Willpower
Conditions
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)
Interventions
DIETARY_SUPPLEMENTSequence 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.
DIETARY_SUPPLEMENTSequence 2
Control beverage during week 1; 100 calorie beverage during week 2; 50 calorie beverage during week 3; 10 calorie beverage during week 4.
DIETARY_SUPPLEMENTSequence 3
50 calorie beverage during week 1; control beverage during week 2; 10 calorie beverage during week 3; 100 calorie beverage during week 4.
DIETARY_SUPPLEMENTSequence 4
10 calorie beverage during week 1; 50 calorie beverage during week 2; 100 calorie beverage during week 3; control beverage during week 4.
Sponsors
Johnson & Johnson
University of Colorado, Denver
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
Yes
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Responses to the Control of Eating Questionnaire | 4 weeks | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Days That a Problem Snack Food Was Consumed at the Identified Time of Waning Dietary Self-control. | 4 weeks | 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. |
| Number of Days That a Problem Snack Food Was Consumed at Any Time of Day in a Week. | 4 weeks | 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. |
Countries
United States
Participant flow
Recruitment details
Subjects were recruited using study flyers and the study was posted on the Center website.
Pre-assignment details
Note, that each subject participated in the study for four weeks, consuming a different study beverage daily for one week, being crossed-over to another beverage the following week. Thus a total of 33 subjects completed all four weeks of the cross-over study.
Participants by arm
| Arm | Count |
|---|---|
| All Study Subjects Compare the efficacy of 0 calorie sucralose-sweetened water on the behavioral ease of resisting problem foods during time of vulnerability to the problem food.
Glucose: This is a randomized, double-blind cross-over pilot study involving 40 study subjects. We will compare the efficacy of a 100, 50, and 10 calorie glucose beverage versus an identical volume of placebo beverage (0 calorie sucralose-sweetened water) on the behavioral ease of resisting problem foods during time of vulnerability to the problem food. After baseline data collection, eligible participants will be randomized into one of the four sequence group and receive a different beverage each week. | 37 |
| Total | 37 |
Baseline characteristics
| Characteristic | All Study Subjects |
|---|---|
| Age, Customized | 44.6 years STANDARD_DEVIATION 12.5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 8 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 29 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants |
| Race (NIH/OMB) More than one race | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 5 Participants |
| Race (NIH/OMB) White | 24 Participants |
| Region of Enrollment United States | 37 participants |
| Sex: Female, Male Female | 37 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 9 / 37 |
| serious Total, serious adverse events | 0 / 37 |
Outcome results
Primary
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).
Time frame: 4 weeks
Population: 33 participants completed the 4 week study and were randomized to one of four treatment sequences. Thus, each subject received each treatment for one week.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control | Responses to the Control of Eating Questionnaire | Question 15: Freq of skipping meals | 3.0 units on a scale | Standard Deviation 1.9 |
| Control | Responses to the Control of Eating Questionnaire | Question 3: difficulty to resisit cravings | 4.3 units on a scale | Standard Deviation 2.5 |
| Control | Responses to the Control of Eating Questionnaire | Question 2: strength of cravings | 4.6 units on a scale | Standard Deviation 2.3 |
| Control | Responses to the Control of Eating Questionnaire | Question 6: Freq of cravings for other sweet foods | 3.8 units on a scale | Standard Deviation 2.6 |
| Control | Responses to the Control of Eating Questionnaire | Question 16: Frequency of eating alone | 5.3 units on a scale | Standard Deviation 2.8 |
