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Effect of Supplementary Dietary Protein (21g Per Day) on Lean Mass and Strength in Sedentary, Adult Vegetarians (MungBean)

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ClinicalTrials.gov Identifier: NCT04076982
Recruitment Status : Completed
First Posted : September 4, 2019
Last Update Posted : September 4, 2019
Sponsor:
Collaborators:
Christopher Wharton
Eric Bartholomae
April Incollingo
Maricarmen Vizcaino
Information provided by (Responsible Party):
Carol Johnston, Arizona State University

Brief Summary:
It is possible that the lower protein intake in vegetarians and vegans may relate to a decrease in grip strength. Furthermore, there is limited research examining the effects of plant-based protein intake on strength and LBM independent of an exercise training component. The present study was designed to examine relationships between strength, protein intake, and LBM in underactive vegetarian and vegan adults, as well as the impact of protein supplementation (18 g mung bean protein daily) on these indices.

Condition or disease Intervention/treatment Phase
Muscle Weakness Dietary Supplement: mung bean protein Other: control biscuit Not Applicable

Detailed Description:
The American Dietetic Association states that based off of evidence, it is possible for a vegetarian to obtain the recommended amount of nutrients with a properly planned diet. By mixing various sources of plant proteins throughout the day, a person can obtain all the amino acids needed for growth and tissue maintenance and repair. Yet, many vegetarians struggle to eat a substantial diet, especially when it comes to protein. This is because plant protein has protein bioavailability that is 10-30% lower than animal protein. As a result, current research suggests that there needs to be a separate protein dietary reference intake (DRI) for vegetarians and it needs to be larger than the protein DRI for omnivores. Whenever considering protein bioavailability, the quality must be assessed by analyzing the digestibility, chemical integrity, and freedom from interference in metabolism of the amino acid. This is a major concern because inadequate protein intake can affect bone health and alter muscle mass. Importantly, research has shown as a result of inadequate protein intake, vegetarians tend to have less lean body mass and less muscle strength than omnivores. Currently, all research available on this topic included strength training as a variable for increasing lean muscle mass, and no research has been reported that analyzed the impact of increased dietary protein on lean body mass without a training component. This parallel arm study will examine the effect of supplemental plant protein on strength and lean body mass in adult, non-athletic vegetarians in the Phoenix area.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Qualifying participants will be stratified and randomly assigned to one of two treatment arms: mung bean protein or control biscuit. Participants will meet with study investigators on two occasions separated by 8 weeks for assessments.
Masking: Single (Participant)
Masking Description: Participants were told that the study investigated the impact of a dietary intervention on body composition and strength. The 'egg patty' and 'biscuit' were referred to as dietary supplements.
Primary Purpose: Other
Official Title: Effect of Supplementary Dietary Protein (21g Per Day) on Lean Mass and Strength in Sedentary, Adult Vegetarians
Actual Study Start Date : September 3, 2018
Actual Primary Completion Date : January 12, 2019
Actual Study Completion Date : January 12, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: mung bean
daily oral administration of protein supplement
Dietary Supplement: mung bean protein
Participants were instructed to consume the test foods in the morning hours and to keep a record of the days the foods were consumed on a study calendar which was returned to investigators at the final visit and used to track protocol adherence.

Placebo Comparator: biscuit
daily oral administration of control supplement
Other: control biscuit
Participants were instructed to consume the test foods in the morning hours and to keep a record of the days the foods were consumed on a study calendar which was returned to investigators at the final visit and used to track protocol adherence.




Primary Outcome Measures :
  1. grip strength [ Time Frame: change in strength from baseline to week 8 ]
    Dominant handgrip strength was measured in triplicate in a seated position with the elbow flexed to 90 degrees and a neutral wrist position in triplicate using a handheld dynamometer

  2. leg strength [ Time Frame: change in strength from baseline to week 8 ]
    Lower body strength was measured in the dominant leg using a multi-joint system dynamometer. Isokinetic knee flexion and extension were measured from a seated position at a resistance of 90°/sec.


Secondary Outcome Measures :
  1. lean body mass [ Time Frame: change in LBM from baseline to week 8 ]
    LBM was measured via dual energy X-ray absorptiometry (DEXA) and was conducted by a trained X-ray technician.



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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • vegetarian or vegan for at least one year
  • healthy by self-report

Exclusion Criteria:

  • supplement use such as protein powder or creatine
  • previous diagnosis of heart disease, cancer, stroke, diabetes, autoimmune disorders, or thyroid condition
  • competition in any athletic event in the past year
  • moderate to strenuous exercise exceeding 150 minutes per week
  • pregnant or planning to become pregnant.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04076982


Locations
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United States, Arizona
Arizona State University
Phoenix, Arizona, United States, 85004
Sponsors and Collaborators
Arizona State University
Christopher Wharton
Eric Bartholomae
April Incollingo
Maricarmen Vizcaino

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Responsible Party: Carol Johnston, Professor and Associate Dean, Arizona State University
ClinicalTrials.gov Identifier: NCT04076982     History of Changes
Other Study ID Numbers: MungBean00005383
First Posted: September 4, 2019    Key Record Dates
Last Update Posted: September 4, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Carol Johnston, Arizona State University:
vegetarian
vegan
plant-based
protein
strength
Additional relevant MeSH terms:
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Muscle Weakness
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Pathologic Processes
Signs and Symptoms