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

Primary Purpose

Muscle Weakness

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
mung bean protein
control biscuit
Sponsored by
Arizona State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Muscle Weakness focused on measuring vegetarian, vegan, plant-based, protein, strength

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Arizona State University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

mung bean

biscuit

Arm Description

daily oral administration of protein supplement

daily oral administration of control supplement

Outcomes

Primary Outcome Measures

grip strength
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
leg strength
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

lean body mass
LBM was measured via dual energy X-ray absorptiometry (DEXA) and was conducted by a trained X-ray technician.

Full Information

First Posted
August 29, 2019
Last Updated
September 3, 2019
Sponsor
Arizona State University
Collaborators
Christopher Wharton, Eric Bartholomae, April Incollingo, Maricarmen Vizcaino
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1. Study Identification

Unique Protocol Identification Number
NCT04076982
Brief Title
Effect of Supplementary Dietary Protein (21g Per Day) on Lean Mass and Strength in Sedentary, Adult Vegetarians
Acronym
MungBean
Official Title
Effect of Supplementary Dietary Protein (21g Per Day) on Lean Mass and Strength in Sedentary, Adult Vegetarians
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
September 3, 2018 (Actual)
Primary Completion Date
January 12, 2019 (Actual)
Study Completion Date
January 12, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Arizona State University
Collaborators
Christopher Wharton, Eric Bartholomae, April Incollingo, Maricarmen Vizcaino

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Muscle Weakness
Keywords
vegetarian, vegan, plant-based, protein, strength

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
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.
Allocation
Randomized
Enrollment
37 (Actual)

8. Arms, Groups, and Interventions

Arm Title
mung bean
Arm Type
Experimental
Arm Description
daily oral administration of protein supplement
Arm Title
biscuit
Arm Type
Placebo Comparator
Arm Description
daily oral administration of control supplement
Intervention Type
Dietary Supplement
Intervention Name(s)
mung bean protein
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
control biscuit
Intervention Description
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 Measure Information:
Title
grip strength
Description
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
Time Frame
change in strength from baseline to week 8
Title
leg strength
Description
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.
Time Frame
change in strength from baseline to week 8
Secondary Outcome Measure Information:
Title
lean body mass
Description
LBM was measured via dual energy X-ray absorptiometry (DEXA) and was conducted by a trained X-ray technician.
Time Frame
change in LBM from baseline to week 8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Facility Information:
Facility Name
Arizona State University
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85004
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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