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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: Active NA study of Healthy Lifestyle, sponsored by South Dakota State University.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Microplate assay
Conditions Studied
Interventions
- OTHER Meat based
- OTHER Pulse based
Study Locations (1)
South Dakota
- South Dakota State University, Wagner Hall 416 - Brookings
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 76 participants |
| Start Date | 2022-11-15 |
| Est. Completion | 2025-12 |
| Phase | NA |
What the registry record for NCT05577858 still lists
NCT05577858 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 76 participants, a relatively small participant target, below the 231-participant average among 16 other Healthy Lifestyle trials with a reported enrollment target (67% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05577858's enrollment target sits among peer trials
76 9th of 16 higher than 8 of 16 other Healthy Lifestyle trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy Lifestyle trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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