| Control | Responses to the Control of Eating Questionnaire | Question 20: Freq of watching calories/portions | 5.7 units on a scale | Standard Deviation 2.6 |
| Control | Responses to the Control of Eating Questionnaire | Question 12: Difficulty resisting problem food | 5.1 units on a scale | Standard Deviation 2.5 |
| Control | Responses to the Control of Eating Questionnaire | Question 7: Freq of cravings for fruit | 2.5 units on a scale | Standard Deviation 1.7 |
| Control | Responses to the Control of Eating Questionnaire | Question #17: Freq of eating alone | 5.9 units on a scale | Standard Deviation 2.5 |
| Control | Responses to the Control of Eating Questionnaire | Question 14: Freq of snacking | 5.5 units on a scale | Standard Deviation 2.4 |
| Control | Responses to the Control of Eating Questionnaire | Question 8: Freq of cravings for savory foods | 4.1 units on a scale | Standard Deviation 2.1 |
| Control | Responses to the Control of Eating Questionnaire | Question 5: Freq of cravings for chocolate | 3.6 units on a scale | Standard Deviation 2.4 |
| Control | Responses to the Control of Eating Questionnaire | Question 18: Freq of eating while doing other | 5.9 units on a scale | Standard Deviation 2.4 |
| Control | Responses to the Control of Eating Questionnaire | Question 1: frequency of food cravings | 4.5 units on a scale | Standard Deviation 2.1 |
| Control | Responses to the Control of Eating Questionnaire | Question 11: Freq of eating problem food | 4.9 units on a scale | Standard Deviation 2.6 |
| Control | Responses to the Control of Eating Questionnaire | Question 4: frequency of eating due to cravings | 4.2 units on a scale | Standard Deviation 1.8 |
| Control | Responses to the Control of Eating Questionnaire | Question 19: Freq of eating more than intended | 3.9 units on a scale | Standard Deviation 2.2 |
| Control | Responses to the Control of Eating Questionnaire | Question 13: Difficulty controlling eating | 4.6 units on a scale | Standard Deviation 1.8 |
| 100 Calorie Glucose Beverage | Responses to the Control of Eating Questionnaire | Question 19: Freq of eating more than intended | 4.7 units on a scale | Standard Deviation 2.5 |
| 100 Calorie Glucose Beverage | Responses to the Control of Eating Questionnaire | Question 20: Freq of watching calories/portions | 5.6 units on a scale | Standard Deviation 3.2 |
| 100 Calorie Glucose Beverage | Responses to the Control of Eating Questionnaire | Question 3: difficulty to resisit cravings | 5.2 units on a scale | Standard Deviation 2.8 |
| 100 Calorie Glucose Beverage | Responses to the Control of Eating Questionnaire | Question 1: frequency of food cravings | 5.2 units on a scale | Standard Deviation 2.7 |
| 100 Calorie Glucose Beverage | Responses to the Control of Eating Questionnaire | Question 13: Difficulty controlling eating | 5.8 units on a scale | Standard Deviation 2.9 |
| 100 Calorie Glucose Beverage | Responses to the Control of Eating Questionnaire | Question 2: strength of cravings | 5.0 units on a scale | Standard Deviation 2.6 |
| 100 Calorie Glucose Beverage | Responses to the Control of Eating Questionnaire | Question 14: Freq of snacking | 6.0 units on a scale | Standard Deviation 2.8 |
| 100 Calorie Glucose Beverage | Responses to the Control of Eating Questionnaire | Question 12: Difficulty resisting problem food | 6.4 units on a scale | Standard Deviation 3.1 |
| 100 Calorie Glucose Beverage | Responses to the Control of Eating Questionnaire | Question 6: Freq of cravings for other sweet foods | 4.5 units on a scale | Standard Deviation 2.8 |
| 100 Calorie Glucose Beverage | Responses to the Control of Eating Questionnaire | Question 15: Freq of skipping meals | 2.8 units on a scale | Standard Deviation 2 |
| 100 Calorie Glucose Beverage | Responses to the Control of Eating Questionnaire | Question 11: Freq of eating problem food | 4.9 units on a scale | Standard Deviation 3.2 |
| 100 Calorie Glucose Beverage | Responses to the Control of Eating Questionnaire | Question 16: Frequency of eating alone | 5.0 units on a scale | Standard Deviation 2.8 |
| 100 Calorie Glucose Beverage | Responses to the Control of Eating Questionnaire | Question 8: Freq of cravings for savory foods | 4.3 units on a scale | Standard Deviation 2.3 |
