HealthyNCT04515277
Study to Evaluate the Effect of Gum Acacia (FibregumTM) on Post-prandial Glucose, Insulin Levels and Food Intake
A study testing 40 g Gum acacia (FibregumTM), 20 g Gum acacia (FibregumTM) and 0 g Gum acacia (FibregumTM) in people with Healthy and Overweight, run by Nexira at 1 site in Germany.
Trial summary
Study to evaluate the effect of gum acacia (FibregumTM) on post-prandial glucose and insulin levels and food intake in normal-weight and overweight subjects during a 2-7 weeks intervention period. In addition, tolerability and safety of gum acacia (FibregumTM) will be assessed. Read more about this study
- Who is it for?
- Ages 25 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Overweight
- What is being tested?
- 40 g Gum acacia (FibregumTM), 20 g Gum acacia (FibregumTM) and 0 g Gum acacia (FibregumTM)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteGermany
- Study dates
- 28 Jun 2019to 27 Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Men and women from 25 to 60 years old
- Body mass index (BMI) 18.5 kg/m2 - 29.9 kg/m2
- Generally in good health
- Normal fasting blood glucose (FBG) 3.9 to <5.6 mmol/L (70 to <100 mg/dL) and HbA1c of 4 to <5.7 %
- Regularly consuming 3 main meals/day, with breakfast and lunch as dominant meals
- Familiar with components of the study meals, no disliking and/or extreme preferences for any of the items
Show all 16Show fewer
- Readiness to comply with study procedures, in particular:
- adhere to the defined restrictions prior to / procedures on the test days
- maintain the habitual level of physical activity and sleep habits during the study
- fill out the study diary
- Stable body weight in the last 3 months prior to V1 (≤3% self-reported change)
- Stable concomitant medications (if any) for at least last 3 months prior to V1
- Women of childbearing potential:
- commitment to use contraception methods
- negative pregnancy testing (beta human chorionic gonadotropin test in urine) at V1
- Readiness not to participate in another clinical study during this study
Who cannot join
- Known allergy or hypersensitivity to the components of the investigational product / study meals
- History and/or presence of clinically significant self-reported disorder as per investigator's judgement:
- untreated or non-stabilized thyroid gland disorder
- untreated or non-stabilized hypertension (regular systolic blood pressure ≥ 140 mmHg and/or diastolic blood pressure ≥ 90 mmHg)
- digestion/absorption disorders of the gastrointestinal tract (e.g. inflammatory bowel disease, coeliac disease, pancreatitis etc.) and/or GI surgery
- diabetes mellitus
Show all 27Show fewer
- sleep disorder
- acute or chronic psychiatric disorder
- any other organ or systemic diseases that could influence the conduct and/or outcome of the study and/or could affect the tolerability of the subject
- Subjects with difficult vein access or sensitive to blood draws
- Nighttime eating/snacking (after 10 pm)
- Excessive consumption of artificial sweeteners (e.g. in beverages)
- History and/or presence of eating disorders like bulimia, anorexia nervosa, binge-eating as per investigator's judgement
- Use of treatment/supplementation in the last 2 months prior to V1 and during the study, as per investigator's judgment, that could influence gastrointestinal functions, body weight, blood glucose levels or otherwise interfere with study conduct / evaluation
- Deviation of safety laboratory parameter(s) at V1 (except for Hb and HbA1c) that is:
- clinically significant or
- >2x upper limit of normal, unless the deviation is justified by a previously known not clinically relevant condition (e.g. Gilbert's syndrome)
- Diet/weight loss programs within the last 3 months prior to V1 and during the study
- Recent blood donation within the last 1 month prior to study
- Smoking within the last 6 months prior to V1 and during the study
- Vegetarian, vegan or other restrictive diet
- Night shift work
- History or current abuse of alcohol, drug and/or medication
- Women of child-bearing potential: pregnancy or nursing
- Inability to comply with study procedures
- Participation in another study during the last 30 days prior to V1
- Any other reason deemed suitable for exclusion, per investigator's judgment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Double-blind, Randomized, Controlled, Three-way Cross-over Study to Evaluate the Effect of Gum Acacia (FibregumTM) on Post-prandial Glucose and Insulin Levels and Food Intake
Study to evaluate the effect of gum acacia (FibregumTM) on post-prandial glucose and insulin levels and food intake in normal-weight and overweight subjects during a 2-7 weeks intervention period. In addition, tolerability and safety of gum acacia (FibregumTM) will be assessed.
