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NCT Number: NCT05577858

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-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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Healthy Lifestyle

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

South Dakota State University, Wagner Hall 416

Brookings, South Dakota, 57007, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Meat based

Other

Omnivorous diet following dietary guidelines

Pulse based

Other

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

Primary outcomes

  1. Ferritin

    Time frame: 16 weeks

    Microplate assay

  2. Concentration of TMAO in blood

    Time frame: 16 weeks

    Using LC/MS based method method

  3. Fasting blood glucose concentration in blood

    Time frame: 16 weeks

    Using Glucometer

Secondary outcomes

  1. Body weight in kilograms

    Time frame: 16 weeks

    Measurement

  2. Concentration of CRP in blood

    Time frame: 16 weeks

    Microplate assay

  3. Gut microbiota composition and diversity

    Time frame: 16 weeks

    16S rRNA gene sequencing

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

    Time frame: 16 weeks

    DEXA scan

  5. Concentration of sulfur containing amino acids in blood

    Time frame: 16 weeks

    LC/MS based method

  6. Digestible indispensable amino acid score using different amino acid concentrations

    Time frame: 16 weeks

    Using standard equation

  7. Concentration of IGF-1 in blood

    Time frame: 16 weeks

    Using Microplate assay kit

  8. Concentration of IGF-BP3 in blood

    Time frame: 16 weeks

    Using Microplate assay kit

  9. Concentration of Fasting insulin in blood

    Time frame: 16 weeks

    Using Microplate assay kit

  10. Peak heights of several complex lipids panel using metabolomics technique

    Time frame: 16 weeks

    LC/MS based assay

  11. Concentration Short-chain fatty acid panel in stool

    Time frame: 16 weeks

    using LC/MS based assay

  12. Peak heights of several Biogenic amines panel using metabolomics technique

    Time frame: 16 weeks

    using LC/MS based assay

  13. Muscle strength using Isokinetic muscle testing

    Time frame: 16 weeks

    Biodex ergometer

  14. Balance assessment using balance

    Time frame: 16 weeks

    Mechanography

  15. Grip force per kg mass

    Time frame: 16 weeks

    using Dynamometer

  16. Blood pressure in mm Hg

    Time frame: 16 weeks

    Upper arm cuff

Sponsors and collaborators

Lead sponsor

South Dakota State University

Other

Registry information

Official study title

Effect of a Pulse-based USDA-diet on Gut Microbial Metabolites and Biomarkers of Healthspan: A 18-week Randomized Controlled Crossover Feeding Study in Older Adults

Acronym: PRODMED1

Important dates

Study start
2022
Primary completion
2023
Study completion
2025
First posted
Oct 13, 2022
Registry last updated
Feb 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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