Differences in Eating Frequency Between Vegan and Omnivorous Diets

NCT02417480 | Completed

• 2 other identifiers: Pro000435981R21CA187929-01A1
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Eating Behavior

Outcome Measures

Primary Outcomes (1)

• Eating frequency (number of bites taken per day)

  Number of bites per day will be tracked with a wearable Bite Counter

  2 weeks

Secondary Outcomes (4)

• Energy (kcal) intake

  2 weeks

• Physical activity (number of steps/day)

  2 weeks

• Sleep (number of hours of sleep each night)

  2 weeks

• Mood (Depression, Anxiety, and Stress Scale (DASS 21)

  2 weeks

Study Arms (2)

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.

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.

Behavioral: Vegan diet; Behavioral: Follow habitual, usual diet

Interventions

Vegan diet 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.

Omnivorous arm

Follow habitual, usual diet BEHAVIORAL

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

Omnivorous arm; Vegan arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of South Carolina: lead
• National Cancer Institute (NCI): collaborator
• Clemson University: collaborator

Study Sites (1)

University of South Carolina

Columbia, South Carolina, 29208, United States

Location

MeSH Terms

Conditions

Feeding Behavior

Interventions

Diet, Vegan

Condition Hierarchy (Ancestors)

Behavior, Animal; Behavior

Intervention Hierarchy (Ancestors)

Diet, Vegetarian; Diet, Plant-Based; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Brie Turner-McGrievy

  University of South Carolina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 8, 2015
• First Posted: April 15, 2015
• Study Start: April 1, 2015
• Primary Completion: January 1, 2016
• Study Completion: February 1, 2016
• Last Updated: April 18, 2019

Record last verified: 2019-04

Locations

US (1)