Clinical trial NCT02258477: A Pilot Study: Snacking, Willpower and Glucose Availability
Official title: A Pilot Study: Snacking, Willpower and Glucose Availability
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Willpower
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: Johnson & Johnson
First posted: 2014-10-07
Enrollment: 37
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: To compare the effects of ingesting 100, 50 and 10 calories of glucose as compared to a non-calorie placebo (0 calorie beverage) on self-control over resisting snack foods. To test whether there is a threshold of glucose that will result in improved ease of resistance to problem foods (tested by comparing three different levels of glucose).

Detailed description: Ingestion of 100 calories of glucose during individually pre-determined times of waning dietary self-control will result in improved ease of resistance to problem foods when compared to ingestion of lower calories of glucose or placebo (0 calorie beverage)

Eligibility criteria: Inclusion Criteria:

1. Females ages 18 - 65 years.
2. Self-identify as regular snackers, with a specific problem food, who have trouble with over-consuming this snack food.
3. Have intentionally lost weight in the last year and are seeking to maintain that weight loss or have unintentionally gained weight in the last year and are concerned about it.
4. Generally healthy.

Exclusion Criteria:

1. Pregnant or trying to become pregnant.
2. Diagnosis of type 1 or type 2 diabetes
3. Not willing or able to follow study guidelines (ie: consuming the study beverage daily for four weeks, or completing daily compliance logs)
4. Current smoker (or has stopped smoking within the last 6 months)
5. Taking medications that could cause weight loss or weight gain (such as steroids, tricyclic antidepressants, chemotherapy, antipsychotics, prescribed or over the counter weight loss agents, etc).
6. Current or history of eating disorder (anorexia, bulimia, or diagnosed binge eating disorder)
7. Current alcohol or drug abuse or dependence
8. Any medical condition for which daily snacking of such problem foods would be inadvisable (i.e.: a subject with hypertension advised to avoid sodium).

Primary outcomes:
measure: Responses to the Control of Eating Questionnaire
timeFrame: 4 weeks
Secondary outcomes:
measure: Number of Days That a Problem Snack Food Was Consumed at the Identified Time of Waning Dietary Self-control.
timeFrame: 4 weeks
measure: Number of Days That a Problem Snack Food Was Consumed at Any Time of Day in a Week.
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Anschutz Health and Wellness Center
state: Colorado
Study officials:
affiliation: Anschutz Health and Wellness Center
name: James O Hill, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Hofmann W, Adriaanse M, Vohs KD, Baumeister RF. Dieting and the self-control of eating in everyday environments: an experience sampling study. Br J Health Psychol. 2014 Sep;19(3):523-39. doi: 10.1111/bjhp.12053. Epub 2013 Jun 10.