Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effect of Oligofructose on Appetite in Overweight Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00912197
Recruitment Status : Completed
First Posted : June 3, 2009
Results First Posted : December 30, 2020
Last Update Posted : January 14, 2021
Sponsor:
Information provided by (Responsible Party):
Imperial College London

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Other
Conditions Appetite Regulation
Obesity
Interventions Dietary Supplement: Oligofructose
Dietary Supplement: Placebo
Enrollment 28
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Oligofructose Cellulose and Maltodextrin
Hide Arm/Group Description Participants consumed 30g of oligofructose daily for 6 weeks after a 2-weeks run-in. Placebo: Participants consumed 3 doses (a total of 30g dietary fibres) product daily for six weeks after a 2-week run-in
Period Title: Overall Study
Started 15 13
Completed 12 10
Not Completed 3 3
Reason Not Completed
Withdrawal by Subject             3             3
Arm/Group Title Oligofructose Cellulose and Maltodextrin Total
Hide Arm/Group Description Participants consumed 30g of oligofructose daily for 6 weeks after a 2-weeks run-in. Placebo: Participants consumed 3 doses (a total of 30g dietary fibres) product daily for six weeks after a 2-week run-in Total of all reporting groups
Overall Number of Baseline Participants 12 10 22
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 12 participants 10 participants 22 participants
36.5  (2.2) 28.7  (2.3) 32  (2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 10 participants 22 participants
Female
9
  75.0%
7
  70.0%
16
  72.7%
Male
3
  25.0%
3
  30.0%
6
  27.3%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants
0
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United Kingdom Number Analyzed 12 participants 10 participants 22 participants
12 10 22
BMI  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 12 participants 10 participants 22 participants
29.7  (1.0) 31.1  (1.1) 30.5  (1.1)
waist:hip ratio (WHR)  
Mean (Standard Deviation)
Unit of measure:  Ratio
Number Analyzed 12 participants 10 participants 22 participants
0.86  (0.03) 0.82  (0.02) 0.84  (0.02)
1.Primary Outcome
Title Subjective Appetite Ratings in Hunger Compared to Baseline
Hide Description 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
Time Frame Baseline, 56 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Oligofructose Cellulose and Maltodextrin
Hide Arm/Group Description:
Participants consumed 30g of oligofructose daily for 6 weeks after a 2-weeks run-in.
Placebo: Participants consumed 3 doses (a total of 30g dietary fibres) product daily for six weeks after a 2-week run-in
Overall Number of Participants Analyzed 12 10
Mean (Standard Error)
Unit of Measure: cm
baseline 4.8  (0.9) 3.6  (0.8)
56 days 3.6  (0.8) 4.1  (0.6)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Oligofructose, Cellulose and Maltodextrin
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.135
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
2.Primary Outcome
Title Subjective Appetite Ratings in Fullness Compared to Baseline
Hide Description 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
Time Frame Baseline, 56 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Oligofructose Cellulose and Maltodextrin
Hide Arm/Group Description:
Participants consumed 30g of oligofructose daily for 6 weeks after a 2-weeks run-in.
Placebo: Participants consumed 3 doses (a total of 30g dietary fibres) product daily for six weeks after a 2-week run-in
Overall Number of Participants Analyzed 12 10
Mean (Standard Error)
Unit of Measure: units on a scale
Baseline 4.7  (0.5) 4.2  (0.8)
56 days 4.2  (0.8) 4.1  (0.6)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Oligofructose, Cellulose and Maltodextrin
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.688
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
3.Primary Outcome
Title Body Weight
Hide Description [Not Specified]
Time Frame Baseline, 56 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Oligofructose Cellulose and Maltodextrin
Hide Arm/Group Description:
Participants consumed 30g of oligofructose daily for 6 weeks after a 2-weeks run-in.
Placebo: Participants consumed 3 doses (a total of 30g dietary fibres) product daily for six weeks after a 2-week run-in
Overall Number of Participants Analyzed 12 10
Mean (Standard Error)
Unit of Measure: kg
Baseline 83.7  (4.9) 86  (4.4)
56 days 84.1  (4.8) 86.3  (4.5)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Oligofructose, Cellulose and Maltodextrin
Comments after treatment, 56 days
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.715
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
4.Primary Outcome
Title Energy Intake
Hide Description

