Eating BehaviorVeganBytesNCT02417480
Differences in Eating Frequency Between Vegan and Omnivorous Diets
A study testing Vegan diet and Follow habitual, usual diet in people with Eating Behavior, run by University of South Carolina at 1 site in United States.
Trial summary
This study will pilot test the use of two mHealth devices. One is called the Bite Counter and one is called a MisFit. The study will be among a sample of participants (n = 50) to monitor their eating and sleeping habits. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Eating Behavior
- What is being tested?
- Vegan diet and Follow habitual, usual diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2015to Feb 2016
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants must be adults (18 years and older) that are weight stable individuals (having a BMI between 18.5 - 25
- Participants must have been following their chosen diet for at least the past 6 months
- Participants must be willing to wear a wrist-worn device to track their food intake and physical activity
Who cannot join
- Participants should have not experienced weight loss or gain ±10 lbs over the past 6 months) and they must not be on a weight loss diet
Trial locations and contacts
1 site in 1 country.
United States1 site
University of South Carolina
Columbia, South Carolina, 29208
About this study
This study will pilot test the use of two mHealth devices. One is called the Bite Counter and one is called a MisFit. The study will be among a sample of participants (n = 50) to monitor their eating and sleeping habits. The Bite Counter is a wearable watch-like device that detects and records when an individual has taken a bite of food. The benefit of using the Bite Counter is that it places a low-burden on participants to self-monitor their dietary intake. The MisFit is a commercial device that tracks an individual's sleeping and activity.
The purpose of this study is to (1) find out how the Bite Counter calculates daily bites taken on a vegan diet compared to an omnivorous diet, (2) examine differences in sleep and activity between individuals following a vegan diet compared to an omnivorous diet and (3) get feedback from users before the device is tested in larger studies.
Read the detailed description
In several randomized controlled trials comparing vegan or vegetarian diets to omnivorous dietary approaches, significant weight loss has occurred in the absence of significantly different changes in reported energy intake between groups. This is different than what is seen in studies using traditional weight loss diets (reduced energy omnivorous diets), which demonstrate a greater reduction in energy intake corresponding to greater weight loss. In observational cohort studies, among Adventist Health Study-2 participants following five different diets, BMI was found to be lowest among vegans and highest among omnivores; yet energy intake did not significantly differ among the five groups, averaging 2,000 kcals/day, with the exception of lower energy intake among semi-vegetarians.
This difference in body weight without observed differences in energy intake could possibly be explained by higher levels of physical activity among vegan and vegetarian participants, which have been observed in some of the cohort studies. Physical activity, however, was controlled for in the randomized trials either giving participants identical exercise recommendations, or holding exercise levels constant across experimental groups.
This present study will utilize the Bite Counter to estimate the differences between calories consumed between a vegan diet and an omnivore diet. The significance of using the Bite Counter is that it is a simple way to estimate energy intake. While there are many devices that measure energy expenditure (e.g. various exercise scales and equipment), there are few devices that account for energy intake. Traditional methods of estimating energy intake tend to utilize dietary recalls, but these procedures require much more effort and do not provide real time feedback like the Bite Counter does. Therefore, this study will contribute to current research by capturing data on dietary differences between vegans and omnivores, as well as assessing the usability of this device for dietary self-monitoring. The study will also use an objective physical activity and sleep tracker (the MisFit) to examine differences in exercise and sleeping between omnivorous and vegan participants.
- Conditions
- Eating Behavior
- Being tested
- Vegan diet, Follow habitual, usual diet
- Medical subject headings
- Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vegan dietBehavioural
Participants in the omnivorous arm will be asked to follow their normal diet for one week and then follow a vegan diet for one week.
Follow habitual, usual dietBehavioural
Participants will be asked to consume their habitual, usual diet.
| Study group | Role | What they receive |
|---|---|---|
| Vegan arm | Active comparator | A vegan diet is one that does not contain any animal products (no meat, fish, poultry, eggs, or dairy) but emphasizes plant-based foods, such as fruits, vegetables, whole grains, and legumes/beans. Researchers will ask participants on a vegan diet to follow their usual diet and exercise habits consistent for the two week study period. Receives: Behavioral: Follow habitual, usual diet |
| Omnivorous arm | Experimental | A diet containing all food groups. Researchers will ask participants on an omnivorous diet to follow habitual, usual diet and exercise habits for the first week. During the second week, participants will be asked to switch to a vegan diet for one week and to maintain their usual exercise habits. Receives: Behavioral: Vegan diet; Behavioral: Follow habitual, usual diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eating frequency (number of bites taken per day)
Number of bites per day will be tracked with a wearable Bite Counter
Measured: 2 weeks
Secondary outcomes (4)
Energy (kcal) intake
Energy intake will be assessed with 24-hour dietary recalls
Measured: 2 weeks
Physical activity (number of steps/day)
Number of steps per day will be assessed with a wrist-worn pedometer (MisFit).
Measured: 2 weeks
Sleep (number of hours of sleep each night)
Number of hours of sleep per night will be assessed with a wrist-word sleep tracking device (MisFit).
Measured: 2 weeks
Mood (Depression, Anxiety, and Stress Scale (DASS 21)
Stress, anxiety, and depression will be assessed with the Depression, Anxiety, and Stress Scale (DASS 21)
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2015 (estimated)
- Study startApr 2015
- Primary completionJan 2016
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eating BehaviorStudies of the same condition, open and under way.
