Effect of Gut-Cued Eating on BMI and Efficacy of Open-Label Placebo to Augment Weight Loss

Obesity Clinical Trial

— GCE  

Official title:

Effect of Gut-Cued Eating on BMI and Efficacy of Open-Label Placebo to Augment Weight Loss

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03850990
• Other study ID #: IRB-300000000
• Status: Completed
• Phase: N/A
• Start date: September 25, 2019
• Est. completion date: May 30, 2020

Study information

• Verified date: June 2021
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study will assess the effect of attending to stomach-cues of hunger and fullness on body weight and any additional benefit provided by open-label placebo.

Description:

Students and employees from the University of Alabama at Birmingham will consent to four lab visits. On the first visit, they will get measured for a BMI, complete surveys about eating and cognitive styles. They will also get their heart rate and blood pressure taken, and provide a saliva sample for saliva quantification with dental cotton rolls in the mouth before and after a food-craving task (rating computer photos of various foods for liking and desire). They will then see a video explaining the difference between mouth and stomach hunger and instructing them to use a hunger meter to know when to start eating and when to stop eating. They will have a chance to ask questions and will receive a hard copy of the video. They will also receive a satiety tips sheet and will give permission to receive and start receiving daily motivational text messages for the next 2 weeks.

At this time all participants will also watch a short video about placebos and the effect that open-label placebos (non-deceptive placebos; the person knows they are receiving a placebo) have had on previous studies unrelated to obesity or weight loss. If randomized to the placebo group they will take 2 capsules of micro-crystalline cellulose, a non-bioactive ingredient, every day for the duration of the study. Those in the no placebo group will not receive the pills.

The second visit will take place 2 weeks after the first visit. They will be measured for another BMI, complete a meal patterns questionnaire, and have a progress interview about their experience with the new eating instructions. They will receive answers and suggestions corresponding to their interview responses on any challenges faced. Those in the placebo group will have a chance to have any questions or concerns addressed. All participants will then be scheduled for their next visit and will receive the text messages twice a week for the next 3 weeks.

The third visit will take place 3 weeks after the second visit. They will be measured again for a BMI, complete another meal patterns questionnaire, have another progress interview, and get scheduled for their last visit. No text messages will go out between this and the fourth visit.

The fourth visit will take place 3 weeks after the third visit. They will be measured for a BMI and complete another meal patterns questionnaire. They will also get another heart rate, blood pressure, and saliva quantification reading before and after the food-craving task as in the first visit. They will have a final progress interview, followed by a debriefing meeting to let them know more about the study and answer any questions related to any part of the study. They will then be asked if they want to know more about their survey and questionnaire scores. Those in the no placebo group who wish to take placebos will grant permission to be contacted for any future studies that include a placebo group.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: May 30, 2020
• Est. primary completion date: May 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Desire to lose weight

• 18-60 years of age

• Student of employee at the University of Alabama at Birmingham

Exclusion Criteria:

• Current enrollment in commercial weight loss program

• Uncontrolled diabetes

• Uncontrolled hypertension

• Current bipolar disorder

• Current or history of eating disorder

Related Conditions & MeSH terms

• Body Weight
• Eating Behavior
• Hunger
• Obesity
• Weight Loss

Intervention

Behavioral:
• Placebo pill and no placebo pill
The placebo pills will be green and white gelatin capsules containing microcrystalline cellulose and other inert ingredients.

Locations

Country	Name	City	State
United States	323 Campbell Hall	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	BMI	Change in body mass index over 8 weeks on the protocol.	8 weeks