Muscle WeaknessMungBeanNCT04076982
Effect of Supplementary Dietary Protein (21g Per Day) on Lean Mass and Strength in Sedentary, Adult Vegetarians
A study testing mung bean protein in people with Muscle Weakness, run by Arizona State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Muscle Weakness
- What is being tested?
- mung bean protein
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 37 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Sep 2018to 12 Jan 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- vegetarian or vegan for at least one year
- healthy by self-report
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Muscle Weakness
- Being tested
- mung bean protein, control biscuit
- Keywords
- vegetarian, vegan, plant-based, protein, strength
- Medical subject headings
- Muscle Weakness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mung bean proteinDietary supplement
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.
control biscuitOther
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.
| Study group | Role | What they receive |
|---|---|---|
| mung bean | Experimental | daily oral administration of protein supplement Receives: Dietary Supplement: mung bean protein |
| biscuit | Placebo comparator | daily oral administration of control supplement Receives: Other: control biscuit |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: change in strength from baseline to week 8
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.
Measured: 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.
Measured: change in LBM from baseline to week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2019
- Study start3 Sep 2018
- Primary completion12 Jan 2019
- Study completion12 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle WeaknessStudies of the same condition, open and under way.
- More trials run by Arizona State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arizona State University
- Sponsor type
- University, hospital or other
- Collaborators
- Christopher Wharton, Eric Bartholomae, April Incollingo, Maricarmen Vizcaino
- Responsible party
- Principal investigator, Carol Johnston, Arizona State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04076982
- Sponsor's protocol ID
- MungBean00005383
- Acronym
- MungBean
- Status last verified
- Sep 2019
- First submitted
- 29 Aug 2019
- Last updated
- 4 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Supplementary Dietary Protein (21g Per Day) on Lean Mass and Strength in Sedentary, Adult Vegetarians
- ClinicalTrials.gov ID
- NCT04076982
- Acronym / sponsor ID
- MungBean / MungBean00005383
- Conditions
- Muscle Weakness
- Keywords
- vegetarian, vegan, plant-based, protein, strength
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Arizona State UniversityUniversity, hospital or other
- Collaborators
- Christopher Wharton, Eric Bartholomae, April Incollingo, Maricarmen Vizcaino
- Study start
- 3 Sep 2018 (actual)
- Primary completion
- 12 Jan 2019 (actual)
- Study completion
- 12 Jan 2019 (actual)
- First posted
- 4 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| mung bean | Experimental | Dietary Supplement: mung bean proteindaily oral administration of protein supplement |
| biscuit | Placebo comparator | Other: control biscuitdaily oral administration of control supplement |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- vegetarian or vegan for at least one year
- healthy by self-report
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mung bean proteinParticipants 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. | Dietary supplement | mung bean |
| control biscuitParticipants 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. | Other | biscuit |
Primary outcome
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
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.
1 secondary outcome
lean body mass
Time frame: change in LBM from baseline to week 8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mung bean protein in people with Muscle Weakness, run by Arizona State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
grip strength (time frame: change in strength from baseline to week 8). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2019.