Trial Outcomes & Findings for Effect of Oligofructose on Appetite in Overweight Subjects (NCT NCT00912197)

Results Overview

Hunger was assessed by visual analogue scales (Each scale is 10cm in length with words anchored at each end, expressing the most positive (Minimum score = 0 cm and means no hunger) and the most negative rating (Maximum score = 10 cm and means very hungry). Compared to baseline after treatment at 56 days

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

28 participants

Primary outcome timeframe

Baseline, 56 days

Results posted on

2021-01-14

Participant Flow

Participant milestones

Participant milestones
Measure	Oligofructose Participants consumed 30g of oligofructose daily for 6 weeks after a 2-weeks run-in.	Cellulose and Maltodextrin Placebo: Participants consumed 3 doses (a total of 30g dietary fibres) product daily for six weeks after a 2-week run-in
Overall Study STARTED	15	13
Overall Study COMPLETED	12	10
Overall Study NOT COMPLETED	3	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Oligofructose Participants consumed 30g of oligofructose daily for 6 weeks after a 2-weeks run-in.	Cellulose and Maltodextrin Placebo: Participants consumed 3 doses (a total of 30g dietary fibres) product daily for six weeks after a 2-week run-in
Overall Study Withdrawal by Subject	3	3

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Oligofructose n=12 Participants Participants consumed 30g of oligofructose daily for 6 weeks after a 2-weeks run-in.	Cellulose and Maltodextrin n=10 Participants Placebo: Participants consumed 3 doses (a total of 30g dietary fibres) product daily for six weeks after a 2-week run-in	Total n=22 Participants Total of all reporting groups
Age, Continuous	36.5 years STANDARD_DEVIATION 2.2 • n=12 Participants	28.7 years STANDARD_DEVIATION 2.3 • n=10 Participants	32 years STANDARD_DEVIATION 2 • n=22 Participants
Sex: Female, Male Female	9 Participants n=12 Participants	7 Participants n=10 Participants	16 Participants n=22 Participants
Sex: Female, Male Male	3 Participants n=12 Participants	3 Participants n=10 Participants	6 Participants n=22 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United Kingdom	12 participants n=12 Participants	10 participants n=10 Participants	22 participants n=22 Participants
BMI	29.7 kg/m^2 STANDARD_DEVIATION 1.0 • n=12 Participants	31.1 kg/m^2 STANDARD_DEVIATION 1.1 • n=10 Participants	30.5 kg/m^2 STANDARD_DEVIATION 1.1 • n=22 Participants
waist:hip ratio (WHR)	0.86 ratio STANDARD_DEVIATION 0.03 • n=12 Participants	0.82 ratio STANDARD_DEVIATION 0.02 • n=10 Participants	0.84 ratio STANDARD_DEVIATION 0.02 • n=22 Participants

PRIMARY outcome

Timeframe: Baseline, 56 days

Hunger was assessed by visual analogue scales (Each scale is 10cm in length with words anchored at each end, expressing the most positive (Minimum score = 0 cm and means no hunger) and the most negative rating (Maximum score = 10 cm and means very hungry). Compared to baseline after treatment at 56 days

Outcome measures

Outcome measures
Measure	Oligofructose n=12 Participants Participants consumed 30g of oligofructose daily for 6 weeks after a 2-weeks run-in.	Cellulose and Maltodextrin n=10 Participants Placebo: Participants consumed 3 doses (a total of 30g dietary fibres) product daily for six weeks after a 2-week run-in
Subjective Appetite Ratings in Hunger Compared to Baseline baseline	4.8 cm Standard Error 0.9	3.6 cm Standard Error 0.8
Subjective Appetite Ratings in Hunger Compared to Baseline 56 days	3.6 cm Standard Error 0.8	4.1 cm Standard Error 0.6

PRIMARY outcome

Timeframe: Baseline, 56 days

Fullness are assessed by visual analogue scale, 10 cm in length with words anchored at each end, expressing the most positive (feel full: maximum Score=10cm) and the most negative rating (feeling empty: Minimum Score = 0cm), values at baseline and after treatments at 56 days

