Protein-Distinct Macronutrient-Equivalent Diet 1

Not Applicable

Active, not recruiting

• Conditions: Healthy Lifestyle
• Interventions: Other: Meat based; Other: Pulse based

• Registration Number: NCT05577858
• Lead Sponsor: South Dakota State University

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

Not available

Study Timeline

• Study First Submitted: 2022-10-07
• Study First Submitted QC: 2022-10-11
• Study First Posted: 2022-10-13
• Study Start: 2022-11-15
• Primary Completion: 2023-12-20
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-14
• Last Update Posted: 2025-02-17
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 76

Inclusion Criteria

• Generally good health status based on routine physical in the past 12 months, current healthy status
• Normal HbA1C, not underweight
• Age 60 years or more, all races, both sexes and all education level
• Do not have any special dietary requirements and willing to consume vegetarian diet
• Willingness to comply with the study protocol, including on-site meal consumption and sample/data collection.

Exclusion Criteria

• Probiotic, long-term antibiotic, and tobacco/drug/alcohol use
• Not on any special diet within 3 months of recruitment
• Impaired kidney functions
• Active history of cancer, diabetes, heart, liver, and kidney diseases
• Major gastrointestinal disorders in the past 3 months
• History of heart attacks or stroke
• Unable to meet in-person visit requirements for dining, picking up meals, and tests
• Any mental health condition that would affect the ability to provide written informed consent.
• If they had not had a routine health checkup during the 12 months prior to recruitment.
• If they were unwilling to abstain from taking certain nutritional supplements, alcohol, or non-study foods during the study period.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Meat based	Meat based	Animal protein-based dietary intervention
Pulse based	Pulse based	Pulse-protein-based dietary intervention

Primary Outcome Measures

Name	Time	Method
Ferritin	16 weeks	Microplate assay
Concentration of TMAO in blood	16 weeks	Using LC/MS based method method
Fasting blood glucose concentration in blood	16 weeks	Using Glucometer

Secondary Outcome Measures

Name	Time	Method
Body weight in kilograms	16 weeks	Measurement
Concentration of CRP in blood	16 weeks	Microplate assay
Gut microbiota composition and diversity	16 weeks	16S rRNA gene sequencing
Fat and lean mass in kg using DXA for body composition measures	16 weeks	DEXA scan
Concentration of sulfur containing amino acids in blood	16 weeks	LC/MS based method
Digestible indispensable amino acid score using different amino acid concentrations	16 weeks	Using standard equation
Concentration of IGF-1 in blood	16 weeks	Using Microplate assay kit
Concentration of IGF-BP3 in blood	16 weeks	Using Microplate assay kit
Concentration of Fasting insulin in blood	16 weeks	Using Microplate assay kit
Peak heights of several complex lipids panel using metabolomics technique	16 weeks	LC/MS based assay
Concentration Short-chain fatty acid panel in stool	16 weeks	using LC/MS based assay
Peak heights of several Biogenic amines panel using metabolomics technique	16 weeks	using LC/MS based assay
Muscle strength using Isokinetic muscle testing	16 weeks	Biodex ergometer
Balance assessment using balance	16 weeks	Mechanography
Grip force per kg mass	16 weeks	using Dynamometer
Blood pressure in mm Hg	16 weeks	Upper arm cuff

Trial Locations

Locations (1)

South Dakota State University, Wagner Hall 416; 🇺🇸 Brookings, South Dakota, United States