Trial Outcomes & Findings for Dose-ranging Efficacy of Polydextrose Supplement on Colonic Transit Time and Symptoms in Adults With Functional Constipation (NCT NCT02314936)

Results Overview

Assessed using abdominal x-ray. Subjects will take 24 radiopaque markers for 6 consecutive days (144 radiopaque markers in total) immediately preceding the x-ray dates.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

192 participants

Primary outcome timeframe

Baseline and Day 15

Results posted on

2018-11-09

Participant Flow

Participant milestones

Participant milestones
Measure	Litesse Powder Containing 12 g Polydextrose 12 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 12 g polydextrose: 12 g polydextrose	Litesse Powder Containing 8 g Polydextrose 8 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 8 g polydextrose: 8 g polydextrose, 4 g maltodextrin	Litesse Powder Containing 4 g Polydextrose 4 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 4 g polydextrose: 4 g polydextrose, 8 g maltodextrin	Placebo Maltodextrin, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Placebo: 12 g Maltodextrin
Overall Study STARTED	48	48	48	48
Overall Study COMPLETED	48	48	46	48
Overall Study NOT COMPLETED	0	0	2	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Dose-ranging Efficacy of Polydextrose Supplement on Colonic Transit Time and Symptoms in Adults With Functional Constipation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Litesse Powder Containing 12 g Polydextrose n=48 Participants 12 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 12 g polydextrose: 12 g polydextrose	Litesse Powder Containing 8 g Polydextrose n=48 Participants 8 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 8 g polydextrose: 8 g polydextrose, 4 g maltodextrin	Litesse Powder Containing 4 g Polydextrose n=48 Participants 4 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 4 g polydextrose: 4 g polydextrose, 8 g maltodextrin	Placebo n=48 Participants Maltodextrin, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Placebo: 12 g Maltodextrin	Total n=192 Participants Total of all reporting groups
Age, Continuous	42.9 years STANDARD_DEVIATION 16.3 • n=5 Participants	42.9 years STANDARD_DEVIATION 12.5 • n=7 Participants	41.5 years STANDARD_DEVIATION 17.1 • n=5 Participants	43.6 years STANDARD_DEVIATION 13.4 • n=4 Participants	42.7 years STANDARD_DEVIATION 14.8 • n=21 Participants
Sex: Female, Male Female	34 Participants n=5 Participants	34 Participants n=7 Participants	32 Participants n=5 Participants	33 Participants n=4 Participants	133 Participants n=21 Participants
Sex: Female, Male Male	14 Participants n=5 Participants	14 Participants n=7 Participants	16 Participants n=5 Participants	15 Participants n=4 Participants	59 Participants n=21 Participants
Race/Ethnicity, Customized Black or African American	2 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	2 Participants n=21 Participants
Race/Ethnicity, Customized Central American	2 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	4 Participants n=21 Participants
Race/Ethnicity, Customized East Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants	4 Participants n=21 Participants
Race/Ethnicity, Customized Eastern European White	0 Participants n=5 Participants	3 Participants n=7 Participants	0 Participants n=5 Participants	5 Participants n=4 Participants	8 Participants n=21 Participants
Race/Ethnicity, Customized Middle Eastern	2 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	1 Participants n=4 Participants	6 Participants n=21 Participants
Race/Ethnicity, Customized North American Indian	0 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	0 Participants n=4 Participants	2 Participants n=21 Participants
Race/Ethnicity, Customized South American	0 Participants n=5 Participants	6 Participants n=7 Participants	3 Participants n=5 Participants	3 Participants n=4 Participants	12 Participants n=21 Participants
Race/Ethnicity, Customized South Asian	3 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	5 Participants n=21 Participants
Race/Ethnicity, Customized South East Asian	2 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	2 Participants n=21 Participants
Race/Ethnicity, Customized Western European White	36 Participants n=5 Participants	36 Participants n=7 Participants	40 Participants n=5 Participants	35 Participants n=4 Participants	147 Participants n=21 Participants
Body Mass Index	25.27 kg/m^2 STANDARD_DEVIATION 3.06 • n=5 Participants	25.31 kg/m^2 STANDARD_DEVIATION 3.09 • n=7 Participants	25.32 kg/m^2 STANDARD_DEVIATION 2.82 • n=5 Participants	25.23 kg/m^2 STANDARD_DEVIATION 2.48 • n=4 Participants	25.28 kg/m^2 STANDARD_DEVIATION 2.85 • n=21 Participants
Smoking Status Ex-Smoker	7 Participants n=5 Participants	8 Participants n=7 Participants	3 Participants n=5 Participants	7 Participants n=4 Participants	25 Participants n=21 Participants
Smoking Status Non-Smoker	34 Participants n=5 Participants	36 Participants n=7 Participants	40 Participants n=5 Participants	35 Participants n=4 Participants	145 Participants n=21 Participants
Smoking Status Current Smoker	7 Participants n=5 Participants	4 Participants n=7 Participants	5 Participants n=5 Participants	6 Participants n=4 Participants	22 Participants n=21 Participants
Alcohol Use Daily	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	1 Participants n=4 Participants	5 Participants n=21 Participants
Alcohol Use None	9 Participants n=5 Participants	5 Participants n=7 Participants	9 Participants n=5 Participants	9 Participants n=4 Participants	32 Participants n=21 Participants
Alcohol Use Occasionally	27 Participants n=5 Participants	25 Participants n=7 Participants	21 Participants n=5 Participants	27 Participants n=4 Participants	100 Participants n=21 Participants
Alcohol Use Weekly	12 Participants n=5 Participants	16 Participants n=7 Participants	16 Participants n=5 Participants	11 Participants n=4 Participants	55 Participants n=21 Participants

