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NCT05577858 · ClinicalTrials.gov registry record · NA

Protein-Distinct Macronutrient-Equivalent Diet 1

A NA study of Healthy Lifestyle, sponsored by South Dakota State University.

Active
Registry status
NA
Development phase
76
Enrollment target
1
Study location

NCT05577858 is a NA study of Healthy Lifestyle that is active but no longer recruiting, run by South Dakota State University. The registered enrollment target is 76 participants, below the 231-participant average among 16 other Healthy Lifestyle trials with a reported enrollment target (67% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT05577858, a NA study of Healthy Lifestyle, is active but no longer recruiting, sponsored by South Dakota State University.

ACTIVE NOT RECRUITING
Registry status
NA
Development phase
76 participants
Enrollment target
1
Study location

Study 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.

Conditions Studied

Interventions

  • OTHER Meat based
  • OTHER Pulse based

Study Locations (1)

South Dakota

  • South Dakota State University, Wagner Hall 416 - Brookings

Trial Details

FieldValue
Enrollment Target 76 participants
Start Date 2022-11-15
Est. Completion 2025-12
Phase NA

Sponsor

South Dakota State University

11 total trials

What the Registry Record Tells You About NCT05577858

The ClinicalTrials.gov registry entry for NCT05577858 describes a study currently listed as active not recruiting, categorized as NA. The registered enrollment target is 76 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 231-participant average among 16 other Healthy Lifestyle trials with a reported enrollment target (67% lower). The listed sponsor is South Dakota State University, which has 11 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Healthy Lifestyle appearing as the primary indexed condition, and to 2 interventions - of which Meat based is the first listed.

NCT05577858 reports 1 study location spanning 1 distinct geographic area - top geographies include South Dakota.

Frequently Asked Questions

What is clinical trial NCT05577858 about?

NCT05577858 is a clinical study titled "Protein-Distinct Macronutrient-Equivalent Diet 1". 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-stim...

What is the current status of trial NCT05577858?

This trial is currently active not recruiting. It is a NA study. The enrollment target is 76 participants. The study started on 2022-11-15. Estimated completion is 2025-12.

What conditions does trial NCT05577858 study?

This clinical trial studies the following conditions: Healthy Lifestyle.

What interventions are being tested in trial NCT05577858?

The interventions under investigation include: Meat based (OTHER), Pulse based (OTHER).

Who is sponsoring clinical trial NCT05577858?

This trial is sponsored by South Dakota State University, which has 11 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05577858 being conducted?

This trial has 1 study location across South Dakota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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