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CompletedNCT04515277Updated Aug 19, 2020

Study to Evaluate the Effect of Gum Acacia (FibregumTM) on Post-prandial Glucose, Insulin Levels and Food Intake

An interventional study of 40 g Gum acacia (FibregumTM) and 20 g Gum acacia (FibregumTM) in Healthy and Overweight, sponsored by Nexira. Completed at 1 site in Germany. Open to participants aged 25 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-08-19.

Sponsored by Nexira · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 1 month after the study started (first participant enrolled Jun 2019, registered Aug 2020).
Phase
Not applicable
Study type
Interventional
Enrollment
36
Allocation
Randomized
Ages
25 Years to 60 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Healthy
  • Overweight

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Keywords

  • gum acacia
  • post-prandial glucose (PPG)
  • post-prandial insulin (PPI)
  • blood glucose incremental
  • appetite sensation
  • E 414
  • food additive
  • FibregumTM
  • appetite
  • dietary fibre
03

In context

Overweight

3,670 studies on the registry are indexed under Overweight; 849 are open to participants now.

This study's enrollment of 36 is below the median of 73 across 3,175 interventional studies indexed under Overweight.

Browse Overweight studies →

Lead sponsor

Nexira is the lead sponsor of 5 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
25 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Men and women from 25 to 60 years old
  2. Body mass index (BMI) 18.5 kg/m2 - 29.9 kg/m2
  3. Generally in good health
  4. Normal fasting blood glucose (FBG) 3.9 to \<5.6 mmol/L (70 to \<100 mg/dL) and HbA1c of 4 to \<5.7 %
  5. Regularly consuming 3 main meals/day, with breakfast and lunch as dominant meals
  6. Familiar with components of the study meals, no disliking and/or extreme preferences for any of the items

  7. 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
  8. Stable body weight in the last 3 months prior to V1 (≤3% self-reported change)
  9. Stable concomitant medications (if any) for at least last 3 months prior to V1

  10. Women of childbearing potential:

    • commitment to use contraception methods
    • negative pregnancy testing (beta human chorionic gonadotropin test in urine) at V1
  11. Readiness not to participate in another clinical study during this study

Exclusion criteria

Exclusion Criteria:

  1. Known allergy or hypersensitivity to the components of the investigational product / study meals

  2. 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
    • 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
  3. Subjects with difficult vein access or sensitive to blood draws
  4. Nighttime eating/snacking (after 10 pm)
  5. Excessive consumption of artificial sweeteners (e.g. in beverages)
  6. History and/or presence of eating disorders like bulimia, anorexia nervosa, binge-eating as per investigator's judgement
  7. 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

  8. 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)
  9. Diet/weight loss programs within the last 3 months prior to V1 and during the study
  10. Recent blood donation within the last 1 month prior to study
  11. Smoking within the last 6 months prior to V1 and during the study
  12. Vegetarian, vegan or other restrictive diet
  13. Night shift work
  14. History or current abuse of alcohol, drug and/or medication
  15. Women of child-bearing potential: pregnancy or nursing
  16. Inability to comply with study procedures
  17. Participation in another study during the last 30 days prior to V1
  18. Any other reason deemed suitable for exclusion, per investigator's judgment
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
36 participants (actual)

Study arms

  • Active comparator
    40 g (D1)

    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).

    Dietary Supplement: 40 g Gum acacia (FibregumTM)

  • Active comparator
    20 g (D2)

    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).

    Dietary Supplement: 20 g Gum acacia (FibregumTM)

  • Other
    No treatment (NT)

    0 g gum acacia powder. Standardized breakfast (in 300 mL orange juice) on the test days (V2, V3 or V4).

    Dietary Supplement: 0 g Gum acacia (FibregumTM)

Interventions

  • Dietary supplement40 g Gum acacia (FibregumTM)

    Applied in 300 mL of orange juice with breakfast (single use at visit)

    Also known as: D1

  • Dietary supplement20 g Gum acacia (FibregumTM)

    Applied in 300 mL of orange juice with breakfast (single use at visit)

    Also known as: D2

  • Dietary supplement0 g Gum acacia (FibregumTM)

    300 mL of orange juice with breakfast (single use at visit)

    Also known as: no treatment

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 2 -7 weeks

Secondary outcomes

  1. 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.