PRIMARY outcome

Timeframe: Baseline and Day 15

Population: The number of participants analysed is the number of participants who met the per protocol population requirement. 17 participants did not meet the per protocol compliance (must have consumed ≥80% of assigned study product and 100% of radio opaque pellets) and 2 participants did not complete the study (did not complete end-of-study visit).

Assessed using abdominal x-ray. Subjects will take 24 radiopaque markers for 6 consecutive days (144 radiopaque markers in total) immediately preceding the x-ray dates.

Outcome measures

Outcome measures
Measure	Litesse Powder Containing 4 g Polydextrose n=43 Participants 4 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 4 g polydextrose: 4 g polydextrose, 8 g maltodextrin	Placebo n=42 Participants Maltodextrin, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Placebo: 12 g Maltodextrin	Litesse Powder Containing 12 g Polydextrose n=45 Participants 12 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 12 g polydextrose: 12 g polydextrose	Litesse Powder Containing 8 g Polydextrose n=43 Participants 8 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 8 g polydextrose: 8 g polydextrose, 4 g maltodextrin
Change in Colonic Transit Time From Baseline to Day 15	2.5 Hours Standard Deviation 23.7	2.6 Hours Standard Deviation 25.9	-1.7 Hours Standard Deviation 23.6	4.0 Hours Standard Deviation 23.4

SECONDARY outcome

Timeframe: Baseline and Day 15

Population: The number of participants analysed is the number of participants who met the per protocol population requirement. 17 participants did not meet the per protocol compliance (must have consumed ≥80% of assigned study product and 100% of radio opaque pellets) and 2 participants did not complete the study (did not complete end-of-study visit).

Assessed using the PAC-SYM questionnaire (overall score, abdominal symptoms score, rectal symptoms score, and stool symptoms score). The PAC-SYM was developed as a brief, easily administered tool to assess symptom frequency and severity of chronic constipation. The authors used a definition for constipation was based on the Rome II criteria. This 12-item self-report measure is divided into the 3 symptom subscales of: abdominal, rectal and stool subscales. All items (sub-scores and the total score) are scored on a five-point Likert scale ranging from 0 (absence of symptom) to 4 (very severe) where lower scores are better. Scores for the total number of non-missing items within the subscale or total score are summed and divided by the total number of non-missing items for that subscale or total score.

