A Pilot Study: Snacking, Willpower and Glucose Availability (SWG)

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).

Study Overview

• Status: Completed
• Conditions: Willpower
• Intervention / Treatment: Dietary supplement: Sequence 1; Dietary supplement: Sequence 2; Dietary supplement: Sequence 3; Dietary supplement: Sequence 4

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)

• Study Type: Interventional
• Enrollment (Actual): 37
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Anschutz Health and Wellness Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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).

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Sequence 1 (D-B-A-C); 100 calorie beverage during week 1; 10 calorie beverage during week 2; control beverage beverage during week 3; 50 calorie beverage during week 4.	Dietary supplement: Sequence 1; 100 calorie beverage during week 1; 10 calorie beverage during week 2; control beverage beverage during week 3; 50 calorie beverage during week 4.
Active Comparator: Sequence 2 (A-D-C-B); Control beverage during week 1; 100 calorie beverage during week 2; 50 calorie beverage during week 3; 10 calorie beverage during week 4.	Dietary supplement: Sequence 2; Control beverage during week 1; 100 calorie beverage during week 2; 50 calorie beverage during week 3; 10 calorie beverage during week 4.
Active Comparator: Sequence 3 (C-A-B-D); 50 calorie beverage during week 1; control beverage during week 2; 10 calorie beverage during week 3; 100 calorie beverage during week 4.	Dietary supplement: Sequence 3; 50 calorie beverage during week 1; control beverage during week 2; 10 calorie beverage during week 3; 100 calorie beverage during week 4.
Active Comparator: Sequence 4 (B-C-D-A); 10 calorie beverage during week 1; 50 calorie beverage during week 2; 100 calorie beverage during week 3; control beverage during week 4.	Dietary supplement: Sequence 4; 10 calorie beverage during week 1; 50 calorie beverage during week 2; 100 calorie beverage during week 3; control beverage during week 4.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Responses to the Control of Eating Questionnaire	Study participant will complete Eating Questionnaire at baseline and the next 4 visits. Each questionnaire item used a likert scale (with ratings from 1 - 10). All question pertain to the last 7 days. Questionnaire items #9 asked "what one food makes it most difficult for you to control eating?" and question #10 asked " What time are you particularly vulnerable to this one food." Higher ratings are consistent with a more significant or more frequent outcome. Note that values in the data table below are absolute scores at each week that the subject consumed the noted treatment dose. As subjects were randomized to different sequence orders to receive the study beverages, subjects consumed any given treatment dose at different weeks (depending on their randomized sequence order).	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Days That a Problem Snack Food Was Consumed at the Identified Time of Waning Dietary Self-control.	Study participant will record if the problem snack was consumed each day within the 3 hour period following consumption of the study beverage. Note that the values in the data table below reflect the percentage of days within a week that subjects within each treatment dose consumed a problem snack food at the identified time of waning dietary self-control. The data does not represent change from baseline, but rather percentage of days within a week (calculated by how many days within a week subject consumed the problem snack food at the identified time of waning dietary self-control/ 7 days in a week) and can be compared week by week to see if there is any significant difference weekly when consuming a different dose of glucose.	4 weeks
Number of Days That a Problem Snack Food Was Consumed at Any Time of Day in a Week.	Study participant will record daily the time problem snack food was consumed. Note that the values in the data table below reflect the percentage of days within a week that subjects within each treatment dose consumed a problem snack food at any time of day. The data does not represent change from baseline, but rather percentage of days within a week (calculated by how many days within a week subject consumed the problem snack food at any time of day/ 7 days in a week) and can be compared week by week to see if there is any significant difference weekly when consuming a different dose of glucose.	4 weeks

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Collaborators: Johnson & Johnson
• Investigators: Principal Investigator: James O Hill, PhD, Anschutz Health and Wellness Center

Publications and helpful links

General Publications

• Hand GA, Shook RP, Paluch AE, Baruth M, Crowley EP, Jaggers JR, Prasad VK, Hurley TG, Hebert JR, O'Connor DP, Archer E, Burgess S, Blair SN. The energy balance study: the design and baseline results for a longitudinal study of energy balance. Res Q Exerc Sport. 2013 Sep;84(3):275-86. doi: 10.1080/02701367.2013.816224.
• Chang SH, Pollack LM, Colditz GA. Life Years Lost Associated with Obesity-Related Diseases for U.S. Non-Smoking Adults. PLoS One. 2013 Jun 18;8(6):e66550. doi: 10.1371/journal.pone.0066550. Print 2013.
• Dulloo AG. Explaining the failures of obesity therapy: willpower attenuation, target miscalculation or metabolic compensation? Int J Obes (Lond). 2012 Nov;36(11):1418-20. doi: 10.1038/ijo.2012.114. No abstract available.
• Masicampo EJ, Baumeister RF. Toward a physiology of dual-process reasoning and judgment: lemonade, willpower, and expensive rule-based analysis. Psychol Sci. 2008 Mar;19(3):255-60. doi: 10.1111/j.1467-9280.2008.02077.x.
• Littell, Ramon C., George A. Milliken, Walter W. Stroup, Russell D. Wolfinger, and O Schabenberger. 2006. SAS@ for Mixed Models, Second Edition. Cary, NC: SAS Institute.
• Gailliot MT, Baumeister RF. The physiology of willpower: linking blood glucose to self-control. Pers Soc Psychol Rev. 2007 Nov;11(4):303-27. doi: 10.1177/1088868307303030.
• 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.

Study record dates

Study Major Dates

• Study Start: October 1, 2014
• Primary Completion (Actual): January 1, 2015
• Study Completion (Actual): February 1, 2015

Study Registration Dates

• First Submitted: October 2, 2014
• First Submitted That Met QC Criteria: October 6, 2014
• First Posted (Estimate): October 7, 2014

Study Record Updates

• Last Update Posted (Estimate): March 4, 2016
• Last Update Submitted That Met QC Criteria: February 4, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: 14-1485