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

NCT04076982 | Completed

• 1 other identifier: MungBean00005383
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

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.

Conditions

Muscle Weakness

Keywords

vegetarian; vegan; plant-based; protein; strength

Outcome Measures

Primary Outcomes (2)

• 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

  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.

  change in strength from baseline to week 8

Secondary Outcomes (1)

• lean body mass

  change in LBM from baseline to week 8

Study Arms (2)

mung bean

EXPERIMENTAL

daily oral administration of protein supplement

Dietary Supplement: mung bean protein

biscuit

PLACEBO COMPARATOR

daily oral administration of control supplement

Other: control biscuit

Interventions

mung bean protein 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.

mung bean

control biscuit 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.

biscuit

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Arizona State University: lead
• Christopher Wharton: collaborator
• Eric Bartholomae: collaborator
• April Incollingo: collaborator
• Maricarmen Vizcaino: collaborator

Study Sites (1)

Arizona State University

Phoenix, Arizona, 85004, United States

Location

MeSH Terms

Conditions

Muscle Weakness

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Associate Dean

Model Details: 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.

Study Record Dates

• First Submitted: August 29, 2019
• First Posted: September 4, 2019
• Study Start: September 3, 2018
• Primary Completion: January 12, 2019
• Study Completion: January 12, 2019
• Last Updated: September 4, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)