CClinicalTrials.gg
CompletedNCT04076982MungBeanUpdated Sep 4, 2019

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

An interventional study of mung bean protein and control biscuit in Muscle Weakness, sponsored by Arizona State University. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-09-04.

Sponsored by Arizona State University · Not applicable, Interventional, and Other

From the registry’s dates

  • Registered 11 months after the study started (first participant enrolled Sep 2018, registered Aug 2019).
Phase
Not applicable
Study type
Interventional
Enrollment
37
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Muscle Weakness

Browse trials for

Keywords

  • vegetarian
  • vegan
  • plant-based
  • protein
  • strength
03

In context

Muscle Weakness

601 studies on the registry are indexed under Muscle Weakness; 99 are open to participants now.

This study's enrollment of 37 is below the median of 46 across 444 interventional studies indexed under Muscle Weakness.

Browse Muscle Weakness studies →

Lead sponsor

Arizona State University is the lead sponsor of 234 studies on the registry; 41 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

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.
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
37 participants (actual)

Study arms

  • Experimental
    mung bean

    daily oral administration of protein supplement

    Dietary Supplement: mung bean protein

  • Placebo comparator
    biscuit

    daily oral administration of control supplement

    Other: control biscuit

Interventions

  • Dietary supplementmung 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.

  • Othercontrol 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.

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: change in strength from baseline to week 8

  2. 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.

    Time frame: change in strength from baseline to week 8

Secondary outcomes

  1. lean body mass

    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

07

Study locations

1 site
  • Arizona State University
    Phoenix, Arizona 85004, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 4, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04076982
Lead sponsor
Arizona State University
Collaborators
Christopher Wharton, Eric Bartholomae, April Incollingo, Maricarmen Vizcaino
Responsible party
Carol Johnston (Professor and Associate Dean, Arizona State University) — Principal investigator
First posted
Sep 4, 2019
Start date
Sep 3, 2018
Primary completion
Jan 12, 2019
Completion
Jan 12, 2019
Last update
Sep 4, 2019

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion