Trial Outcomes & Findings for A Pilot Study: Snacking, Willpower and Glucose Availability (NCT NCT02258477)

Last Updated: 2016-03-04

Results Overview

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).

Recruitment status

COMPLETED

Study phase

Target enrollment

37 participants

Primary outcome timeframe

4 weeks

Results posted on

2016-03-04

Participant Flow

Subjects were recruited using study flyers and the study was posted on the Center website.

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.

Participant milestones

Participant milestones
Measure	Sequence 1 (D-B-A-C) Subjects assigned to sequence 1 received 100 calorie beverage in week 1, 10 calorie beverage in week 2, 0 calorie control beverage in week 3, and 50 calorie beverage in week 4.	Sequence 2 (A-D-C-B) Subjects in sequence 2 received 0 calorie control beverage in week 1, 100 calorie beverage in week 2, 50 calorie beverage in week 3, and 10 calorie beverage in week 4.	Sequence 3 (C-A-B-D) Subjects in sequence 3 received 50 calorie beverage in week 1, 0 calorie control beverage in week 2, 20 calorie beverage in week 3, and 100 calorie beverage in week 4.	Sequence 4 (B-C-D-A) Subjects in sequence 4 received 10 calorie beverage in week 1, 50 calorie beverage in week 2, 100 calorie beverage in week 3, and 0 calorie control beverage in week 4.
First Intervention (1 Week) STARTED	10	9	9	9
First Intervention (1 Week) COMPLETED	9	8	9	9
First Intervention (1 Week) NOT COMPLETED	1	1	0	0
Second Intervention (1 Week) STARTED	9	8	9	9
Second Intervention (1 Week) COMPLETED	9	8	8	8
Second Intervention (1 Week) NOT COMPLETED	0	0	1	1
Third Intervention (1 Week) STARTED	9	8	8	8
Third Intervention (1 Week) COMPLETED	9	8	8	8
Third Intervention (1 Week) NOT COMPLETED	0	0	0	0
Fourth Intervention (1 Week) STARTED	9	8	8	8
Fourth Intervention (1 Week) COMPLETED	9	8	8	8
Fourth Intervention (1 Week) NOT COMPLETED	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Pilot Study: Snacking, Willpower and Glucose Availability

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Study Subjects n=37 Participants 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.
Age, Customized	44.6 years STANDARD_DEVIATION 12.5 • n=5 Participants
Sex: Female, Male Female	37 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	8 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	29 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	5 Participants n=5 Participants
Race (NIH/OMB) White	24 Participants n=5 Participants
Race (NIH/OMB) More than one race	3 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	5 Participants n=5 Participants
Region of Enrollment United States	37 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

SECONDARY outcome

Timeframe: 4 weeks

Population: 33 subjects completed the 4 week study.

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.

Outcome measures

Outcome measures
Measure	Control n=33 Participants 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. 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 was compared. After baseline data collection, eligible participants were randomized into one of the four sequence groups and received each treatment for 1 week.	100 Calorie Glucose Beverage n=33 Participants Compare the efficacy of a 100 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. 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 was compared. After baseline data collection, eligible participants were randomized into one of the four sequence group and receive each treatment for 1 week.	50 Calorie Beverage n=33 Participants Compare the efficacy of a 50 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. 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 was compared. After baseline data collection, eligible participants were randomized into one of the four sequence groups and received each treatment for 1 week.	10 Calorie n=33 Participants Compare the efficacy of a 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. 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 was compared. After baseline data collection, eligible participants were randomized into one of the four sequence groups and received each treatment for 1 week.
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	16.0 percentage of days in a week Standard Deviation 18.8	14.6 percentage of days in a week Standard Deviation 20.0	14.1 percentage of days in a week Standard Deviation 16.7

SECONDARY outcome

Timeframe: 4 weeks

Population: 33 subjects completed the 4 week study.

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.

Outcome measures

Outcome measures
Measure	Control n=33 Participants 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. 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 was compared. After baseline data collection, eligible participants were randomized into one of the four sequence groups and received each treatment for 1 week.	100 Calorie Glucose Beverage n=33 Participants Compare the efficacy of a 100 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. 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 was compared. After baseline data collection, eligible participants were randomized into one of the four sequence group and receive each treatment for 1 week.	50 Calorie Beverage n=33 Participants Compare the efficacy of a 50 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. 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 was compared. After baseline data collection, eligible participants were randomized into one of the four sequence groups and received each treatment for 1 week.	10 Calorie n=33 Participants Compare the efficacy of a 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. 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 was compared. After baseline data collection, eligible participants were randomized into one of the four sequence groups and received each treatment for 1 week.
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	44.1 percentage of days in a week Standard Deviation 30.5	41.0 percentage of days in a week Standard Deviation 28.0	43.3 percentage of days in a week Standard Deviation 27.6

Adverse Events

All Study Subjects

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	All Study Subjects n=37 participants at risk Subjects were randomized into four possible sequences: subjects assigned to sequence 1 received the control beverage first during week 1, then the 10 calorie beverage during week 2, then the 50 calorie beverage during week 3, and then the 100 calorie beverage during week 4. Subjects assigned to sequence 2 received received the 50 calorie beverage during week 1, then the 100 calorie beverage during week 2, then the control beverage during week 3, and then the 50 calorie beverage during week 4. Subejcts assigned to sequence 3 received the 50 calorie beverage during week 1, then the control beverage during week 2, then the 100 calorie beverage during week 3, and then the 10 calorie beverage during week 4. Subjects assigned to sequence 4 received the 100 calorie beverage during week 1, then the 50 calorie beverage during week 2, then the 10 calorie beverage during week 3, and then the control beverage during week 4.
Respiratory, thoracic and mediastinal disorders Upper respiratory infection	10.8% 4/37 • Number of events 4 • Adverse event data were collected during the four-week study for each study participant. Adverse events were collected without regard for the intervention that was being administered.
General disorders fever	2.7% 1/37 • Number of events 1 • Adverse event data were collected during the four-week study for each study participant. Adverse events were collected without regard for the intervention that was being administered.
General disorders migraine	2.7% 1/37 • Number of events 1 • Adverse event data were collected during the four-week study for each study participant. Adverse events were collected without regard for the intervention that was being administered.
Gastrointestinal disorders stomach ache	2.7% 1/37 • Number of events 1 • Adverse event data were collected during the four-week study for each study participant. Adverse events were collected without regard for the intervention that was being administered.
General disorders jitteriness	2.7% 1/37 • Number of events 1 • Adverse event data were collected during the four-week study for each study participant. Adverse events were collected without regard for the intervention that was being administered.
General disorders Flu	2.7% 1/37 • Number of events 1 • Adverse event data were collected during the four-week study for each study participant. Adverse events were collected without regard for the intervention that was being administered.
Musculoskeletal and connective tissue disorders bursitis	2.7% 1/37 • Adverse event data were collected during the four-week study for each study participant. Adverse events were collected without regard for the intervention that was being administered.
General disorders dry mouth	2.7% 1/37 • Number of events 1 • Adverse event data were collected during the four-week study for each study participant. Adverse events were collected without regard for the intervention that was being administered.
Gastrointestinal disorders upset stomach	2.7% 1/37 • Number of events 1 • Adverse event data were collected during the four-week study for each study participant. Adverse events were collected without regard for the intervention that was being administered.
Gastrointestinal disorders diarrhea	2.7% 1/37 • Number of events 1 • Adverse event data were collected during the four-week study for each study participant. Adverse events were collected without regard for the intervention that was being administered.
Gastrointestinal disorders nausea	2.7% 1/37 • Number of events 1 • Adverse event data were collected during the four-week study for each study participant. Adverse events were collected without regard for the intervention that was being administered.
Gastrointestinal disorders bloating	2.7% 1/37 • Number of events 1 • Adverse event data were collected during the four-week study for each study participant. Adverse events were collected without regard for the intervention that was being administered.