Outcome measures

Outcome measures
Measure	Oligofructose n=12 Participants Participants consumed 30g of oligofructose daily for 6 weeks after a 2-weeks run-in.	Cellulose and Maltodextrin n=10 Participants Placebo: Participants consumed 3 doses (a total of 30g dietary fibres) product daily for six weeks after a 2-week run-in
Subjective Appetite Ratings in Fullness Compared to Baseline Baseline	4.7 units on a scale Standard Error 0.5	4.2 units on a scale Standard Error 0.8
Subjective Appetite Ratings in Fullness Compared to Baseline 56 days	4.2 units on a scale Standard Error 0.8	4.1 units on a scale Standard Error 0.6

PRIMARY outcome

Timeframe: Baseline, 56 days

Outcome measures

Outcome measures
Measure	Oligofructose n=12 Participants Participants consumed 30g of oligofructose daily for 6 weeks after a 2-weeks run-in.	Cellulose and Maltodextrin n=10 Participants Placebo: Participants consumed 3 doses (a total of 30g dietary fibres) product daily for six weeks after a 2-week run-in
Body Weight Baseline	83.7 kg Standard Error 4.9	86 kg Standard Error 4.4
Body Weight 56 days	84.1 kg Standard Error 4.8	86.3 kg Standard Error 4.5

PRIMARY outcome

Timeframe: Baseline, 56 days

Energy intake was assessed by 7-days food diary at baseline and last week of treatment, diaries were analysed by Dietplan6 software. The values in the table represent the Energy intake as measured over the whole week (as opposed to reporting the Energy intake per day based on the 7 day data).

Outcome measures

Outcome measures
Measure	Oligofructose n=12 Participants Participants consumed 30g of oligofructose daily for 6 weeks after a 2-weeks run-in.	Cellulose and Maltodextrin n=10 Participants Placebo: Participants consumed 3 doses (a total of 30g dietary fibres) product daily for six weeks after a 2-week run-in
Energy Intake Baseline	873.16 kcal Standard Error 54.06	867.61 kcal Standard Error 159.45
Energy Intake 56 days	760.19 kcal Standard Error 51.59	725.34 kcal Standard Error 117.40

PRIMARY outcome

Timeframe: baseline (Day 0) and post-supplementation (Day 56)

Population: The PI has left the institution. There is no access to the raw data, we only have access to the graphical data in publication (please see: Daud NM, Ismail NA, Thomas EL, Fitzpatrick JA, Bell JD, Swann JR, Costabile A, Childs CE, Pedersen C, Goldstone AP, Frost GS. The impact of oligofructose on stimulation of gut hormones, appetite regulation and adiposity. Obesity (Silver Spring). 2014 Jun;22(6):1430-8. doi: 10.1002/oby.20754. Epub 2014 Apr 8. PubMed ID: 24715424 for graph)

Total PYY concentrations were quantified using specific and sensitive in-house radio-immunoassays as previously described.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, 56 days

Body composition assessed by BMI

Outcome measures

Outcome measures
Measure	Oligofructose n=12 Participants Participants consumed 30g of oligofructose daily for 6 weeks after a 2-weeks run-in.	Cellulose and Maltodextrin n=10 Participants Placebo: Participants consumed 3 doses (a total of 30g dietary fibres) product daily for six weeks after a 2-week run-in
Body Composition Baseline	29.7 kg/m^2 Standard Error 1.0	31.1 kg/m^2 Standard Error 1.1
Body Composition 56 days	29.9 kg/m^2 Standard Error 1.1	31.2 kg/m^2 Standard Error 1.1

