Effect of Oligofructose on Appetite in Overweight Subjects
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ClinicalTrials.gov Identifier: NCT00912197 |
Recruitment Status :
Completed
First Posted : June 3, 2009
Results First Posted : December 30, 2020
Last Update Posted : January 14, 2021
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Sponsor:
Imperial College London
Information provided by (Responsible Party):
Imperial College London
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Study Type | Interventional |
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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 |
Participant Flow
Recruitment Details | |
Pre-assignment Details |
Arm/Group Title | Oligofructose | Cellulose and Maltodextrin |
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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 |
Baseline Characteristics
Arm/Group Title | Oligofructose | Cellulose and Maltodextrin | Total | |
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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 | |
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[Not Specified]
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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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 |
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Number Analyzed | 12 participants | 10 participants | 22 participants | |
Female |
9 75.0%
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7 70.0%
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16 72.7%
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Male |
3 25.0%
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3 30.0%
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6 27.3%
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Race and Ethnicity Not Collected
[1] Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 0 participants | 0 participants | 0 participants | |
0 | ||||
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
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United Kingdom | Number Analyzed | 12 participants | 10 participants | 22 participants |
12 | 10 | 22 | ||
BMI
Mean (Standard Deviation) Unit of measure: Kg/m^2 |
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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 |
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Number Analyzed | 12 participants | 10 participants | 22 participants | |
0.86 (0.03) | 0.82 (0.02) | 0.84 (0.02) |
Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Results Point of Contact
Name/Title: | Prof Gary Frost |
Organization: | Imperial College London |
Phone: | +44 (0)20 7594 0959 |
EMail: | g.frost@imperial.ac.uk |
Publications of Results:
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 |