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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT01399177
Other study ID # 3177
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date June 2011
Est. completion date December 31, 2024

Study information

Verified date June 2023
Source The University of Tennessee, Knoxville
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of this study is to find out if there is any change in diet on food cravings and weight loss in the 12 months following bariatric surgery.


Description:

Research suggests that satiation processes in obese patients may be impaired, possibly resulting in excessive energy intake and poorer weight loss outcomes. One factor that may contribute to disruption of satiation processes and related overconsumption is dietary variety. Additionally, food cravings for restricted foods are believed to contribute to poor compliance to diets, and in controlled feeding studies, food cravings are the most frequently provided reason for poor dietary adherence. Interestingly, several investigations have found that cravings decrease when individuals follow a very-low-calorie or monotonous diet (9-11). Thus, reductions in the variety of the diet may also reduce food cravings, and assist in dietary adherence. It is also possible that the type of surgical procedure performed may influence changes in dietary variety, and consequently food cravings. To date, few studies have analyzed bariatric surgery patients' selection of foods within specific food groups and no study has examined the variety of foods consumed within food groups. Changes in food group variety which facilitate improvements in regulation of energy intake and body weight among obese individuals after behavioral weight loss may have a similar impact in patients who undergo bariatric surgery. Additionally, no studies have examined the relationship between changes in dietary variety and food cravings, and how these factors may be related to weight loss outcomes in any population. Primary Objectives: To examine by surgery type(Roux-En-Y gastric bypass [RYGB], laparoscopic adjustable gastric banding [LAGB], vertical sleeve gastrectomy [VSG]) 1. changes in dietary variety from pre- to post-bariatric surgery at 3, 6, and 12-months 2. changes in variety of high-energy-dense foods and changes in cravings of high-energy-dense foods at 3, 6, and 12 months and 3. changes in variety of high-energy-dense and low-energy-dense foods and changes in energy intake and weight loss at 3, 6, and 12 months.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 90
Est. completion date December 31, 2024
Est. primary completion date December 31, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - Age between 18 and 65 years - Bariatric surgery occurring within 3-6 months Exclusion Criteria: - Intend to move outside of the metropolitan area within the time frame of the investigation. - Are pregnant, lactating, less than 6 months post-partum, or plan to become pregnant during the time frame of the investigation.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States Healthy Eating and Activity Laboratory Knoxville Tennessee

Sponsors (1)

Lead Sponsor Collaborator
The University of Tennessee, Knoxville

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Diet 0, 3, 6, and 12 months
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