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).
Time Frame Baseline, 56 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Oligofructose Cellulose and Maltodextrin
Hide Arm/Group Description:
Participants consumed 30g of oligofructose daily for 6 weeks after a 2-weeks run-in.
Placebo: Participants consumed 3 doses (a total of 30g dietary fibres) product daily for six weeks after a 2-week run-in
Overall Number of Participants Analyzed 12 10
Mean (Standard Error)
Unit of Measure: kcal
Baseline 873.16  (54.06) 867.61  (159.45)
56 days 760.19  (51.59) 725.34  (117.40)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Oligofructose, Cellulose and Maltodextrin
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.578
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Oligofructose
Comments baseline to after treatment, at 56 days
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.007
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Cellulose and Maltodextrin
Comments baseline to after treatment, at 56 days
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.05
Comments calculated
Method t-test, 2 sided
Comments [Not Specified]
5.Primary Outcome
Title Gut Hormone PYY
Hide Description Total PYY concentrations were quantified using specific and sensitive in-house radio-immunoassays as previously described.
Time Frame baseline (Day 0) and post-supplementation (Day 56)
Hide Outcome Measure Data
Hide Analysis Population Description
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)
Arm/Group Title Oligofructose Cellulose and Maltodextrin
Hide Arm/Group Description:

Participants received 10g of Oligofructose powdered supplements in sachets each containing 10 g dietary fiber) three times per day. Volunteers were instructed to take the supplement with their main meals.The 8-week supplementation period took place between visits 3 and 4 and included a 2-week run-in period to allow the bowel to adapt to the 30 g of dietary fiber.

Oligofructose: Participants will be asked to consume 30g of oligofructose daily for six weeks after a 2-week run-in.

Participants received 10g of Cellulose powdered supplements in sachets each containing 10 g dietary fiber) three times per day. Volunteers were instructed to take the supplement with their main meals. Maltodextrin was added to the cellulose supplement. The 8-week supplementation period took place between visits 3 and 4 and included a 2-week run-in period to allow the bowel to adapt to the 30 g of dietary fiber.