Read the detailed description
Gum arabic is a heteropolysaccharide (molecular weight 350-850 kDa) harvested from Acacia seyal or Acacia senegal. It is highly soluble and broadly used in numerous solid and liquid food matrices.
For the assessment of non-digestible carbohydrates as dietary fiber, it is eminent to demonstrate that its consumption is related to a specific beneficial physiological effect shown in an appropriate clinical study. The aim of the present trial was to expand the clinical evidence with respect to beneficial effects of gum acacia on post-prandial blood glucose levels, post-prandial insulin levels and prospective ad libitum food intake, in normal-weight and overweight subjects.
The present double-blind, randomized, controlled, three-way cross-over study was to evaluate the effect of gum acacia versus no treatment on post-prandial glucose (PPG) levels in normal-weight and overweight subjects during a 2-7 weeks intervention period.
Additionally, post-prandial insulin (PPI) levels, prospective ad libitum food intake, as well as the safety and tolerability of gum acacia were assessed.
- Conditions
- Healthy, Overweight
- Being tested
- 40 g Gum acacia (FibregumTM), 20 g Gum acacia (FibregumTM), 0 g Gum acacia (FibregumTM)
- Keywords
- gum acacia, post-prandial glucose (PPG), post-prandial insulin (PPI), blood glucose incremental, appetite sensation, E 414, food additive, FibregumTM, appetite, dietary fibre
- Medical subject headings
- Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
40 g Gum acacia (FibregumTM)Dietary supplement
Also called D1
Applied in 300 mL of orange juice with breakfast (single use at visit)
20 g Gum acacia (FibregumTM)Dietary supplement
Also called D2
Applied in 300 mL of orange juice with breakfast (single use at visit)
0 g Gum acacia (FibregumTM)Dietary supplement
Also called no treatment
300 mL of orange juice with breakfast (single use at visit)
| Study group | Role | What they receive |
|---|---|---|
| 40 g (D1) | Active comparator | 40 g gum acacia powder (D1). Treatment type is applied with the standardized breakfast (in 300 mL orange juice) on the test days (V2, V3 or V4). Receives: Dietary Supplement: 40 g Gum acacia (FibregumTM) |
| 20 g (D2) | Active comparator | 20 g gum acacia powder (D2). Treatment type is applied with the standardized breakfast (in 300 mL orange juice) on the test days (V2, V3 or V4). Receives: Dietary Supplement: 20 g Gum acacia (FibregumTM) |
| No treatment (NT) | Other | 0 g gum acacia powder. Standardized breakfast (in 300 mL orange juice) on the test days (V2, V3 or V4). Receives: Dietary Supplement: 0 g Gum acacia (FibregumTM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in blood glucose incremental AUC 0-120 min between D1 verum group and no treatment group
Venous blood samples were drawn for the determination of glucose values, with sampling times at -15 min and immediately prior to the intake of the standardized breakfast (time "0") as well as 15, 30, 45, 60, 90 and 120 min after the "0 min" blood draw.
Measured: 2 -7 weeks
Secondary outcomes (20)
Difference in blood glucose incremental AUC 0-120 min between D2 verum group and no treatment group
Venous blood samples were drawn for the determination of glucose values, with sampling times at -15 min and immediately prior to the intake of the standardized breakfast (time "0") as well as 15, 30, 45, 60, 90 and 120 min after the "0 min" blood draw.
