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

NCT04515277 | Completed

• 1 other identifier: NEX/005519
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy; Overweight

Keywords

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

Outcome Measures

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.

  2 -7 weeks

Secondary Outcomes (20)

• Difference in blood glucose incremental AUC 0-120 min between D2 verum group and no treatment group

  2 -7 weeks

• Food (energy) intake at ad libitum lunch, in comparison between each verum group vs no treatment group

  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

  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

  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

  2 -7 weeks

Other Outcomes (7)

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

  2 -7 weeks

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

  2 -7 weeks

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

  2 -7 weeks

Study Arms (3)

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).

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).

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).

Dietary Supplement: 0 g Gum acacia (FibregumTM)

Interventions

40 g Gum acacia (FibregumTM) DIETARY_SUPPLEMENT

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

Also known as: D1

40 g (D1)

20 g Gum acacia (FibregumTM) DIETARY_SUPPLEMENT

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

Also known as: D2

20 g (D2)

0 g Gum acacia (FibregumTM) DIETARY_SUPPLEMENT

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

Also known as: no treatment

No treatment (NT)

Eligibility Criteria

• Age: 25 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• 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:

Sponsors & Collaborators

• Nexira: lead
• Analyze & Realize: collaborator

Study Sites (1)

Analyze & Realize

Berlin, 10369, Germany

Location

MeSH Terms

Conditions

Overweight

Interventions

Gum Arabic

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Plant Gums; Biopolymers; Polymers; Macromolecular Substances; Polysaccharides; Carbohydrates; Plant Exudates; Biological Products; Complex Mixtures

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Double-blind, randomized, controlled, three-way cross-over design, monocentric nutritional study

Study Record Dates

• First Submitted: August 7, 2020
• First Posted: August 17, 2020
• Study Start: June 28, 2019
• Primary Completion: September 27, 2019
• Study Completion: September 27, 2019
• Last Updated: August 19, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)