Additional Information

Dr. James Hill

University of Colorado, Anschutz Health and Wellness Center

Phone: 303-724-9974

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Control n=33 Participants 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. 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 was compared. After baseline data collection, eligible participants were randomized into one of the four sequence groups and received each treatment for 1 week.	100 Calorie Glucose Beverage n=33 Participants Compare the efficacy of a 100 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. 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 was compared. After baseline data collection, eligible participants were randomized into one of the four sequence group and receive each treatment for 1 week.	50 Calorie Beverage n=33 Participants Compare the efficacy of a 50 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. 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 was compared. After baseline data collection, eligible participants were randomized into one of the four sequence groups and received each treatment for 1 week.	10 Calorie n=33 Participants Compare the efficacy of a 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. 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 was compared. After baseline data collection, eligible participants were randomized into one of the four sequence groups and received each treatment for 1 week.
Responses to the Control of Eating Questionnaire Question 1: frequency of food cravings	4.5 units on a scale Standard Deviation 2.1	5.2 units on a scale Standard Deviation 2.7	5.1 units on a scale Standard Deviation 2.4	5.2 units on a scale Standard Deviation 2.4
Responses to the Control of Eating Questionnaire Question 2: strength of cravings	4.6 units on a scale Standard Deviation 2.3	5.0 units on a scale Standard Deviation 2.6	4.8 units on a scale Standard Deviation 2.6	5.1 units on a scale Standard Deviation 2.4
Responses to the Control of Eating Questionnaire Question 3: difficulty to resisit cravings	4.3 units on a scale Standard Deviation 2.5	5.2 units on a scale Standard Deviation 2.8	5.0 units on a scale Standard Deviation 2.6	5.5 units on a scale Standard Deviation 2.7
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	4.8 units on a scale Standard Deviation 2.6	5.1 units on a scale Standard Deviation 2.4	4.9 units on a scale Standard Deviation 2.1
Responses to the Control of Eating Questionnaire Question 5: Freq of cravings for chocolate	3.6 units on a scale Standard Deviation 2.4	4.0 units on a scale Standard Deviation 2.7	3.9 units on a scale Standard Deviation 2.6	4.6 units on a scale Standard Deviation 2.6
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	4.5 units on a scale Standard Deviation 2.8	4.5 units on a scale Standard Deviation 2.8	4.6 units on a scale Standard Deviation 2.8
Responses to the Control of Eating Questionnaire Question 7: Freq of cravings for fruit	2.5 units on a scale Standard Deviation 1.7	2.9 units on a scale Standard Deviation 2.0	2.7 units on a scale Standard Deviation 1.8	2.9 units on a scale Standard Deviation 1.6
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	4.3 units on a scale Standard Deviation 2.3	4.6 units on a scale Standard Deviation 2.3	4.7 units on a scale Standard Deviation 2.4
Responses to the Control of Eating Questionnaire Question 11: Freq of eating problem food	4.9 units on a scale Standard Deviation 2.6	4.9 units on a scale Standard Deviation 3.2	4.6 units on a scale Standard Deviation 2.9	4.8 units on a scale Standard Deviation 2.8
Responses to the Control of Eating Questionnaire Question 12: Difficulty resisting problem food	5.1 units on a scale Standard Deviation 2.5	6.4 units on a scale Standard Deviation 3.1	5.5 units on a scale Standard Deviation 2.9	6.2 units on a scale Standard Deviation 2.7
Responses to the Control of Eating Questionnaire Question 13: Difficulty controlling eating	4.6 units on a scale Standard Deviation 1.8	5.8 units on a scale Standard Deviation 2.9	5.9 units on a scale Standard Deviation 2.5	5.5 units on a scale Standard Deviation 2.2
Responses to the Control of Eating Questionnaire Question 14: Freq of snacking	5.5 units on a scale Standard Deviation 2.4	6.0 units on a scale Standard Deviation 2.8	6.1 units on a scale Standard Deviation 2.5	6.3 units on a scale Standard Deviation 2.3
Responses to the Control of Eating Questionnaire Question 15: Freq of skipping meals	3.0 units on a scale Standard Deviation 1.9	2.8 units on a scale Standard Deviation 2.0	2.8 units on a scale Standard Deviation 1.7	2.9 units on a scale Standard Deviation 1.8
Responses to the Control of Eating Questionnaire Question 16: Frequency of eating alone	5.3 units on a scale Standard Deviation 2.8	5.0 units on a scale Standard Deviation 2.8	5.4 units on a scale Standard Deviation 2.7	5.4 units on a scale Standard Deviation 2.5
Responses to the Control of Eating Questionnaire Question #17: Freq of eating alone	5.9 units on a scale Standard Deviation 2.5	6.2 units on a scale Standard Deviation 2.8	5.7 units on a scale Standard Deviation 2.5	5.9 units on a scale Standard Deviation 2.7
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	5.8 units on a scale Standard Deviation 2.6	5.6 units on a scale Standard Deviation 2.2	6.0 units on a scale Standard Deviation 2.4
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	4.7 units on a scale Standard Deviation 2.5	4.7 units on a scale Standard Deviation 2.6	4.7 units on a scale Standard Deviation 2.3
Responses to the Control of Eating Questionnaire Question 20: Freq of watching calories/portions	5.7 units on a scale Standard Deviation 2.6	5.6 units on a scale Standard Deviation 3.2	5.4 units on a scale Standard Deviation 2.7	5.6 units on a scale Standard Deviation 2.9