Measured: 2 -7 weeks
Food (energy) intake at ad libitum lunch, in comparison between each verum group vs no treatment group
Food was weighed before the subject consumed the meal and afterwards and the energy content of the food consumed was determined.
Measured: 2 -7 weeks
Individual appetite sensation items (VAS for satiety, hunger, fullness, prospective consumption, desire to eat), in comparison between each verum group vs no treatment group - VAS values at all time points 0, 15, 30, 45, 60, 90, 120, 180, 210, 240 min
Visual analogue scales (VAS) for satiety, hunger, fullness, prospective consumption, desire to eat will be reported as follows:
Subjects had to record their appetite sensation before and after consumption of the standardised breakfast provided on site. VAS, 100-mm in length, were used to assess the following items:
- Hunger: How hungry are you? (Not at all <-> Extremely / As hungry as I have ever felt)
- Fullness: How full are you? (Not at all <-> Extremely / As full as I have ever felt)
- Satiety: How satiated are you? (Not at all <-> Extremely)
- Desire to eat (appetite): How strong is your desire to eat? (Very weak / Extremely low <-> Very strong / Extremely high)
- Prospective consumption (Quantity): How much do you think you could (or would want to) eat right now? (Nothing at all <-> A very large amount)
Measured: 2 -7 weeks
Individual appetite sensation items (VAS for satiety, hunger, fullness, prospective consumption, desire to eat), in comparison between each verum group vs no treatment group - maximal/minimal VAS values
Visual analogue scales (VAS) for satiety, hunger, fullness, prospective consumption, desire to eat will be reported as follows:
Subjects had to record their appetite sensation before and after consumption of the standardised breakfast provided on site. VAS, 100-mm in length, were used to assess the following items:
- Hunger: How hungry are you? (Not at all <-> Extremely / As hungry as I have ever felt)
- Fullness: How full are you? (Not at all <-> Extremely / As full as I have ever felt)
- Satiety: How satiated are you? (Not at all <-> Extremely)
- Desire to eat (appetite): How strong is your desire to eat? (Very weak / Extremely low <-> Very strong / Extremely high)
- Prospective consumption (Quantity): How much do you think you could (or would want to) eat right now? (Nothing at all <-> A very large amount)
Measured: 2 -7 weeks
Individual appetite sensation items (VAS for satiety, hunger, fullness, prospective consumption, desire to eat), in comparison between each verum group vs no treatment group - total AUC 0-15, 0-30, 0-45, 0-60, 0-90, 0-120, 0-180, 0-210, 0-240 min
Visual analogue scales (VAS) for satiety, hunger, fullness, prospective consumption, desire to eat will be reported as follows:
Subjects had to record their appetite sensation before and after consumption of the standardised breakfast provided on site. VAS, 100-mm in length, were used to assess the following items:
- Hunger: How hungry are you? (Not at all <-> Extremely / As hungry as I have ever felt)
- Fullness: How full are you? (Not at all <-> Extremely / As full as I have ever felt)
- Satiety: How satiated are you? (Not at all <-> Extremely)
- Desire to eat (appetite): How strong is your desire to eat? (Very weak / Extremely low <-> Very strong / Extremely high)
- Prospective consumption (Quantity): How much do you think you could (or would want to) eat right now? (Nothing at all <-> A very large amount)
Measured: 2 -7 weeks
Individual appetite sensation items (VAS for satiety, hunger, fullness, prospective consumption, desire to eat), in comparison between each verum group vs no treatment group - incremental AUC 0-15, 0-30, 0-45, 0-60, 0-90, 0-120, 0-180, 0-210, 0-240 min
Visual analogue scales (VAS) for satiety, hunger, fullness, prospective consumption, desire to eat will be reported as follows:
Subjects had to record their appetite sensation before and after consumption of the standardised breakfast provided on site. VAS, 100-mm in length, were used to assess the following items:
- Hunger: How hungry are you? (Not at all <-> Extremely / As hungry as I have ever felt)
- Fullness: How full are you? (Not at all <-> Extremely / As full as I have ever felt)
- Satiety: How satiated are you? (Not at all <-> Extremely)
- Desire to eat (appetite): How strong is your desire to eat? (Very weak / Extremely low <-> Very strong / Extremely high)
- Prospective consumption (Quantity): How much do you think you could (or would want to) eat right now? (Nothing at all <-> A very large amount)
Measured: 2 -7 weeks
Composite score ([desire to eat + hunger + (100-fullness) + prospective consumption]/4), in comparison between each verum group vs no treatment group - VAS values at all time points 0, 15, 30, 45, 60, 90, 120, 180, 210, 240 min
Composite score is calculated as follows:([desire to eat + hunger + (100 - satiety) + estimated consumption]/4).
