Ignite Creation Date:
2025-12-25 @ 12:14 AM
Ignite Modification Date:
2025-12-25 @ 10:16 PM
Study NCT ID:
NCT05577858
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-02-17
First Post:
2022-10-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Protein-Distinct Macronutrient-Equivalent Diet 1
Sponsor:
South Dakota State University
Organization:
Study Overview
Official Title:
Effect of a Pulse-based USDA-diet on Gut Microbial Metabolites and Biomarkers of Healthspan: A 18-week Randomized Controlled Crossover Feeding Study in Older Adults
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-02
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:
PRODMED1
Brief Summary:
Plant-based diets are naturally low in Methionine (Met), and also low in precursor molecules (e.g L-carnitine, choline, betaine, etc.) producing microbiota-mediated proatherogenic TMAO. Among plant proteins, pulses are rich in micronutrients, and dietary fibers, making them ideal for microbiome-stimulating, nutrient-dense, healthful dietary patterns. However, daily pulse intake remains low at 8% in America despite recommendations by DGA, a resource to guide health promotion across communities. A significant body of preclinical data, waiting to be translated to humans, suggests that dietary Met restriction can trigger beneficial metabolic and anti-inflammatory adaptations leading to improved chronic health and longevity. The central hypothesis is that a pulse-protein-based healthy diet can be simultaneously equivalent to omnivorous diets in protein content and yet naturally lower in Met and TMAO to improve glycemic control, body composition, and immunometabolic flexibility to reduce the risk of chronic diseases and improve healthspan. The goal is to systematically elucidate for the first time the effects of a lacto-vegetarian feeding pattern with pulses as the primary protein source on a comprehensive panel of \~500 traditional and next-generation biomarkers of health, and assess the role of the gut microbiota in mediating such effects. We also aim to interrogate the potential concern about the lower bioavailability of non-heme iron from pulses.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
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?: