GLP-1 Analogue Effects on Food Cues, Stress, Motivation for Highly Palatable Foods, and Weight

Yale University96 enrolled

Overview

To examine response to a glucagon-like peptide-1 analogue vs. placebo in patients with obesity and assess impact on craving, hunger, stress, and weight outcomes.

A randomized, double-blind, placebo-controlled 12-week study with GLP-1 analogue (semaglutide) in men and women with obesity (BMI 30-49.9 kg/m2) in a validated laboratory model to identifying processes underlying greater food craving, intake and weight change, in order to test mechanisms by which a GLP-1 analogues may exerts significant weight effects in obesity.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

QUADRUPLE

Enrollment

Conditions

Obesity

Interventions

GLP-1 analogue - semaglutideDRUG

GLP-1 analogue - semaglutide - administered once weekly for a total of 12 weeks

PlaceboOTHER

Placebo - administered once weekly for a total of 12 weeks

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 Years

Medical Language ↔ Plain English

Inclusion Criteria: * BMI ranging from 30-49.9 kg/m2 * No significant medical problems, including diabetes * No history of HgbA1c \<6.5% * English speaking and able to read English and complete study evaluations * Able to provide informed written and verbal consent Exclusion Criteria: * Any significant current medical conditions, including neurological, renal, thyroid, cardiovascular, liver, endocrine or immune conditions, including diagnosis of T2DM or T1DM by American Diabetes Association (ADA) criteria * Meet current or past DSM-IVR criteria for alcohol dependence or any substance use disorders, including nicotine, or psychiatric disorders, including eating disorders, or use of any psychiatric medications, including anxiolytics, antidepressants, naltrexone or antabuse, anti-smoking medications * Current active participation in a weight loss program or weight loss of \>10% of total body weight during the prior 6 months * Taking any other anti-obesity medication * History of pancreatitis, medullary thyroid cancer, or MEN syndrome, or (6) women who are pregnant or lactating, or peri/postmenopausal

Locations (1)

The Yale Stress Center: Yale University

New Haven, Connecticut, United States

Outcomes

Primary Outcomes

Change in Craving Score

Change in craving score will be measured using a validated and revised questionnaire called Food Craving Inventory (FCI-R). FCI-R is an 28-item questionnaire that measures how often participants experienced specific food cravings for each of 28 different food types. Participants can respond to each item from "not at all" (score=1) to "more than ever" (score=5), with total FCI-R score range of 28-140. Higher mean scores indicate greater average food craving. A negative change indicates a decrease in craving with treatment.

Time frame: Average change in avg FCI craving score from week 0 to end of treatment (week 12) computed as avg FCI score at week 12 - avg FCI score at Week 0.

Change in Hunger Score

Hunger will be measured in a Visual Analog Scale (VAS) range from 0 to 10. Higher VAS indicates greater hunger. Negative change in score indicates less hunger with treatment.

Time frame: Average change in hunger VAS rating from week 0 and end of study week 12 (week 12 VAS - Week 0 VAS)

Change in Food Intake

Food intake will be measured in total calorie energy density during a validated observed laboratory task called the Food Snack Test (FST).Negative change indicates a lower food intake with treatment.

Time frame: Change in FST total calorie energy density (totalcalED)from FST at week 0 and FST during treatment at week 12 (week 12 FST - Week 0 FST totalcalED change)

Secondary Outcomes

Change in Food Intake - Real-World

Food intake will be measured in Kcalories using 3-day 24hr recall (ASA24). A negative change indicates lower food intake with treatment.

Time frame: Average change from baseline to end of treatment (Kcalories at week 12 - week 0)

Change in Stress Score

Stress, measured as total summed score on the 14-item Perceived Stress Scale, with higher scores indicating greater subjective stress. A negative change indicates lower stress with treatment. The Perceived Stress Scale (PSS)-14 has a total score range of 0 to 56, with individual items scored from 0 ("Never") to 4 ("Very often") and positively worded items reverse-scored before summing.

Data from ClinicalTrials.gov

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