Subjects had to record their appetite sensation before and after consumption of the standardised breakfast provided on site. Visual analogue scales (VAS), 100-mm in length, were used to assess the following items:
- Hunger: How hungry are you? (Not at all <-> Extremely / As hungry as I have ever felt)
- Satiety: How satiated are you? (Not at all <-> Extremely)
- Desire to eat (appetite): How strong is your desire to eat? (Very weak / Extremely low <-> Very strong / Extremely high)
- Prospective consumption (Quantity): How much do you think you could (or would want to) eat right now? (Nothing at all <-> A very large amount)
Measured: 2 -7 weeks
Composite score ([desire to eat + hunger + (100-fullness) + prospective consumption]/4), in comparison between each verum group vs no treatment group - maximal/minimal VAS values
Composite score is calculated as follows:([desire to eat + hunger + (100 - satiety) + estimated consumption]/4).
Subjects had to record their appetite sensation before and after consumption of the standardised breakfast provided on site. Visual analogue scales (VAS), 100-mm in length, were used to assess the following items:
- Hunger: How hungry are you? (Not at all <-> Extremely / As hungry as I have ever felt)
- Satiety: How satiated are you? (Not at all <-> Extremely)
- Desire to eat (appetite): How strong is your desire to eat? (Very weak / Extremely low <-> Very strong / Extremely high)
- Prospective consumption (Quantity): How much do you think you could (or would want to) eat right now? (Nothing at all <-> A very large amount)
Measured: 2 -7 weeks
Composite score ([desire to eat + hunger + (100-fullness) + prospective consumption]/4), in comparison between each verum group vs no treatment group - total AUC 0-15, 0-30, 0-45, 0-60, 0-90, 0-120, 0-180, 0-210, 0-240 min
Composite score is calculated as follows:([desire to eat + hunger + (100 - satiety) + estimated consumption]/4).
Subjects had to record their appetite sensation before and after consumption of the standardised breakfast provided on site. Visual analogue scales (VAS), 100-mm in length, were used to assess the following items:
- Hunger: How hungry are you? (Not at all <-> Extremely / As hungry as I have ever felt)
- Satiety: How satiated are you? (Not at all <-> Extremely)
- Desire to eat (appetite): How strong is your desire to eat? (Very weak / Extremely low <-> Very strong / Extremely high)
- Prospective consumption (Quantity): How much do you think you could (or would want to) eat right now? (Nothing at all <-> A very large amount)
Measured: 2 -7 weeks
Composite score ([desire to eat + hunger + (100-fullness) + prospective consumption]/4), in comparison between each verum group vs no treatment group - incremental AUC 0-15, 0-30, 0-45, 0-60, 0-90, 0-120, 0-180, 0-210, 0-240 min
Composite score is calculated as follows:([desire to eat + hunger + (100 - satiety) + estimated consumption]/4).
