Protein-Distinct Macronutrient-Equivalent Diet 1

NCT05577858 | Active Not Recruiting

• 1 other identifier: IRB-2209011-EXP
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Lifestyle

Outcome Measures

Primary Outcomes (3)

• Ferritin

  Microplate assay

  16 weeks

• Concentration of TMAO in blood

  Using LC/MS based method method

  16 weeks

• Fasting blood glucose concentration in blood

  Using Glucometer

  16 weeks

Secondary Outcomes (16)

• Body weight in kilograms

  16 weeks

• Concentration of CRP in blood

  16 weeks

• Gut microbiota composition and diversity

  16 weeks

• Fat and lean mass in kg using DXA for body composition measures

  16 weeks

• Concentration of sulfur containing amino acids in blood

  16 weeks

Study Arms (2)

Meat based

OTHER

Animal protein-based dietary intervention

Other: Meat based

Pulse based

EXPERIMENTAL

Pulse-protein-based dietary intervention

Other: Pulse based

Interventions

Meat based OTHER

Omnivorous diet following dietary guidelines

Meat based

Pulse based OTHER

Lacto-ovo-vegetarian pulse-based diet following dietary guidelines

Pulse based

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• South Dakota State University: lead

Study Sites (1)

South Dakota State University, Wagner Hall 416

Brookings, South Dakota, 57007, United States

Location

Related Publications (1)

• de Vargas BO, Vaezi S, Freeling JL, Zhang Y, Weidauer L, Lee CL, Zhao J, Dey M. Design and Implementation of the Protein-Distinct Macronutrient-Equivalent Diet (PRODMED) Study: An Eighteen-Week Randomized Crossover Feeding Trial Among Free-Living Rural Older Adults. Curr Dev Nutr. 2025 Mar 24;9(5):104588. doi: 10.1016/j.cdnut.2025.104588. eCollection 2025 May.

  PMID: 40291832 DERIVED

Study Officials

• Moul Dey, Ph.D.

  South Dakota State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Blinding will be implemented to the extent possible. A researcher, unaware of the study goals and not involved with downstream data analyses will use a 1:1 block randomization to allocate participants to the diets in the first arm. Food service personnel (care provider) will not be aware of study goals and allocations. Metabolomic assays will be run in a blinded manner.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 7, 2022
• First Posted: October 13, 2022
• Study Start: November 15, 2022
• Primary Completion: December 20, 2023
• Study Completion: December 1, 2025
• Last Updated: February 17, 2025

Record last verified: 2025-02

Locations

US (1)