- 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), Clemson University
- Responsible party
- Principal investigator, Brie Turner-McGrievy, University of South Carolina
- Investigators
- Brie Turner-McGrievy, Principal investigator, University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02417480
- Sponsor's protocol ID
- Pro00043598
- Other IDs
- 1R21CA187929-01A1
- Acronym
- VeganBytes
- Status last verified
- Apr 2019
- First submitted
- 8 Apr 2015
- Last updated
- 18 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Differences in Eating Frequency Between Vegan and Omnivorous Diets
- ClinicalTrials.gov ID
- NCT02417480
- Acronym / sponsor ID
- VeganBytes / Pro00043598
- Conditions
- Eating Behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- University of South CarolinaUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), Clemson University
- Study start
- Apr 2015
- Primary completion
- Jan 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 15 Apr 2015 (estimated)
- 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.
This study will pilot test the use of two mHealth devices. One is called the Bite Counter and one is called a MisFit. The study will be among a sample of participants (n = 50) to monitor their eating and sleeping habits. The Bite Counter is a wearable watch-like device that detects and records when an individual has taken a bite of food. The benefit of using the Bite Counter is that it places a low-burden on participants to self-monitor their dietary intake. The MisFit is a commercial device that tracks an individual's sleeping and activity.
The purpose of this study is to (1) find out how the Bite Counter calculates daily bites taken on a vegan diet compared to an omnivorous diet, (2) examine differences in sleep and activity between individuals following a vegan diet compared to an omnivorous diet and (3) get feedback from users before the device is tested in larger studies.
Detailed description
In several randomized controlled trials comparing vegan or vegetarian diets to omnivorous dietary approaches, significant weight loss has occurred in the absence of significantly different changes in reported energy intake between groups. This is different than what is seen in studies using traditional weight loss diets (reduced energy omnivorous diets), which demonstrate a greater reduction in energy intake corresponding to greater weight loss. In observational cohort studies, among Adventist Health Study-2 participants following five different diets, BMI was found to be lowest among vegans and highest among omnivores; yet energy intake did not significantly differ among the five groups, averaging 2,000 kcals/day, with the exception of lower energy intake among semi-vegetarians.
This difference in body weight without observed differences in energy intake could possibly be explained by higher levels of physical activity among vegan and vegetarian participants, which have been observed in some of the cohort studies. Physical activity, however, was controlled for in the randomized trials either giving participants identical exercise recommendations, or holding exercise levels constant across experimental groups.
This present study will utilize the Bite Counter to estimate the differences between calories consumed between a vegan diet and an omnivore diet. The significance of using the Bite Counter is that it is a simple way to estimate energy intake. While there are many devices that measure energy expenditure (e.g. various exercise scales and equipment), there are few devices that account for energy intake. Traditional methods of estimating energy intake tend to utilize dietary recalls, but these procedures require much more effort and do not provide real time feedback like the Bite Counter does. Therefore, this study will contribute to current research by capturing data on dietary differences between vegans and omnivores, as well as assessing the usability of this device for dietary self-monitoring. The study will also use an objective physical activity and sleep tracker (the MisFit) to examine differences in exercise and sleeping between omnivorous and vegan participants.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vegan arm | Active comparator | Behavioral: Follow habitual, usual dietA vegan diet is one that does not contain any animal products (no meat, fish, poultry, eggs, or dairy) but emphasizes plant-based foods, such as fruits, vegetables, whole grains, and legumes/beans. Researchers will ask participants on a vegan diet to follow their usual diet and exercise habits consistent for the two week study period. |
| Omnivorous arm | Experimental | Behavioral: Vegan diet, Behavioral: Follow habitual, usual dietA diet containing all food groups. Researchers will ask participants on an omnivorous diet to follow habitual, usual diet and exercise habits for the first week. During the second week, participants will be asked to switch to a vegan diet for one week and to maintain their usual exercise habits. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Participants must be adults (18 years and older) that are weight stable individuals (having a BMI between 18.5 - 25
- Participants must have been following their chosen diet for at least the past 6 months
- Participants must be willing to wear a wrist-worn device to track their food intake and physical activity
Key exclusion criteria (1 listed)
- Participants should have not experienced weight loss or gain ±10 lbs over the past 6 months) and they must not be on a weight loss diet
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 |
|---|---|---|
| Vegan dietParticipants in the omnivorous arm will be asked to follow their normal diet for one week and then follow a vegan diet for one week. | Behavioural | Omnivorous arm |
| Follow habitual, usual dietParticipants will be asked to consume their habitual, usual diet. | Behavioural | Omnivorous arm, Vegan arm |
Primary outcome
Eating frequency (number of bites taken per day)
Time frame: 2 weeks
Number of bites per day will be tracked with a wearable Bite Counter
4 secondary outcomes
Energy (kcal) intake
Time frame: 2 weeks
Physical activity (number of steps/day)
Time frame: 2 weeks
Sleep (number of hours of sleep each night)
Time frame: 2 weeks
Mood (Depression, Anxiety, and Stress Scale (DASS 21)
Time frame: 2 weeks
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 18 Apr 2019.
- Individual participant dataSharing planned: Undecided
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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.
Brie Turner-McGrievy principal investigator
University of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vegan diet and Follow habitual, usual diet in people with Eating Behavior, run by University of South Carolina 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 3 inclusion and 1 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 18 Apr 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. 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?
Eating frequency (number of bites taken per day) (time frame: 2 weeks). 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 18 Apr 2019.