Outcome measures

Outcome measures
Measure	Litesse Powder Containing 4 g Polydextrose n=43 Participants 4 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 4 g polydextrose: 4 g polydextrose, 8 g maltodextrin	Placebo n=42 Participants Maltodextrin, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Placebo: 12 g Maltodextrin	Litesse Powder Containing 12 g Polydextrose n=45 Participants 12 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 12 g polydextrose: 12 g polydextrose	Litesse Powder Containing 8 g Polydextrose n=43 Participants 8 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 8 g polydextrose: 8 g polydextrose, 4 g maltodextrin
Change in Participant Assessment of Constipation Symptoms (PAC-SYM) From Baseline to Day 15 Stool Symptoms Score	-0.18 scores on a scale Standard Deviation 0.62	-0.28 scores on a scale Standard Deviation 0.82	-0.31 scores on a scale Standard Deviation 0.82	-0.16 scores on a scale Standard Deviation 0.68
Change in Participant Assessment of Constipation Symptoms (PAC-SYM) From Baseline to Day 15 Abdominal Symptoms Score	-0.01 scores on a scale Standard Deviation 0.56	-0.15 scores on a scale Standard Deviation 0.60	-0.13 scores on a scale Standard Deviation 0.69	-0.06 scores on a scale Standard Deviation 0.51
Change in Participant Assessment of Constipation Symptoms (PAC-SYM) From Baseline to Day 15 Rectal Symptoms Score	0.06 scores on a scale Standard Deviation 0.60	-0.21 scores on a scale Standard Deviation 0.59	-0.28 scores on a scale Standard Deviation 0.71	-0.16 scores on a scale Standard Deviation 0.46
Change in Participant Assessment of Constipation Symptoms (PAC-SYM) From Baseline to Day 15 Overall Score	-0.04 scores on a scale Standard Deviation 0.44	-0.21 scores on a scale Standard Deviation 0.56	-0.24 scores on a scale Standard Deviation 0.59	-0.13 scores on a scale Standard Deviation 0.39

SECONDARY outcome

Timeframe: Baseline and Day 15

Population: The number of participants analysed is the number of participants who met the per protocol population requirement. 17 participants did not meet the per protocol compliance (must have consumed ≥80% of assigned study product and 100% of radio opaque pellets) and 2 participants did not complete the study (did not complete end-of-study visit).

Assessed using the PAC-QoL questionnaire (Overall Score, Worries and Concerns Score, Physical Discomfort Score, Psychosocial Discomfort Score, and Satisfaction Score) The Patient Assessment of Constipation (PAC) was developed to address the need for a disease-specific patient-reported outcomes measure. It includes components from complementary symptom and quality of life questionnaires. The PAC-QOL contains 28 items grouped into 4 subscales covering: worries and concerns (11 items), physical discomfort (4 items), psychosocial discomfort (8 items), and satisfaction (5 items). A 5-point Likert response scale, ranging from 0 (not at all / none of the time) to 4 (extremely / all of the time), where lower scores are better. Scores are computed as the average non-missing item response within the subscale where each score is given equal weight; the global score is calculated as the mean of the 28-items.

