NCT03419702
Status:
COMPLETED
Last Update Posted:
2022-03-04
First Post:
2018-01-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Almonds and Health Effects on Metabolism, Vascular Function and Cognition
Sponsor:
Maastricht University Medical Center
Organization:
Study Overview
Official Title:
Effects of Almond Consumption on Chronic Glucose Regulation, Vascular Function and Cognitive Performance: The AL-INCLUSIVE Trial
Status:
COMPLETED
Status Verified Date:
2022-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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:
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: