A Pilot Study: Snacking, Willpower and Glucose Availability

Study Overview
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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)

Official Title
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A Pilot Study: Snacking, Willpower and Glucose Availability

Conditions
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Willpower

Intervention / Treatment
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* Dietary Supplement: Sequence 1
* Dietary Supplement: Sequence 2
* Dietary Supplement: Sequence 3
* Dietary Supplement: Sequence 4


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

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

What is the study measuring?
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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 |