Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 3:48 AM
Ignite Modification Date:
2025-12-25 @ 3:48 AM
NCT ID:
NCT03419702
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.
Study:
NCT03419702
Study Brief:
Protocol Section:
NCT03419702