Outcome measures

Outcome measures
Measure	Litesse Powder Containing 4 g Polydextrose n=43 Participants 4 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 4 g polydextrose: 4 g polydextrose, 8 g maltodextrin	Placebo n=42 Participants Maltodextrin, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Placebo: 12 g Maltodextrin	Litesse Powder Containing 12 g Polydextrose n=45 Participants 12 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 12 g polydextrose: 12 g polydextrose	Litesse Powder Containing 8 g Polydextrose n=43 Participants 8 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 8 g polydextrose: 8 g polydextrose, 4 g maltodextrin
Change in Participant Assessment of Constipation Quality of Life (PAC-QoL) From Baseline to Day 15 Overall Score	-0.08 scores on a scale Standard Deviation 0.33	-0.11 scores on a scale Standard Deviation 0.33	-0.05 scores on a scale Standard Deviation 0.36	-0.04 scores on a scale Standard Deviation 0.45
Change in Participant Assessment of Constipation Quality of Life (PAC-QoL) From Baseline to Day 15 Worries and Concerns Score	-0.15 scores on a scale Standard Deviation 0.46	-0.13 scores on a scale Standard Deviation 0.60	-0.27 scores on a scale Standard Deviation 0.59	-0.17 scores on a scale Standard Deviation 0.54
Change in Participant Assessment of Constipation Quality of Life (PAC-QoL) From Baseline to Day 15 Physical Discomfort Score	-0.13 scores on a scale Standard Deviation 0.58	-0.20 scores on a scale Standard Deviation 0.75	-0.24 scores on a scale Standard Deviation 0.74	-0.23 scores on a scale Standard Deviation 0.73
Change in Participant Assessment of Constipation Quality of Life (PAC-QoL) From Baseline to Day 15 Psychosocial Discomfort Score	-0.17 scores on a scale Standard Deviation 0.52	-0.09 scores on a scale Standard Deviation 0.53	-0.12 scores on a scale Standard Deviation 0.53	-0.11 scores on a scale Standard Deviation 0.58
Change in Participant Assessment of Constipation Quality of Life (PAC-QoL) From Baseline to Day 15 Satisfaction Score	0.12 scores on a scale Standard Deviation 0.67	-0.02 scores on a scale Standard Deviation 0.69	0.44 scores on a scale Standard Deviation 0.98	0.37 scores on a scale Standard Deviation 0.75

SECONDARY outcome

Timeframe: Baseline and Day 15

Population: The number of participants analysed is the number of participants who met the per protocol population requirement. 17 participants did not meet the per protocol compliance (must have consumed ≥80% of assigned study product and 100% of radio opaque pellets) and 2 participants did not complete the study (did not complete end-of-study visit).

Assessed using the Bowel Function Index questionnaire (total score, ease of defecation, feeling of incomplete bowel evacuation, and personal judgement of constipation). Each of the three questions used a numerical analog scale (0 = easy/no difficulty/not at all, 100 = very strong/very difficult) for grading purposes. The three questions were calculated as single scores as well as by a total score defined as the average of the three questions.

Outcome measures

Outcome measures
Measure	Litesse Powder Containing 4 g Polydextrose n=43 Participants 4 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 4 g polydextrose: 4 g polydextrose, 8 g maltodextrin	Placebo n=42 Participants Maltodextrin, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Placebo: 12 g Maltodextrin	Litesse Powder Containing 12 g Polydextrose n=45 Participants 12 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 12 g polydextrose: 12 g polydextrose	Litesse Powder Containing 8 g Polydextrose n=43 Participants 8 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 8 g polydextrose: 8 g polydextrose, 4 g maltodextrin
Change in Bowel Function Index From Baseline to Day 15 Overall Score	-8.9 scores on a scale Standard Deviation 20.1	-10.2 scores on a scale Standard Deviation 23.4	-9.3 scores on a scale Standard Deviation 23.6	-8.2 scores on a scale Standard Deviation 20.8
Change in Bowel Function Index From Baseline to Day 15 Ease of Defecation	-5.9 scores on a scale Standard Deviation 26.2	-8.8 scores on a scale Standard Deviation 25.8	-6.2 scores on a scale Standard Deviation 32.8	-6.2 scores on a scale Standard Deviation 26.1
Change in Bowel Function Index From Baseline to Day 15 Feeling of Incomplete Bowel Evacuation	-15.1 scores on a scale Standard Deviation 23.3	-9.5 scores on a scale Standard Deviation 34.0	-11.6 scores on a scale Standard Deviation 30.1	-10.9 scores on a scale Standard Deviation 31.5
Change in Bowel Function Index From Baseline to Day 15 Personal Judgement of Constipation	-5.7 scores on a scale Standard Deviation 20.9	-12.4 scores on a scale Standard Deviation 27.6	-10.1 scores on a scale Standard Deviation 27.3	-7.5 scores on a scale Standard Deviation 24.3

SECONDARY outcome

Timeframe: Baseline and Day 15

Population: The number of participants analysed is the number of participants who met the per protocol population requirement. 17 participants did not meet the per protocol compliance (must have consumed ≥80% of assigned study product and 100% of radio opaque pellets) and 2 participants did not complete the study (did not complete end-of-study visit).

