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

NCT ID: NCT04076982

Last Updated: 2019-09-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 37 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-03
• Study Completion Date: 2019-01-12

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.

Conditions

Muscle Weakness

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

mung bean

daily oral administration of protein supplement

Group Type: EXPERIMENTAL

mung bean protein

Intervention Type: DIETARY_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.

biscuit

daily oral administration of control supplement

Group Type: PLACEBO_COMPARATOR

control biscuit

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: DIETARY_SUPPLEMENT

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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Christopher Wharton

UNKNOWN

Sponsor Role: collaborator

Eric Bartholomae

UNKNOWN

Sponsor Role: collaborator

April Incollingo

UNKNOWN

Sponsor Role: collaborator

Maricarmen Vizcaino

UNKNOWN

Sponsor Role: collaborator

Arizona State University

OTHER

Sponsor Role: lead

Responsible Party

Carol Johnston

Professor and Associate Dean

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Arizona State University

Phoenix, Arizona, United States

Countries

United States

Other Identifiers

MungBean00005383

Identifier Type: -

Identifier Source: org_study_id