| 100 Calorie Glucose Beverage | Responses to the Control of Eating Questionnaire | Question 5: Freq of cravings for chocolate | 4.0 units on a scale | Standard Deviation 2.7 |
| 100 Calorie Glucose Beverage | Responses to the Control of Eating Questionnaire | Question #17: Freq of eating alone | 6.2 units on a scale | Standard Deviation 2.8 |
| 100 Calorie Glucose Beverage | Responses to the Control of Eating Questionnaire | Question 18: Freq of eating while doing other | 5.8 units on a scale | Standard Deviation 2.6 |
| 100 Calorie Glucose Beverage | Responses to the Control of Eating Questionnaire | Question 4: frequency of eating due to cravings | 4.8 units on a scale | Standard Deviation 2.6 |
| 100 Calorie Glucose Beverage | Responses to the Control of Eating Questionnaire | Question 7: Freq of cravings for fruit | 2.9 units on a scale | Standard Deviation 2 |
| 50 Calorie Beverage | Responses to the Control of Eating Questionnaire | Question 19: Freq of eating more than intended | 4.7 units on a scale | Standard Deviation 2.6 |
| 50 Calorie Beverage | Responses to the Control of Eating Questionnaire | Question 11: Freq of eating problem food | 4.6 units on a scale | Standard Deviation 2.9 |
| 50 Calorie Beverage | Responses to the Control of Eating Questionnaire | Question 12: Difficulty resisting problem food | 5.5 units on a scale | Standard Deviation 2.9 |
| 50 Calorie Beverage | Responses to the Control of Eating Questionnaire | Question 13: Difficulty controlling eating | 5.9 units on a scale | Standard Deviation 2.5 |
| 50 Calorie Beverage | Responses to the Control of Eating Questionnaire | Question 14: Freq of snacking | 6.1 units on a scale | Standard Deviation 2.5 |
| 50 Calorie Beverage | Responses to the Control of Eating Questionnaire | Question 15: Freq of skipping meals | 2.8 units on a scale | Standard Deviation 1.7 |
| 50 Calorie Beverage | Responses to the Control of Eating Questionnaire | Question 16: Frequency of eating alone | 5.4 units on a scale | Standard Deviation 2.7 |
| 50 Calorie Beverage | Responses to the Control of Eating Questionnaire | Question #17: Freq of eating alone | 5.7 units on a scale | Standard Deviation 2.5 |
| 50 Calorie Beverage | Responses to the Control of Eating Questionnaire | Question 18: Freq of eating while doing other | 5.6 units on a scale | Standard Deviation 2.2 |
| 50 Calorie Beverage | Responses to the Control of Eating Questionnaire | Question 8: Freq of cravings for savory foods | 4.6 units on a scale | Standard Deviation 2.3 |
| 50 Calorie Beverage | Responses to the Control of Eating Questionnaire | Question 20: Freq of watching calories/portions | 5.4 units on a scale | Standard Deviation 2.7 |
| 50 Calorie Beverage | Responses to the Control of Eating Questionnaire | Question 1: frequency of food cravings | 5.1 units on a scale | Standard Deviation 2.4 |
| 50 Calorie Beverage | Responses to the Control of Eating Questionnaire | Question 2: strength of cravings | 4.8 units on a scale | Standard Deviation 2.6 |
| 50 Calorie Beverage | Responses to the Control of Eating Questionnaire | Question 3: difficulty to resisit cravings | 5.0 units on a scale | Standard Deviation 2.6 |
| 50 Calorie Beverage | Responses to the Control of Eating Questionnaire | Question 4: frequency of eating due to cravings | 5.1 units on a scale | Standard Deviation 2.4 |
| 50 Calorie Beverage | Responses to the Control of Eating Questionnaire | Question 5: Freq of cravings for chocolate | 3.9 units on a scale | Standard Deviation 2.6 |
| 50 Calorie Beverage | Responses to the Control of Eating Questionnaire | Question 6: Freq of cravings for other sweet foods | 4.5 units on a scale | Standard Deviation 2.8 |
| 50 Calorie Beverage | Responses to the Control of Eating Questionnaire | Question 7: Freq of cravings for fruit | 2.7 units on a scale | Standard Deviation 1.8 |
| 10 Calorie | Responses to the Control of Eating Questionnaire | Question 19: Freq of eating more than intended | 4.7 units on a scale | Standard Deviation 2.3 |
| 10 Calorie | Responses to the Control of Eating Questionnaire | Question 18: Freq of eating while doing other | 6.0 units on a scale | Standard Deviation 2.4 |
