Effect of a Pulse-based USDA-diet on Healthspan

Healthy Lifestyle Clinical Trial

Official 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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05577858
• Other study ID #: IRB-2209011-EXP
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 15, 2022
• Est. completion date: December 2024

Study information

• Verified date: February 2024
• Source: South Dakota State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 to prevent muscle wasting in older adults 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. Using the investigator's published workflow related to all proposed aspects here, the goal is to systematically elucidate for the first time the effects of a lacto-vegetarian DGA 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 76
• Est. completion date: December 2024
• Est. primary completion date: December 20, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years and older

Eligibility

Inclusion Criteria:

• generally good health status based on one routine physical in the past 15 months, current health status
• normal HbA1C, weigh 110 lb or more
• Age 60 years or more, generally healthy, all races and both sexes
• generally practicing a meat-based dietary pattern, do not have any special dietary requirement, and
• willingness to comply with the study protocol, including on-site meal consumption and sample/data collection.

Exclusion Criteria:

• medication usage, probiotic, long-term antibiotic, and tobacco/drug/alcohol use
• Not on any special diet within 3 months of recruitment, and do not have any intention to lose weight.
• 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 nutritional supplements, alcohol, non-study foods, and beverage during the study period.

Related Conditions & MeSH terms

• Healthy Lifestyle

Intervention

Other:
• Meat based
Omnivorous diet following dietary guidelines
• Pulse based
Vegetarian pulse-based diet following dietary guidelines

Locations

Country	Name	City	State
United States	South Dakota State University, Wagner Hall 416	Brookings	South Dakota

Sponsors (1)

Lead Sponsor	Collaborator
South Dakota State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Concentration of TMAO in blood	Using LC/MS based method method	16 weeks
Primary	Fasting blood glucose concentration in blood	Using Glucometer	16 weeks
Primary	Frequency of sit/stand using Chair rise test	Functional assessment	16 weeks
Secondary	Concentration of sulfur containing amino acids in blood	LC/MS based method	16 weeks
Secondary	Digestible indispensable amino acid score using different amino acid concentrations	Using standard equation	16 weeks
Secondary	Concentration of IGF-1 in blood	Using Microplate assay kit	16 weeks
Secondary	Concentration of IGF-BP3 in blood	Using Microplate assay kit	16 weeks
Secondary	Concentration of Fasting insulin in blood	Using Microplate assay kit	16 weeks
Secondary	HOMA-IR index using insulin and glucose concentration in blood	Standard equation	16 weeks
Secondary	Peak heights of several complex lipids panel using metabolomics technique	LC/MS based assay	16 weeks
Secondary	Concentration Short-chain fatty acid panel in stool	using LC/MS based assay	16 weeks
Secondary	Peak heights of several Biogenic amines panel using metabolomics technique	using LC/MS based assay	16 weeks
Secondary	Gut microbiota composition and diversity	16S rRNA gene sequencing	16 weeks
Secondary	Concentration of IL-6 in blood	Microplate assay	16 weeks
Secondary	Concentration of HsCRP in blood	Microplate assay	16 weeks
Secondary	Vascular age score, calculated using lipid markers in blood	Standard equation	16 weeks
Secondary	Body weight in kilograms	Measurement	16 weeks
Secondary	Fat and lean mass in kg using DXA for body composition measures	DEXA scan	16 weeks
Secondary	Muscle strength using Isokinetic muscle testing	Biodex ergometer	16 weeks
Secondary	Balance assessment using balance and gait score	Mechanography	16 weeks
Secondary	Grip force per kg mass	using Dynamometer	16 weeks
Secondary	Heart rate (beats per minute)	Upper arm cuff	16 weeks
Secondary	Blood pressure in mm Hg	Upper arm cuff	16 weeks