Assessed using single question dichotomous tool. Adequate relief quantified the difference in the number of participants experiencing relief from constipation between participants supplemented with Litesse and those supplemented with a placebo at baseline and day 14. The units of analysis for the relief questionnaire were the number of participants who reported relief from constipation.

Outcome measures

Outcome measures
Measure	Litesse Powder Containing 4 g Polydextrose n=43 Participants 4 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 4 g polydextrose: 4 g polydextrose, 8 g maltodextrin	Placebo n=42 Participants Maltodextrin, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Placebo: 12 g Maltodextrin	Litesse Powder Containing 12 g Polydextrose n=45 Participants 12 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 12 g polydextrose: 12 g polydextrose	Litesse Powder Containing 8 g Polydextrose n=43 Participants 8 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 8 g polydextrose: 8 g polydextrose, 4 g maltodextrin
Change in Adequate Relief of Constipation Symptoms From Baseline to Day 15 Relief at Baseline	19 Participants	16 Participants	24 Participants	25 Participants
Change in Adequate Relief of Constipation Symptoms From Baseline to Day 15 Relief at Day 14 End-of-Study	20 Participants	26 Participants	36 Participants	31 Participants

SECONDARY outcome

Timeframe: 14 day run-in and Week 2 of the 14-day supplementation period

Population: The number of participants analysed is the number of participants who met the per protocol population requirement. 17 participants did not meet the per protocol compliance (must have consumed ≥80% of assigned study product and 100% of radio opaque pellets) and 2 participants did not complete the study (did not complete end-of-study visit).

Participants will record the number of defecations per day in a daily diary

Outcome measures

Outcome measures
Measure	Litesse Powder Containing 4 g Polydextrose n=43 Participants 4 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 4 g polydextrose: 4 g polydextrose, 8 g maltodextrin	Placebo n=42 Participants Maltodextrin, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Placebo: 12 g Maltodextrin	Litesse Powder Containing 12 g Polydextrose n=45 Participants 12 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 12 g polydextrose: 12 g polydextrose	Litesse Powder Containing 8 g Polydextrose n=43 Participants 8 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 8 g polydextrose: 8 g polydextrose, 4 g maltodextrin
Change in Stool Frequency From Baseline to Day 15	-0.4 Number of Bowel Movements Per Day Standard Deviation 2.2	-0.9 Number of Bowel Movements Per Day Standard Deviation 3.7	1.2 Number of Bowel Movements Per Day Standard Deviation 3.3	-0.2 Number of Bowel Movements Per Day Standard Deviation 3.3

SECONDARY outcome

Timeframe: 14 day run-in and Week 2 of the 14-day supplementation period

Population: The number of participants analysed is the number of participants who met the per protocol population requirement. 17 participants did not meet the per protocol compliance (must have consumed ≥80% of assigned study product and 100% of radio opaque pellets) and 2 participants did not complete the study (did not complete end-of-study visit).

Stool consistency will be rated each day in a diary by using the Bristol Stool Scale Form. Bristol Stool Scale: The BSS is a categorical scale ranging from 1 to 7 that interprets the consistency of a single bowel movement; a single score is recorded and used for analysis. Lower scores are associated with hard and lumpy consistencies while higher scores are associated with soft or liquid consistencies. Generally, an optimal BSS scores ranges from 3 to 5.

