An interventional study of Meat based and Pulse based in Healthy Lifestyle, sponsored by South Dakota State University. Completed at 1 site in United States. Open to participants aged 60 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-17.
Sponsored by South Dakota State University · Not applicable, Interventional, and Treatment
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.
South Dakota State University is the lead sponsor of 16 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Animal protein-based dietary intervention
Other: Meat based
Pulse-protein-based dietary intervention
Other: Pulse based
Omnivorous diet following dietary guidelines
Lacto-ovo-vegetarian pulse-based diet following dietary guidelines
Ferritin
Microplate assay
Time frame: 16 weeks
Concentration of TMAO in blood
Using LC/MS based method method
Time frame: 16 weeks
Fasting blood glucose concentration in blood
Using Glucometer
Time frame: 16 weeks
Body weight in kilograms
Measurement
Time frame: 16 weeks
Concentration of CRP in blood
Microplate assay
Time frame: 16 weeks
Gut microbiota composition and diversity
16S rRNA gene sequencing
Time frame: 16 weeks
Fat and lean mass in kg using DXA for body composition measures
DEXA scan
Time frame: 16 weeks
Concentration of sulfur containing amino acids in blood
LC/MS based method
Time frame: 16 weeks
Digestible indispensable amino acid score using different amino acid concentrations
Using standard equation
Time frame: 16 weeks
Concentration of IGF-1 in blood
Using Microplate assay kit
Time frame: 16 weeks
Concentration of IGF-BP3 in blood
Using Microplate assay kit
Time frame: 16 weeks
Concentration of Fasting insulin in blood
Using Microplate assay kit
Time frame: 16 weeks
Peak heights of several complex lipids panel using metabolomics technique
LC/MS based assay
Time frame: 16 weeks
Concentration Short-chain fatty acid panel in stool
using LC/MS based assay
Time frame: 16 weeks
Peak heights of several Biogenic amines panel using metabolomics technique
using LC/MS based assay
Time frame: 16 weeks
Muscle strength using Isokinetic muscle testing
Biodex ergometer
Time frame: 16 weeks
Balance assessment using balance
Mechanography
Time frame: 16 weeks
Grip force per kg mass
using Dynamometer
Time frame: 16 weeks
Blood pressure in mm Hg
Upper arm cuff
Time frame: 16 weeks
This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
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South Dakota State University