Placebo: Participants will be asked to consume 3 doses (a total of 30g dietary fibres) of the placebo product daily for six weeks after a 2-week run-in
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
6.Secondary Outcome
Title Body Composition
Hide Description Body composition assessed by BMI
Time Frame Baseline, 56 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Oligofructose Cellulose and Maltodextrin
Hide Arm/Group Description:
Participants consumed 30g of oligofructose daily for 6 weeks after a 2-weeks run-in.
Placebo: Participants consumed 3 doses (a total of 30g dietary fibres) product daily for six weeks after a 2-week run-in
Overall Number of Participants Analyzed 12 10
Mean (Standard Error)
Unit of Measure: kg/m^2
Baseline 29.7  (1.0) 31.1  (1.1)
56 days 29.9  (1.1) 31.2  (1.1)
7.Secondary Outcome
Title Imaging of Total Adipose Tissue
Hide Description Total adipose tissue was assessed by FMRI at baseline and after treatment period
Time Frame Baseline, 56 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Oligofructose Cellulose and Maltodextrin
Hide Arm/Group Description:
Participants consumed 30g of oligofructose daily for 6 weeks after a 2-weeks run-in.
Placebo: Participants consumed 3 doses (a total of 30g dietary fibres) product daily for six weeks after a 2-week run-in
Overall Number of Participants Analyzed 12 10
Mean (Standard Error)
Unit of Measure: percentage of body fat
Baseline 36.3  (2.8) 38.4  (3.7)
56 days 37  (2.8) 38.7  (3.8)
8.Secondary Outcome
Title Plasma Short-chain Fatty Acids Concentrations After Treatment
Hide Description Short-chain fatty acids (acetate, propionate, butyrate) concentrations assessed from plasma at 56 days at 450min timepoint with gas chromatography
Time Frame Baseline, 56 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Oligofructose Cellulose and Maltodextrin
Hide Arm/Group Description:
Participants consumed 30g of oligofructose daily for 6 weeks after a 2-weeks run-in.
Placebo: Participants consumed 3 doses (a total of 30g dietary fibres) product daily for six weeks after a 2-week run-in
Overall Number of Participants Analyzed 12 10
Mean (Standard Error)
Unit of Measure: uM
Acetate 81.3  (2.1) 72.8  (1.8)
Propionate 5.4  (0.6) 5.4  (0.6)
Butyrate 0.9  (0.1) 0.7  (0.2)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Oligofructose, Cellulose and Maltodextrin
Comments Acetate
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.024
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
9.Secondary Outcome
Title Inflammatory Markers
Hide Description No data were collected for this Outcome Measure
Time Frame baseline (Day 0) and post-supplementation (Day 56)
Hide Outcome Measure Data
Hide Analysis Population Description
Inflammatory markers where never measured for this study and so therefore no results available.
Arm/Group Title Oligofructose Cellulose and Maltodextrin
Hide Arm/Group Description:
Participants consumed 30g of oligofructose daily for 6 weeks after a 2-weeks run-in.
Placebo: Participants consumed 3 doses (a total of 30g dietary fibres) product daily for six weeks after a 2-week run-in
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
10.Secondary Outcome
Title Glycemic Response
Hide Description Glucose was analyzed in the Department of Clinical Biochemistry, Hammer-smith Hospital, London using an Abbott Architect ci8200 analyzer(Abbott Diagnostics, Maidenhead, UK).
Time Frame baseline (Day 0) and post-supplementation (Day 56)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Oligofructose Cellulose and Maltodextrin
Hide Arm/Group Description:
Participants consumed 30g of oligofructose daily for 6 weeks after a 2-weeks run-in.
Placebo: Participants consumed 3 doses (a total of 30g dietary fibres) product daily for six weeks after a 2-week run-in
Overall Number of Participants Analyzed 12 10
Mean (95% Confidence Interval)
Unit of Measure: mmol/L
4.8
(4.6 to 5.0)
4.7
(4.5 to 5.0)
11.Secondary Outcome
Title Serum Insulin
Hide Description Plasma insulin concentrations were assayed using RIA kits (Millipore, MO).
Time Frame baseline (Day 0) and post-supplementation (Day 56)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Oligofructose Cellulose and Maltodextrin
Hide Arm/Group Description:
Participants consumed 30g of oligofructose daily for 6 weeks after a 2-weeks run-in.
Placebo: Participants consumed 3 doses (a total of 30g dietary fibres) product daily for six weeks after a 2-week run-in
Overall Number of Participants Analyzed 12 10
Mean (95% Confidence Interval)
Unit of Measure: (mU/L
10.2
(8.7 to 12)
9.6
(6.4 to 15.6)
12.Secondary Outcome
Title Breath Hydrogen Levels
Hide Description breath hydrogen were obtained from volunteers throughout the study session.
Time Frame baseline (Day 0) and post-supplementation (Day 56)
Hide Outcome Measure Data
Hide Analysis Population Description
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)
Arm/Group Title Oligofructose Cellulose and Maltodextrin
Hide Arm/Group Description:
Participants consumed 30g of oligofructose daily for 6 weeks after a 2-weeks run-in.
Placebo: Participants consumed 3 doses (a total of 30g dietary fibres) product daily for six weeks after a 2-week run-in
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame 56 days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Oligofructose Cellulose and Maltodextrin
Hide Arm/Group Description Participants consumed 30g of oligofructose daily for 6 weeks after a 2-weeks run-in. Placebo: Participants consumed 3 doses (a total of 30g dietary fibres) product daily for six weeks after a 2-week run-in
All-Cause Mortality
Oligofructose Cellulose and Maltodextrin
Affected / at Risk (%) Affected / at Risk (%)
Total   0/12 (0.00%)   0/10 (0.00%) 
Hide Serious Adverse Events
Oligofructose Cellulose and Maltodextrin
Affected / at Risk (%) Affected / at Risk (%)
Total   0/12 (0.00%)   0/10 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Oligofructose Cellulose and Maltodextrin
Affected / at Risk (%) Affected / at Risk (%)
Total   0/12 (0.00%)   0/10 (0.00%) 
[Not Specified]
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Prof Gary Frost
Organization: Imperial College London
Phone: +44 (0)20 7594 0959
EMail: g.frost@imperial.ac.uk
Publications of Results:
Pedersen C, Lefevre S, Peters V, Patterson M, Ghatei MA, Morgan LM, Frost GS. Gut hormone release and appetite regulation in healthy non-obese participants following oligofructose intake. A dose-escalation study. Appetite. 2013 Jul;66:44-53. doi: 10.1016/j.appet.2013.02.017. Epub 2013 Mar 5.
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.
Layout table for additonal information
Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT00912197    
Other Study ID Numbers: CRO1243
First Submitted: June 2, 2009
First Posted: June 3, 2009
Results First Submitted: October 24, 2019
Results First Posted: December 30, 2020
Last Update Posted: January 14, 2021