Subjects had to record their appetite sensation before and after consumption of the standardised breakfast provided on site. Visual analogue scales (VAS), 100-mm in length, were used to assess the following items:
- Hunger: How hungry are you? (Not at all <-> Extremely / As hungry as I have ever felt)
- Satiety: How satiated are you? (Not at all <-> Extremely)
- Desire to eat (appetite): How strong is your desire to eat? (Very weak / Extremely low <-> Very strong / Extremely high)
- Prospective consumption (Quantity): How much do you think you could (or would want to) eat right now? (Nothing at all <-> A very large amount)
Measured: 2 -7 weeks
24 hour energy intake on test days: breakfast+ad libitum lunch+diary records, in comparison between each verum group vs no treatment group
After each of the site visits on test days, food and beverage intake during the time period until 24 hours after start of site visit had to be documented by the subjects in the study diary and the energy.
Measured: 2 -7 weeks
PPG, in comparison between each verum group vs no treatment group - concentration at all time points 0, 15, 30, 45, 60, 90, 120, 180 min
Venous blood samples were drawn for the determination of glucose values
Measured: 2 -7 weeks
PPG, in comparison between each verum group vs no treatment group - maximal concentration
Venous blood samples were drawn for the determination of glucose values
Measured: 2 -7 weeks
PPG, in comparison between each verum group vs no treatment group - total AUC 0-15, 0-30, 0-45, 0-60, 0-90, 0-120, 0-180 min
Venous blood samples were drawn for the determination of glucose values
Measured: 2 -7 weeks
PPG, in comparison between each verum group vs no treatment group - incremental AUC 0-15, 0-30, 0-45, 0-60, 0-90, 0-180 min
Venous blood samples were drawn for the determination of glucose values
Measured: 2 -7 weeks
PPI, in comparison between each verum group vs no treatment group - concentration at all time points 0, 15, 30, 45, 60, 90, 120, 180 min
Venous blood samples were drawn for the determination of insulin values
Measured: 2 -7 weeks
PPI, in comparison between each verum group vs no treatment group - maximal concentration
Venous blood samples were drawn for the determination of insulin values
Measured: 2 -7 weeks
PPI, in comparison between each verum group vs no treatment group - total AUC 0-15, 0-30, 0-45, 0-60, 0-90, 0-120, 0-180 min
Venous blood samples were drawn for the determination of insulin values
Measured: 2 -7 weeks
PPI, in comparison between each verum group vs no treatment group - incremental AUC 0-15, 0-30, 0-45, 0-60, 0-90, 0-120, 0-180 min
Venous blood samples were drawn for the determination of insulin values
Measured: 2 -7 weeks
Global evaluation (by 4-point scale) of benefit by subject and the investigator, in comparison between each verum group vs no treatment group
The investigators had to evaluate the benefit of the treatment type (global scaled evaluation with "very good", "good", "moderate" and "poor").
Measured: 2 -7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2020
- Study start28 Jun 2019
- Primary completion27 Sep 2019
- Study completion27 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Double-blind, randomized, controlled, three-way cross-over design, monocentric nutritional study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nexira
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Analyze & Realize
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04515277
- Sponsor's protocol ID
- NEX/005519
- Status last verified
- Aug 2020
- First submitted
- 7 Aug 2020
- Last updated
- 19 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-blind, Randomized, Controlled, Three-way Cross-over Study to Evaluate the Effect of Gum Acacia (FibregumTM) on Post-prandial Glucose and Insulin Levels and Food Intake
- ClinicalTrials.gov ID
- NCT04515277
- Acronym / sponsor ID
- NEX/005519
- Conditions
- Healthy, Overweight
- Keywords
- gum acacia, post-prandial glucose (PPG), post-prandial insulin (PPI), blood glucose incremental, appetite sensation, E 414, food additive, FibregumTM
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- NexiraIndustry (pharma, biotech, devices)
- Collaborators
- Analyze & Realize
- Study start
- 28 Jun 2019 (actual)
- Primary completion
- 27 Sep 2019 (actual)
- Study completion
- 27 Sep 2019 (actual)
- First posted
- 17 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study to evaluate the effect of gum acacia (FibregumTM) on post-prandial glucose and insulin levels and food intake in normal-weight and overweight subjects during a 2-7 weeks intervention period. In addition, tolerability and safety of gum acacia (FibregumTM) will be assessed.
