A Pilot Study: Snacking, Willpower and Glucose Availability

NCT ID: NCT02258477

Last Updated: 2016-03-04

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

37 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2015-02-28

Brief Summary

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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

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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)

Conditions

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Willpower

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Sequence 1

Intervention Type 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 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.

Group Type ACTIVE_COMPARATOR

Sequence 2

Intervention Type 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 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.

Group Type ACTIVE_COMPARATOR

Sequence 3

Intervention Type 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 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.

Group Type ACTIVE_COMPARATOR

Sequence 4

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type 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.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Johnson & Johnson

INDUSTRY

Sponsor Role collaborator

University of Colorado, Denver

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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James O Hill, PhD

Role: PRINCIPAL_INVESTIGATOR

Anschutz Health and Wellness Center

Locations

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Anschutz Health and Wellness Center

Aurora, Colorado, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 24261006 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23823705 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23147189 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18315798 (View on PubMed)

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.

Reference Type 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.

Reference Type RESULT
PMID: 18453466 (View on PubMed)

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.

Reference Type RESULT
PMID: 23751109 (View on PubMed)

Other Identifiers

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14-1485

Identifier Type: -

Identifier Source: org_study_id

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