| 10 Calorie | Responses to the Control of Eating Questionnaire | Question 8: Freq of cravings for savory foods | 4.7 units on a scale | Standard Deviation 2.4 |
| 10 Calorie | Responses to the Control of Eating Questionnaire | Question 4: frequency of eating due to cravings | 4.9 units on a scale | Standard Deviation 2.1 |
| 10 Calorie | Responses to the Control of Eating Questionnaire | Question #17: Freq of eating alone | 5.9 units on a scale | Standard Deviation 2.7 |
| 10 Calorie | Responses to the Control of Eating Questionnaire | Question 16: Frequency of eating alone | 5.4 units on a scale | Standard Deviation 2.5 |
| 10 Calorie | Responses to the Control of Eating Questionnaire | Question 7: Freq of cravings for fruit | 2.9 units on a scale | Standard Deviation 1.6 |
| 10 Calorie | Responses to the Control of Eating Questionnaire | Question 5: Freq of cravings for chocolate | 4.6 units on a scale | Standard Deviation 2.6 |
| 10 Calorie | Responses to the Control of Eating Questionnaire | Question 15: Freq of skipping meals | 2.9 units on a scale | Standard Deviation 1.8 |
| 10 Calorie | Responses to the Control of Eating Questionnaire | Question 14: Freq of snacking | 6.3 units on a scale | Standard Deviation 2.3 |
| 10 Calorie | Responses to the Control of Eating Questionnaire | Question 11: Freq of eating problem food | 4.8 units on a scale | Standard Deviation 2.8 |
| 10 Calorie | Responses to the Control of Eating Questionnaire | Question 6: Freq of cravings for other sweet foods | 4.6 units on a scale | Standard Deviation 2.8 |
| 10 Calorie | Responses to the Control of Eating Questionnaire | Question 13: Difficulty controlling eating | 5.5 units on a scale | Standard Deviation 2.2 |
| 10 Calorie | Responses to the Control of Eating Questionnaire | Question 2: strength of cravings | 5.1 units on a scale | Standard Deviation 2.4 |
| 10 Calorie | Responses to the Control of Eating Questionnaire | Question 1: frequency of food cravings | 5.2 units on a scale | Standard Deviation 2.4 |
| 10 Calorie | Responses to the Control of Eating Questionnaire | Question 20: Freq of watching calories/portions | 5.6 units on a scale | Standard Deviation 2.9 |
| 10 Calorie | Responses to the Control of Eating Questionnaire | Question 12: Difficulty resisting problem food | 6.2 units on a scale | Standard Deviation 2.7 |
| 10 Calorie | Responses to the Control of Eating Questionnaire | Question 3: difficulty to resisit cravings | 5.5 units on a scale | Standard Deviation 2.7 |
Secondary
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.
Time frame: 4 weeks
Population: 33 subjects completed the 4 week study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Number of Days That a Problem Snack Food Was Consumed at Any Time of Day in a Week. | 41.3 percentage of days in a week | Standard Deviation 23.6 |
| 100 Calorie Glucose Beverage | Number of Days That a Problem Snack Food Was Consumed at Any Time of Day in a Week. | 44.1 percentage of days in a week | Standard Deviation 30.5 |
| 50 Calorie Beverage | Number of Days That a Problem Snack Food Was Consumed at Any Time of Day in a Week. | 41.0 percentage of days in a week | Standard Deviation 28 |
| 10 Calorie | Number of Days That a Problem Snack Food Was Consumed at Any Time of Day in a Week. | 43.3 percentage of days in a week | Standard Deviation 27.6 |
Secondary
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.
Time frame: 4 weeks
Population: 33 subjects completed the 4 week study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Number of Days That a Problem Snack Food Was Consumed at the Identified Time of Waning Dietary Self-control. | 13.3 percentage of days in a week | Standard Deviation 14.2 |
| 100 Calorie Glucose Beverage | Number of Days That a Problem Snack Food Was Consumed at the Identified Time of Waning Dietary Self-control. | 16.0 percentage of days in a week | Standard Deviation 18.8 |
| 50 Calorie Beverage | Number of Days That a Problem Snack Food Was Consumed at the Identified Time of Waning Dietary Self-control. | 14.6 percentage of days in a week | Standard Deviation 20 |
| 10 Calorie | Number of Days That a Problem Snack Food Was Consumed at the Identified Time of Waning Dietary Self-control. | 14.1 percentage of days in a week | Standard Deviation 16.7 |