Detailed description
Gum arabic is a heteropolysaccharide (molecular weight 350-850 kDa) harvested from Acacia seyal or Acacia senegal. It is highly soluble and broadly used in numerous solid and liquid food matrices.
For the assessment of non-digestible carbohydrates as dietary fiber, it is eminent to demonstrate that its consumption is related to a specific beneficial physiological effect shown in an appropriate clinical study. The aim of the present trial was to expand the clinical evidence with respect to beneficial effects of gum acacia on post-prandial blood glucose levels, post-prandial insulin levels and prospective ad libitum food intake, in normal-weight and overweight subjects.
The present double-blind, randomized, controlled, three-way cross-over study was to evaluate the effect of gum acacia versus no treatment on post-prandial glucose (PPG) levels in normal-weight and overweight subjects during a 2-7 weeks intervention period.
Additionally, post-prandial insulin (PPI) levels, prospective ad libitum food intake, as well as the safety and tolerability of gum acacia were assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Double-blind, randomized, controlled, three-way cross-over design, monocentric nutritional study
| Arm | Type | Receives |
|---|---|---|
| 40 g (D1) | Active comparator | Dietary Supplement: 40 g Gum acacia (FibregumTM)40 g gum acacia powder (D1). Treatment type is applied with the standardized breakfast (in 300 mL orange juice) on the test days (V2, V3 or V4). |
| 20 g (D2) | Active comparator | Dietary Supplement: 20 g Gum acacia (FibregumTM)20 g gum acacia powder (D2). Treatment type is applied with the standardized breakfast (in 300 mL orange juice) on the test days (V2, V3 or V4). |
| No treatment (NT) | Other | Dietary Supplement: 0 g Gum acacia (FibregumTM)0 g gum acacia powder. Standardized breakfast (in 300 mL orange juice) on the test days (V2, V3 or V4). |
Who may qualify
- Ages
- 25 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (16 listed)
- Men and women from 25 to 60 years old
- Body mass index (BMI) 18.5 kg/m2 - 29.9 kg/m2
- Generally in good health
- Normal fasting blood glucose (FBG) 3.9 to <5.6 mmol/L (70 to <100 mg/dL) and HbA1c of 4 to <5.7 %
- Regularly consuming 3 main meals/day, with breakfast and lunch as dominant meals
Key exclusion criteria (27 listed)
- Known allergy or hypersensitivity to the components of the investigational product / study meals
- History and/or presence of clinically significant self-reported disorder as per investigator's judgement:
- Subjects with difficult vein access or sensitive to blood draws
- Nighttime eating/snacking (after 10 pm)
- Excessive consumption of artificial sweeteners (e.g. in beverages)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 40 g Gum acacia (FibregumTM)Also: D1Applied in 300 mL of orange juice with breakfast (single use at visit) | Dietary supplement | 40 g (D1) |
| 20 g Gum acacia (FibregumTM)Also: D2Applied in 300 mL of orange juice with breakfast (single use at visit) | Dietary supplement | 20 g (D2) |
| 0 g Gum acacia (FibregumTM)Also: no treatment300 mL of orange juice with breakfast (single use at visit) | Dietary supplement | No treatment (NT) |
Primary outcome
Difference in blood glucose incremental AUC 0-120 min between D1 verum group and no treatment group
Time frame: 2 -7 weeks
Venous blood samples were drawn for the determination of glucose values, with sampling times at -15 min and immediately prior to the intake of the standardized breakfast (time "0") as well as 15, 30, 45, 60, 90 and 120 min after the "0 min" blood draw.
