A Pilot Study: Snacking, Willpower and Glucose Availability

NCT02258477 | Completed Results

• 1 other identifier: 14-1485
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

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).

Conditions

Willpower

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Number of Days That a Problem Snack Food Was Consumed at the Identified Time of Waning Dietary Self-control.

  4 weeks

• Number of Days That a Problem Snack Food Was Consumed at Any Time of Day in a Week.

  4 weeks

Study Arms (4)

Sequence 1 (D-B-A-C)

ACTIVE COMPARATOR

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

Sequence 2 (A-D-C-B)

ACTIVE COMPARATOR

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

Sequence 3 (C-A-B-D)

ACTIVE COMPARATOR

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

Sequence 4 (B-C-D-A)

ACTIVE COMPARATOR

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

Interventions

Sequence 1 DIETARY_SUPPLEMENT

100 calorie beverage during week 1; 10 calorie beverage during week 2; control beverage beverage during week 3; 50 calorie beverage during week 4.

Sequence 1 (D-B-A-C)

Sequence 2 DIETARY_SUPPLEMENT

Control beverage during week 1; 100 calorie beverage during week 2; 50 calorie beverage during week 3; 10 calorie beverage during week 4.

Sequence 2 (A-D-C-B)

Sequence 3 DIETARY_SUPPLEMENT

50 calorie beverage during week 1; control beverage during week 2; 10 calorie beverage during week 3; 100 calorie beverage during week 4.

Sequence 3 (C-A-B-D)

Sequence 4 DIETARY_SUPPLEMENT

10 calorie beverage during week 1; 50 calorie beverage during week 2; 100 calorie beverage during week 3; control beverage during week 4.

Sequence 4 (B-C-D-A)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Females ages 18 - 65 years.
• Self-identify as regular snackers, with a specific problem food, who have trouble with over-consuming this snack food.
• 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.
• Generally healthy.

You may not qualify if:

• Pregnant or trying to become pregnant.
• Diagnosis of type 1 or type 2 diabetes
• Not willing or able to follow study guidelines (ie: consuming the study beverage daily for four weeks, or completing daily compliance logs)
• Current smoker (or has stopped smoking within the last 6 months)
• 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).
• Current or history of eating disorder (anorexia, bulimia, or diagnosed binge eating disorder)
• Current alcohol or drug abuse or dependence
• Any medical condition for which daily snacking of such problem foods would be inadvisable (i.e.: a subject with hypertension advised to avoid sodium).

Sponsors & Collaborators

• University of Colorado, Denver: lead
• Johnson & Johnson: collaborator

Study Sites (1)

Anschutz Health and Wellness Center

Aurora, Colorado, 80045, United States

Location

Related Publications (7)

• 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.

  PMID: 24261006 BACKGROUND

• 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.

  PMID: 23823705 BACKGROUND

• 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.

  PMID: 23147189 BACKGROUND

• 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.

  PMID: 18315798 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 18453466 RESULT

• 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.

  PMID: 23751109 RESULT

MeSH Terms

Conditions

Self-Control

Condition Hierarchy (Ancestors)

Social Behavior; Behavior

Limitations and Caveats

The study questionnaire involved limitations as questions were subjective in terms of how subjects defined cravings and snacking behavior. Also, food diaries may not be fully accurate accounts of subjects' actual caloric intake and food consumption.

Results Point of Contact

• Title: Dr. James Hill
• Organization: University of Colorado, Anschutz Health and Wellness Center

james.hill@ucdenver.edu

303-724-9974

Study Officials

• James O Hill, PhD

  Anschutz Health and Wellness Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 2, 2014
• First Posted: October 7, 2014
• Study Start: October 1, 2014
• Primary Completion: January 1, 2015
• Study Completion: February 1, 2015
• Last Updated: March 4, 2016
• Results First Posted: March 4, 2016

Record last verified: 2016-02

Locations

US (1)