Feasibility Study to Increase Vegetable Consumption

NCT02287441 | Completed

• 1 other identifier: IRB2014-090
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to determine if differences exist in the total vegetable intake of groups that eat either tomato products versus raw vegetable product.

Conditions

Increase Intake of Vegetables or Tomatoes; Health

Outcome Measures

Primary Outcomes (1)

• Changes in vegetable and nutrient consumption reported by subject through the 24-Hour online recall software.

  Changes will be assessed based upon MyPlate.gov serving equivalents for vegetables.

  2 weeks

Secondary Outcomes (1)

• Overall experience with increasing vegetable intake through weekly Experience Questionnaires.

  2 weeks

Study Arms (2)

Raw Group

PLACEBO COMPARATOR

Vegetables Prepared Raw (raw)

Other: Raw

Tomato Group

EXPERIMENTAL

Tomato Products (tomato)

Other: Tomato

Interventions

Tomato OTHER

Tomato Products (tomato)

Tomato Group

Raw OTHER

Vegetables Prepared Raw (raw).

Raw Group

Eligibility Criteria

• Age: 25 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Non-smoking men and women ages 25-60 years of age with BMI between 18.5-29.9
• Generally healthy as determined by health history questionnaire
• Weight stable
• Consume a typical western diet
• Access to grocery store with Hunt's tomato products and raw vegetable availability
• Have general cooking skills and kitchen equipped for general food preparation
• Primary shopper and food preparer in household
• Access to internet and ability to complete ASA24
• Past smokers will be allowed in the study if smoking cessation is \>1 year (preferred \> 2 years).

You may not qualify if:

• Smokers
• Current vegetable intake is atypical in type or amount relative to typical American diet
• Currently dieting or taking weight loss medication or weight loss supplements
• Change in weight of more than 5% in the past month
• Special or atypical diet - e.g., vegetarian/vegan, gluten free, excessively high or low energy
• Allergic to common food(s) (dairy, soy, nut/peanut, wheat, intolerance to tomatoes)
• Have fasting blood glucose concentrations \>125 mg/dL
• Had cancer other than non-melanoma skin cancer in previous 5 yrs
• Unwilling to eat vegetables
• History of eating disorder or clinical depression as assessed by validated questionnaires.
• Presence of chronic disease or condition (e.g. diabetes, irritable bowel syndrome)
• Chronic or acute gastrointestinal disorder
• Females who are pregnant or breastfeeding
• An athlete in training or highly active person whose dietary intake is greater than average
• Investigator is uncertain about subject's capability or willingness to comply with protocol requirements

Sponsors & Collaborators

• Clinical Nutrition Research Center, Illinois Institute of Technology: lead

Study Sites (1)

Clinical Nutrition Research Center

Chicago, Illinois, 60616, United States

Location

MeSH Terms

Interventions

Airway Resistance

Intervention Hierarchy (Ancestors)

Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Diagnostic Techniques and Procedures; Diagnosis; Respiratory Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Study Officials

• Britt Burton-Freeman, Ph.D

  Illinois Institute of Technology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 6, 2014
• First Posted: November 10, 2014
• Study Start: November 14, 2014
• Primary Completion: May 22, 2015
• Study Completion: April 12, 2016
• Last Updated: January 26, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)