20 secondary outcomes
Difference in blood glucose incremental AUC 0-120 min between D2 verum group and no treatment group
Time frame: 2 -7 weeks
Food (energy) intake at ad libitum lunch, in comparison between each verum group vs no treatment group
Time frame: 2 -7 weeks
Individual appetite sensation items (VAS for satiety, hunger, fullness, prospective consumption, desire to eat), in comparison between each verum group vs no treatment group - VAS values at all time points 0, 15, 30, 45, 60, 90, 120, 180, 210, 240 min
Time frame: 2 -7 weeks
Individual appetite sensation items (VAS for satiety, hunger, fullness, prospective consumption, desire to eat), in comparison between each verum group vs no treatment group - maximal/minimal VAS values
Time frame: 2 -7 weeks
Individual appetite sensation items (VAS for satiety, hunger, fullness, prospective consumption, desire to eat), in comparison between each verum group vs no treatment group - total AUC 0-15, 0-30, 0-45, 0-60, 0-90, 0-120, 0-180, 0-210, 0-240 min
Time frame: 2 -7 weeks
Individual appetite sensation items (VAS for satiety, hunger, fullness, prospective consumption, desire to eat), in comparison between each verum group vs no treatment group - incremental AUC 0-15, 0-30, 0-45, 0-60, 0-90, 0-120, 0-180, 0-210, 0-240 min
Time frame: 2 -7 weeks
Composite score ([desire to eat + hunger + (100-fullness) + prospective consumption]/4), in comparison between each verum group vs no treatment group - VAS values at all time points 0, 15, 30, 45, 60, 90, 120, 180, 210, 240 min
Time frame: 2 -7 weeks
Composite score ([desire to eat + hunger + (100-fullness) + prospective consumption]/4), in comparison between each verum group vs no treatment group - maximal/minimal VAS values
Time frame: 2 -7 weeks
Composite score ([desire to eat + hunger + (100-fullness) + prospective consumption]/4), in comparison between each verum group vs no treatment group - total AUC 0-15, 0-30, 0-45, 0-60, 0-90, 0-120, 0-180, 0-210, 0-240 min
Time frame: 2 -7 weeks
Composite score ([desire to eat + hunger + (100-fullness) + prospective consumption]/4), in comparison between each verum group vs no treatment group - incremental AUC 0-15, 0-30, 0-45, 0-60, 0-90, 0-120, 0-180, 0-210, 0-240 min
Time frame: 2 -7 weeks
24 hour energy intake on test days: breakfast+ad libitum lunch+diary records, in comparison between each verum group vs no treatment group
Time frame: 2 -7 weeks
PPG, in comparison between each verum group vs no treatment group - concentration at all time points 0, 15, 30, 45, 60, 90, 120, 180 min
Time frame: 2 -7 weeks
PPG, in comparison between each verum group vs no treatment group - maximal concentration
Time frame: 2 -7 weeks
PPG, in comparison between each verum group vs no treatment group - total AUC 0-15, 0-30, 0-45, 0-60, 0-90, 0-120, 0-180 min
Time frame: 2 -7 weeks
PPG, in comparison between each verum group vs no treatment group - incremental AUC 0-15, 0-30, 0-45, 0-60, 0-90, 0-180 min
Time frame: 2 -7 weeks
PPI, in comparison between each verum group vs no treatment group - concentration at all time points 0, 15, 30, 45, 60, 90, 120, 180 min
Time frame: 2 -7 weeks
PPI, in comparison between each verum group vs no treatment group - maximal concentration
Time frame: 2 -7 weeks
PPI, in comparison between each verum group vs no treatment group - total AUC 0-15, 0-30, 0-45, 0-60, 0-90, 0-120, 0-180 min
Time frame: 2 -7 weeks
PPI, in comparison between each verum group vs no treatment group - incremental AUC 0-15, 0-30, 0-45, 0-60, 0-90, 0-120, 0-180 min
Time frame: 2 -7 weeks
Global evaluation (by 4-point scale) of benefit by subject and the investigator, in comparison between each verum group vs no treatment group
Time frame: 2 -7 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 40 g Gum acacia (FibregumTM), 20 g Gum acacia (FibregumTM) and 0 g Gum acacia (FibregumTM) in people with Healthy and Overweight, run by Nexira at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in blood glucose incremental AUC 0-120 min between D1 verum group and no treatment group (time frame: 2 -7 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2020.