Differences in Eating Frequency Between Vegan and Omnivorous Diets

NCT ID: NCT02417480

Last Updated: 2019-04-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-04-30
• Study Completion Date: 2016-02-29

Brief 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. 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.

Conditions

Eating Behavior

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Vegan arm

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.

Group Type: ACTIVE_COMPARATOR

Follow habitual, usual diet

Intervention Type: BEHAVIORAL

Participants will be asked to consume their habitual, usual diet.

Omnivorous arm

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.

Group Type: EXPERIMENTAL

Vegan diet

Intervention Type: BEHAVIORAL

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 diet

Intervention Type: BEHAVIORAL

Participants will be asked to consume their habitual, usual diet.

Interventions

Vegan diet

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.

Intervention Type: BEHAVIORAL

Follow habitual, usual diet

Participants will be asked to consume their habitual, usual diet.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

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

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Clemson University

OTHER

Sponsor Role: collaborator

University of South Carolina

OTHER

Sponsor Role: lead

Responsible Party

Brie Turner-McGrievy

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Brie Turner-McGrievy

Role: PRINCIPAL_INVESTIGATOR

University of South Carolina

Locations

University of South Carolina

Columbia, South Carolina, United States

Countries

United States

Other Identifiers

1R21CA187929-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

Pro00043598

Identifier Type: -

Identifier Source: org_study_id