NCT05161897

Individualized Nutrition Therapy for Preventing or Delaying Onset of Type-2 Diabetes

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: George Mason University · Academic / Other
• Sex: All
• Age: 45 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The overall aim of this feasibility study is to conduct a randomized, controlled intervention providing adults with prediabetes either an individualized nutrition therapy (INT) intervention that contains individualized dietary goal-setting components, the goal being to improve blood glucose, reduce CVD risk factors, and therefore postpone the onset of diabetes and related cardiovascular disease, or standard-of-care generalized dietary recommendation (SOC). The hypothesis is that the INT arm will experience greater benefits in some or all of the following primary outcome variables: improvement in postprandial blood glucose, oral glucose tolerance test, fasting insulin, and calculated insulin sensitivity (HOMA) in individuals with prediabetes. Secondary outcome variables are improved markers of inflammation, antioxidant status, blood lipids, blood pressure, and endothelial function.

Conditions

• PreDiabetes
• Cardiovascular Diseases

Interventions

Type	Name	Description
OTHER	Individualized Nutrition Therapy	Explained in arm/group description.

Timeline

• Start date: 2022-08-25
• Primary completion: 2023-12-14
• Completion: 2023-12-14
• First posted: 2021-12-17
• Last updated: 2024-05-08

Locations

1 site across 1 country: United States