- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05577858
Effect of a Pulse-based USDA-diet on Healthspan
February 7, 2024 updated by: Moul Dey, South Dakota State University
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
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.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
76
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Moul Dey, Ph.D.
- Phone Number: 6056884050
- Email: Moul.Dey@sdstate.edu
Study Locations
-
-
South Dakota
-
Brookings, South Dakota, United States, 57007
- South Dakota State University, Wagner Hall 416
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
63 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Meat based
Animal protein-based dietary intervention
|
Omnivorous diet following dietary guidelines
|
Experimental: Pulse based
Pulse-protein-based dietary intervention
|
Vegetarian pulse-based diet following dietary guidelines
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Concentration of TMAO in blood
Time Frame: 16 weeks
|
Using LC/MS based method method
|
16 weeks
|
Fasting blood glucose concentration in blood
Time Frame: 16 weeks
|
Using Glucometer
|
16 weeks
|
Frequency of sit/stand using Chair rise test
Time Frame: 16 weeks
|
Functional assessment
|
16 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Concentration of sulfur containing amino acids in blood
Time Frame: 16 weeks
|
LC/MS based method
|
16 weeks
|
Digestible indispensable amino acid score using different amino acid concentrations
Time Frame: 16 weeks
|
Using standard equation
|
16 weeks
|
Concentration of IGF-1 in blood
Time Frame: 16 weeks
|
Using Microplate assay kit
|
16 weeks
|
Concentration of IGF-BP3 in blood
Time Frame: 16 weeks
|
Using Microplate assay kit
|
16 weeks
|
Concentration of Fasting insulin in blood
Time Frame: 16 weeks
|
Using Microplate assay kit
|
16 weeks
|
HOMA-IR index using insulin and glucose concentration in blood
Time Frame: 16 weeks
|
Standard equation
|
16 weeks
|
Peak heights of several complex lipids panel using metabolomics technique
Time Frame: 16 weeks
|
LC/MS based assay
|
16 weeks
|
Concentration Short-chain fatty acid panel in stool
Time Frame: 16 weeks
|
using LC/MS based assay
|
16 weeks
|
Peak heights of several Biogenic amines panel using metabolomics technique
Time Frame: 16 weeks
|
using LC/MS based assay
|
16 weeks
|
Gut microbiota composition and diversity
Time Frame: 16 weeks
|
16S rRNA gene sequencing
|
16 weeks
|
Concentration of IL-6 in blood
Time Frame: 16 weeks
|
Microplate assay
|
16 weeks
|
Concentration of HsCRP in blood
Time Frame: 16 weeks
|
Microplate assay
|
16 weeks
|
Vascular age score, calculated using lipid markers in blood
Time Frame: 16 weeks
|
Standard equation
|
16 weeks
|
Body weight in kilograms
Time Frame: 16 weeks
|
Measurement
|
16 weeks
|
Fat and lean mass in kg using DXA for body composition measures
Time Frame: 16 weeks
|
DEXA scan
|
16 weeks
|
Muscle strength using Isokinetic muscle testing
Time Frame: 16 weeks
|
Biodex ergometer
|
16 weeks
|
Balance assessment using balance and gait score
Time Frame: 16 weeks
|
Mechanography
|
16 weeks
|
Grip force per kg mass
Time Frame: 16 weeks
|
using Dynamometer
|
16 weeks
|
Heart rate (beats per minute)
Time Frame: 16 weeks
|
Upper arm cuff
|
16 weeks
|
Blood pressure in mm Hg
Time Frame: 16 weeks
|
Upper arm cuff
|
16 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Moul Dey, Ph.D., South Dakota State University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 15, 2022
Primary Completion (Actual)
December 20, 2023
Study Completion (Estimated)
December 1, 2024
Study Registration Dates
First Submitted
October 7, 2022
First Submitted That Met QC Criteria
October 11, 2022
First Posted (Actual)
October 13, 2022
Study Record Updates
Last Update Posted (Estimated)
February 9, 2024
Last Update Submitted That Met QC Criteria
February 7, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Other Study ID Numbers
- IRB-2209011-EXP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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