Last updated: 01/24/2024 07:00:36
An Exploratory Study to Measure the Effect of Two Dietary Fibers on Satiety and Glycemic Parameters
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: An Exploratory Study to Measure the Effect of Two Dietary Fibers on Satiety and Glycemic Parameters
Trial description: This study will examine whether dietary supplementation with a combination of two dietary fibers will produce greater changes from baseline compared to control for satiety and glycemic parameters. Two strength levels (“high” and “low”) of the combination of dietary fibers will be tested.
Primary purpose:
Not applicable
Trial design:
Parallel Assignment
Masking:
Single (Investigator)
Allocation:
Randomized
Primary outcomes:
reductions energy intake from baseline
Timeframe: Basline, Visit 2 and Visit 3 (3 weeks total)
Secondary outcomes:
Glucose and Insulin Levels
Timeframe: Baseline, Visit 2 & Visit 3
Fasting Glycemic Parameters (glucose and insulin)
Timeframe: Baseline, Visit 2 & Visit 3
Subjective Appetite Ratings (SLIM Scale)
Timeframe: Baseline, Visit 2 & Visit 3
Body Weight
Timeframe: Baseline, Visit 2 & Visit 3
Interventions:
Dietary: dietary fiber
Dietary: Placebo
Enrollment:
96
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
body weight
Product
Oligofructose, Pectin
Collaborators
Not applicable
Study date(s)
October 2011 to December 2011
Type
Interventional
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
18 - 60 Year
Accepts healthy volunteers
yes
- Male and female subjects aged 18-60 years, in good general health with a BMI 25- <35 kg/m2 will be eligible. Subjects will also be required to meet the following criteria: non-smoker, non-dieting, and regularly consuming 3 main meals a day. Subjects must be free from significant food restrictions and willing and able to comply with the study protocol including consumption of food items provided at the clinic visits.
Inclusion and exclusion criteria
Inclusion criteria:
- Male and female subjects aged 18-60 years, in good general health with a BMI 25- <35 kg/m2 will be eligible. Subjects will also be required to meet the following criteria: non-smoker, non-dieting, and regularly consuming 3 main meals a day. Subjects must be free from significant food restrictions and willing and able to comply with the study protocol including consumption of food items provided at the clinic visits.
Trial location(s)
No location data available.
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Completed
Actual primary completion date
Not applicable
Actual study completion date
Not applicable
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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