Outcome measures

Outcome measures
Measure	Litesse Powder Containing 4 g Polydextrose n=43 Participants 4 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 4 g polydextrose: 4 g polydextrose, 8 g maltodextrin	Placebo n=42 Participants Maltodextrin, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Placebo: 12 g Maltodextrin	Litesse Powder Containing 12 g Polydextrose n=45 Participants 12 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 12 g polydextrose: 12 g polydextrose	Litesse Powder Containing 8 g Polydextrose n=43 Participants 8 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 8 g polydextrose: 8 g polydextrose, 4 g maltodextrin
Change in Stool Consistency From Baseline to Day 15	0.30 scores on a scale Standard Deviation 0.99	0.13 scores on a scale Standard Deviation 0.93	0.33 scores on a scale Standard Deviation 0.99	-0.11 scores on a scale Standard Deviation 0.95

SECONDARY outcome

Timeframe: 14 day run-in and Week 2 of the 14-day supplementation period

Population: The number of participants analysed is the number of participants who met the per protocol population requirement. 17 participants did not meet the per protocol compliance (must have consumed ≥80% of assigned study product and 100% of radio opaque pellets) and 2 participants did not complete the study (did not complete end-of-study visit).

Degree of straining for each bowel movement will be recorded in a daily diary using a 5-point scale. The degree of straining is a rating scale ranging from 1 (not at al) to 5 (an extreme amount) that interprets the degree to which an individual must strain during a unique defecation; a single core is recorded and used for analysis. Scores were calculated as the weekly average of the daily degree of straining (1-5) where a lower score represented less straining.

Outcome measures

Outcome measures
Measure	Litesse Powder Containing 4 g Polydextrose n=43 Participants 4 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 4 g polydextrose: 4 g polydextrose, 8 g maltodextrin	Placebo n=42 Participants Maltodextrin, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Placebo: 12 g Maltodextrin	Litesse Powder Containing 12 g Polydextrose n=45 Participants 12 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 12 g polydextrose: 12 g polydextrose	Litesse Powder Containing 8 g Polydextrose n=43 Participants 8 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 8 g polydextrose: 8 g polydextrose, 4 g maltodextrin
Change in the Degree of Straining During Defecation From Baseline to Day 15	-0.15 scores on a scale Standard Deviation 0.81	-0.09 scores on a scale Standard Deviation 0.46	-0.07 scores on a scale Standard Deviation 0.82	-0.26 scores on a scale Standard Deviation 0.87

SECONDARY outcome

Timeframe: 14 day run-in and Week 2 of the 14-day supplementation period

Population: The number of participants analysed is the number of participants who met the per protocol population requirement. 17 participants did not meet the per protocol compliance (must have consumed ≥80% of assigned study product and 100% of radio opaque pellets) and 2 participants did not complete the study (did not complete end-of-study visit).

Sensation of complete bowel emptying for each bowel movement will be recorded in a daily diary on a dichotomous "yes" or "no" scale. The change in the sensation was defined as the change from baseline to week 2 in the percentage of complete bowel movements (CBMs) between participants supplemented with Litesse and those supplemented with a placebo. It assessed whether the participant felt as though their bowel movement was complete. The units of analysis for the sensation of complete bowel emptying was the weekly percentage of complete bowel movements, for each participant at run-in (week -1), week 1 and week 2.

Outcome measures

Outcome measures
Measure	Litesse Powder Containing 4 g Polydextrose n=43 Participants 4 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 4 g polydextrose: 4 g polydextrose, 8 g maltodextrin	Placebo n=42 Participants Maltodextrin, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Placebo: 12 g Maltodextrin	Litesse Powder Containing 12 g Polydextrose n=45 Participants 12 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 12 g polydextrose: 12 g polydextrose	Litesse Powder Containing 8 g Polydextrose n=43 Participants 8 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 8 g polydextrose: 8 g polydextrose, 4 g maltodextrin
Change in the Sensation of Complete Bowel Emptying From Baseline to Day 15	7.3 Percentage of CBMs per week Standard Deviation 31.3	-3.4 Percentage of CBMs per week Standard Deviation 33.2	10.8 Percentage of CBMs per week Standard Deviation 27.5	10.2 Percentage of CBMs per week Standard Deviation 25.1

SECONDARY outcome

Timeframe: 14 day run-in and Week 2 of the 14-day supplementation period

Population: The number of participants analysed is the number of participants who met the per protocol population requirement. 17 participants did not meet the per protocol compliance (must have consumed ≥80% of assigned study product and 100% of radio opaque pellets) and 2 participants did not complete the study (did not complete end-of-study visit).