SECONDARY outcome

Timeframe: Baseline, 56 days

Total adipose tissue was assessed by FMRI at baseline and after treatment period

Outcome measures

Outcome measures
Measure	Oligofructose n=12 Participants Participants consumed 30g of oligofructose daily for 6 weeks after a 2-weeks run-in.	Cellulose and Maltodextrin n=10 Participants Placebo: Participants consumed 3 doses (a total of 30g dietary fibres) product daily for six weeks after a 2-week run-in
Imaging of Total Adipose Tissue 56 days	37 percentage of body fat Standard Error 2.8	38.7 percentage of body fat Standard Error 3.8
Imaging of Total Adipose Tissue Baseline	36.3 percentage of body fat Standard Error 2.8	38.4 percentage of body fat Standard Error 3.7

SECONDARY outcome

Timeframe: Baseline, 56 days

Short-chain fatty acids (acetate, propionate, butyrate) concentrations assessed from plasma at 56 days at 450min timepoint with gas chromatography

Outcome measures

Outcome measures
Measure	Oligofructose n=12 Participants Participants consumed 30g of oligofructose daily for 6 weeks after a 2-weeks run-in.	Cellulose and Maltodextrin n=10 Participants Placebo: Participants consumed 3 doses (a total of 30g dietary fibres) product daily for six weeks after a 2-week run-in
Plasma Short-chain Fatty Acids Concentrations After Treatment Acetate	81.3 uM Standard Error 2.1	72.8 uM Standard Error 1.8
Plasma Short-chain Fatty Acids Concentrations After Treatment Propionate	5.4 uM Standard Error 0.6	5.4 uM Standard Error 0.6
Plasma Short-chain Fatty Acids Concentrations After Treatment Butyrate	0.9 uM Standard Error 0.1	0.7 uM Standard Error 0.2

SECONDARY outcome

Timeframe: baseline (Day 0) and post-supplementation (Day 56)

Population: Inflammatory markers where never measured for this study and so therefore no results available.

No data were collected for this Outcome Measure

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: baseline (Day 0) and post-supplementation (Day 56)

Glucose was analyzed in the Department of Clinical Biochemistry, Hammer-smith Hospital, London using an Abbott Architect ci8200 analyzer(Abbott Diagnostics, Maidenhead, UK).

Outcome measures

Outcome measures
Measure	Oligofructose n=12 Participants Participants consumed 30g of oligofructose daily for 6 weeks after a 2-weeks run-in.	Cellulose and Maltodextrin n=10 Participants Placebo: Participants consumed 3 doses (a total of 30g dietary fibres) product daily for six weeks after a 2-week run-in
Glycemic Response	4.8 mmol/L Interval 4.6 to 5.0	4.7 mmol/L Interval 4.5 to 5.0

SECONDARY outcome

Timeframe: baseline (Day 0) and post-supplementation (Day 56)

Plasma insulin concentrations were assayed using RIA kits (Millipore, MO).

Outcome measures

Outcome measures
Measure	Oligofructose n=12 Participants Participants consumed 30g of oligofructose daily for 6 weeks after a 2-weeks run-in.	Cellulose and Maltodextrin n=10 Participants Placebo: Participants consumed 3 doses (a total of 30g dietary fibres) product daily for six weeks after a 2-week run-in
Serum Insulin	10.2 (mU/L Interval 8.7 to 12.0	9.6 (mU/L Interval 6.4 to 15.6

SECONDARY outcome

Timeframe: baseline (Day 0) and post-supplementation (Day 56)

Population: The PI has left the institution. There is no access to the raw data, we only have access to the graphical data in publication (please see: Daud NM, Ismail NA, Thomas EL, Fitzpatrick JA, Bell JD, Swann JR, Costabile A, Childs CE, Pedersen C, Goldstone AP, Frost GS. The impact of oligofructose on stimulation of gut hormones, appetite regulation and adiposity. Obesity (Silver Spring). 2014 Jun;22(6):1430-8. doi: 10.1002/oby.20754. Epub 2014 Apr 8. PubMed ID: 24715424 for graph)

breath hydrogen were obtained from volunteers throughout the study session.

Outcome measures

Outcome data not reported

Adverse Events

Oligofructose

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Cellulose and Maltodextrin

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Prof Gary Frost

Imperial College London

Phone: +44 (0)20 7594 0959

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place