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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02585102
Other study ID # GFHNRC099
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 2015
Est. completion date January 12, 2018

Study information

Verified date August 2020
Source USDA Grand Forks Human Nutrition Research Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to see if perceived barriers to vegetable consumption can be overcome by making it easier for people eat more vegetables and to see if the effects last over time.


Description:

High vegetable consumption is associated with maintenance of a healthy body weight. Americans do not eat vegetables in the amounts recommended by the dietary guidelines and interventions to increase intake have had limited results. Reported barriers to consumption include not knowing how to prepare them and being unused to eating them.To get people to eat vegetables, they have to be motivated to do so. Repeated consumption of snack foods increases overweight and obese individuals' motivation to eat snack foods. The investigators hypothesize that by increasing people's consumption of vegetables by making them easy to eat will increase the motivation value of vegetables. For this study the investigators propose to provide minimally-processed (cleaned, packaged) vegetables to overweight and obese individuals. The motivating value of vegetables will be measured using a computer task where people play a game to earn points towards portions of a vegetable or a neutral food (crackers). The investigators will determine potential moderators of the increase in the motivating value of vegetables such as genetics (single nucleotide polymorphisms) that are associated with the motivating value of food and whether people substitute eating vegetables for other foods. The investigators will also determine changes in adiposity as a result of vegetable consumption. Lastly, the investigators will determine if repeated consumption increases psychosocial predictors of vegetable intake, such as self-efficacy of eating vegetables.


Recruitment information / eligibility

Status Completed
Enrollment 102
Est. completion date January 12, 2018
Est. primary completion date January 12, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- BMI = 25 kg/m2

- Currently eating = 1 cup of vegetables (apart from fried potatoes) per day

- Willing to consent to study conditions

Exclusion Criteria:

- BMI < 25 kg/m2

- Age < 18 years or > 65 years

- Currently dieting or following specific diet

- Allergies or unwillingness to consume study foods

- Gastrointestinal disorder or disease

- Pregnant, lactating, or planning pregnancy

- Current smoker or tobacco user

- High dietary restraint or certain eating patterns

- Inability to give consent

- Medications that would influence appetite, weight gain, or weight loss

- Exclusionary medications: Didrex, Tenuate, Belviq, Contrave, Phendimetrazine, Adipex-P, Suprenza, Xenical, Qsymia, Saxenda

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Recommended Vegetable Intake
Subjects will consume vegetables in amounts recommended by the Dietary Guidelines for Americans
Usual Vegetable Intake
Subjects will consume vegetables in their usual amount

Locations

Country Name City State
United States USDA Grand Forks Human Nutrition Research Center Grand Forks North Dakota

Sponsors (3)

Lead Sponsor Collaborator
USDA Grand Forks Human Nutrition Research Center University at Buffalo, USDA, Western Human Nutrition Research Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in relative reinforcing value (RRV) of vegetables as assessed by indicator RRV of vegetables will be assessed by evaluating the number of responses (mouse button presses) a participant is willing to complete to gain access to a vegetable or an alternative snack food. 0, 4, 8, 12, 16 weeks
Secondary Change in happiness in response to eating vegetables Happiness will be assessed using a validated questionnaire, the "4-item Subjective Happiness Scale," a 7 point Likert scale with 1=not a very happy person to 7=a very happy person, before and after consuming Dietary Guidelines for Americans (DGA) recommended amounts of vegetables. 0, 8 weeks
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