Severity of abdominal discomfort will be recorded each day in a daily diary on a 5-point scale. The severity of abdominal discomfort was calculated from a rating scale ranging from 1 (not at all) to 5 very severe); a single score was recorded and used for analysis. Scores were calculated as the weekly average of the daily degree of discomfort where a lower score represented less straining.

Outcome measures

Outcome measures
Measure	Litesse Powder Containing 4 g Polydextrose n=43 Participants 4 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 4 g polydextrose: 4 g polydextrose, 8 g maltodextrin	Placebo n=42 Participants Maltodextrin, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Placebo: 12 g Maltodextrin	Litesse Powder Containing 12 g Polydextrose n=45 Participants 12 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 12 g polydextrose: 12 g polydextrose	Litesse Powder Containing 8 g Polydextrose n=43 Participants 8 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 8 g polydextrose: 8 g polydextrose, 4 g maltodextrin
Change in the Severity of Abdominal Discomfort From Baseline to Day 15	-0.10 scores on a scale Standard Deviation 0.58	-0.01 scores on a scale Standard Deviation 0.44	0.06 scores on a scale Standard Deviation 0.57	-0.05 scores on a scale Standard Deviation 0.61

SECONDARY outcome

Timeframe: 14 day run-in and Week 2 of the 14-day supplementation period

Population: The number of participants analysed is the number of participants who met the per protocol population requirement. 17 participants did not meet the per protocol compliance (must have consumed ≥80% of assigned study product and 100% of radio opaque pellets) and 2 participants did not complete the study (did not complete end-of-study visit).

Severity of bloating will be recorded each day in a daily diary on a 5-point scale. The severity of abdominal bloating was calculated from a rating scale ranging from 1 (not at all) to 5 very severe); a single score was recorded and used for analysis. Scores were calculated as the weekly average of the daily degree of bloating where a lower score represented less straining.

Outcome measures

Outcome measures
Measure	Litesse Powder Containing 4 g Polydextrose n=43 Participants 4 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 4 g polydextrose: 4 g polydextrose, 8 g maltodextrin	Placebo n=42 Participants Maltodextrin, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Placebo: 12 g Maltodextrin	Litesse Powder Containing 12 g Polydextrose n=45 Participants 12 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 12 g polydextrose: 12 g polydextrose	Litesse Powder Containing 8 g Polydextrose n=43 Participants 8 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks Litesse powder containing 8 g polydextrose: 8 g polydextrose, 4 g maltodextrin
Change in the Bloating Severity From Baseline to Day 15	-0.12 scores on a scale Standard Deviation 0.49	-0.03 scores on a scale Standard Deviation 0.58	-0.13 scores on a scale Standard Deviation 0.58	-0.23 scores on a scale Standard Deviation 0.47

SECONDARY outcome

Timeframe: Assessed at Day 15 (end of study)

Population: The number of participants analysed is the number of participants who met the per protocol population requirement. 17 participants did not meet the per protocol compliance (must have consumed ≥80% of assigned study product and 100% of radio opaque pellets) and 2 participants did not complete the study (did not complete end-of-study visit).

Participants will be asked to rate their overall satisfaction with the study product's ability to relieve their constipation symptoms on a 5-point ordinal scale. The overall product satisfaction questionnaire consists of a single question that provides insight regarding the participants satisfaction on the product's ability to relieve constipation symptoms. The score that the participant indicates is considered the total score and no sub-scores are calculated. It is a rating scale that ranges from 1 (not at all satisfied) to 5 (very satisfied) where a higher score at the end-of-study indicates an improvement.