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

NCT ID: NCT04515277

Last Updated: 2020-08-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-28
• Study Completion Date: 2019-09-27

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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).

Group Type: ACTIVE_COMPARATOR

40 g Gum acacia (FibregumTM)

Intervention Type: DIETARY_SUPPLEMENT

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

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).

Group Type: ACTIVE_COMPARATOR

20 g Gum acacia (FibregumTM)

Intervention Type: DIETARY_SUPPLEMENT

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

No treatment (NT)

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

Group Type: OTHER

0 g Gum acacia (FibregumTM)

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

40 g Gum acacia (FibregumTM)

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

Intervention Type: DIETARY_SUPPLEMENT

20 g Gum acacia (FibregumTM)

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

Intervention Type: DIETARY_SUPPLEMENT

0 g Gum acacia (FibregumTM)

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

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

D1; D2; no treatment

Eligibility Criteria

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

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

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Analyze & Realize

NETWORK

Sponsor Role: collaborator

Nexira

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Analyze & Realize

Berlin, , Germany

Countries

Germany

Other Identifiers

NEX/005519

Identifier Type: -

Identifier Source: org_study_id