    Time frame: 2 -7 weeks

  2. 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.

    Time frame: 2 -7 weeks

  3. 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)

    Time frame: 2 -7 weeks

  4. 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)

    Time frame: 2 -7 weeks

  5. 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)

    Time frame: 2 -7 weeks

  6. 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)

    Time frame: 2 -7 weeks

  7. 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)

    Time frame: 2 -7 weeks

  8. 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)

    Time frame: 2 -7 weeks

  9. 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)

    Time frame: 2 -7 weeks

  10. 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)

    Time frame: 2 -7 weeks

  11. 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.

    Time frame: 2 -7 weeks

  12. 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

    Time frame: 2 -7 weeks

  13. PPG, in comparison between each verum group vs no treatment group - maximal concentration

    Venous blood samples were drawn for the determination of glucose values

    Time frame: 2 -7 weeks

  14. 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

    Time frame: 2 -7 weeks

  15. 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

    Time frame: 2 -7 weeks

  16. 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

    Time frame: 2 -7 weeks

  17. PPI, in comparison between each verum group vs no treatment group - maximal concentration

    Venous blood samples were drawn for the determination of insulin values

    Time frame: 2 -7 weeks

  18. 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

    Time frame: 2 -7 weeks

  19. 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

    Time frame: 2 -7 weeks

  20. 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").

    Time frame: 2 -7 weeks

Other outcomes

  1. Gastrointestinal tolerability evaluation (by 4-point scale), in comparison between each verum group and no treatment group

    Gastrointestinal tolerabilty was assessed by assessing the items burping, cramping, distension, flatulence, nausea, vomiting scored by means of a 4-point scale: 1=none, 2=mild, 3=moderate, 4=severe, on test days only, at 0 min (before the standardized breakfast) and at 1, 2, 3, 4, 6, 12 and 24 hours after intake of standardized breakfast in the subject diary

    Time frame: 2 -7 weeks

  2. Blood pressure (systolic and diastolic), in comparison between each verum group and no treatment group

    Sitting blood pressure (systolic and diastolic) was measured using standard procedures

    Time frame: 2 -7 weeks

  3. Pulse rate, in comparison between each verum group and no treatment group

    Sitting pulse rate was measured using standard procedures

    Time frame: 2 -7 weeks

  4. Global evaluation (by 4-point scale) of tolerability by subject and investigator at study end, in comparison between each verum group and no treatment group

    The investigators had to evaluate the tolerability of the treatment type (global scaled evaluation with "very good", "good", "moderate" and "poor").

    Time frame: 2 -7 weeks

  5. Assessment of adverse events throughout the study

    Any adverse event (AE) that occured during the course of the clinical study had to be recorded

    Time frame: 2 -7 weeks

  6. Body weight, in comparison between each verum group and no treatment group

    Body weight (kg) was measured in subjects in fasting condition wearing only underwear and barefoot, after emptying the bladder and bowels as needed, using standardized weighing scales (Tanita BC-420MA).

    Time frame: 2 -7 weeks

  7. Changes in dietary habits, physical activities and sleep habits by questioning, in comparison between each verum group and no treatment group

    The subjects were questioned with respect to any changes: * in their dietary habits (e.g lower/higher calorie intake) * in their sleep habits (e.g less/more sleep) * in their level of physical activity (e.g lower/higher activity level)

    Time frame: 2 -7 weeks

07

Study locations

1 site
  • Analyze & Realize
    Berlin, 10369, Germany
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 19, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04515277
Lead sponsor
Nexira
Collaborators
Analyze & Realize
Responsible party
Sponsor
First posted
Aug 17, 2020
Start date
Jun 28, 2019
Primary completion
Sep 27, 2019
Completion
Sep 27, 2019
Last update
Aug 19, 2020

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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