Commercial Prebiotic Supplement Study

NCT03141710 | Completed

• 1 other identifier: Study 805
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

Previous work in 2015/16 has identified changes in the gut microbiota with prebiotic (Molkosan®) supplement. It report significant changes in metabolic health bio-markers and faecal SCFA profile in 18 health adult subjects consuming 20 ml of product twice a day. Improvement in fasting metabolic parameters was observed flowing the intervention period. A reduction on Total Cholesterol, Glucose, Triglycerides and Insulin was observed. In this study, a lower dose (20ml/d) in subjects with type 2 diabetes will be examed, over an extended period of time (12 week period) to match the profile of the intended consumer and provide preliminary data to support a larger multi-centre trial.

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• Change of oral glucose tolerance test (OGTT)

  Six blood samples will be collected during the course of 3 hours (0, 30, 60, 90,120 and 180 min) using a cannulation after consuming 75 g of Polycal liquid (glucose load). Plasma glucose level will be measured by KONI analysis and

  At baseline and 12 weeks prebiotic consumption

Secondary Outcomes (10)

• Change of insulin levels

  At baseline, 6 weeks and 12 weeks prebiotic consumption

• HbA1c measured by Alere Afinion™ AS100 Analyzer

  At baseline and 12 weeks prebiotic consumption

• Change of BMI (kg/m^2) measurement

  At baseline and 12 weeks prebiotic consumption

• Change of Total Cholesterol levels

  At baseline, 6 weeks and 12 weeks prebiotic consumption

• Change of GLP-1 levels

  At baseline, 6 weeks and 12 weeks prebiotic consumption

Study Arms (1)

12 type 2 diabetes patients

EXPERIMENTAL

Long-term dietary (12 weeks) intervention of 20ml of prebiotic per day

Dietary Supplement: 20 ml of prebiotic per day

Interventions

20 ml of prebiotic per day DIETARY_SUPPLEMENT

12 volunteers will take 20ml of prebiotic per day for 12 weeks

12 type 2 diabetes patients

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Impaired glucose tolerance (IGT, identified by HbA1c) or type 2 diabetes (lifestyle management; identified by HbA1c) age 18-65, with BMI 18-40 kg m-2, measured at screening visit.

You may not qualify if:

• Type 1 Diabetes, Severe gastrointestinal disorders (IBD), Kidney disease, Thromboembolic or coagulation disease, Hepatic disease, Alcohol or any other substance abuse, Eating disorders, Unregulated thyroid disease, Antibiotic use within the last 3 months, including proscribed and prescribed use. Current probiotic use or prebiotic use. Medication for glucose regulation. Female with breast feeding.

Sponsors & Collaborators

• University of Aberdeen: lead

Study Sites (1)

The Rowett Institute, Human Nutrition Unit

Aberdeen, AB25 2ZD, United Kingdom

Location

Related Publications (6)

• Gibson GR, Roberfroid MB. Dietary modulation of the human colonic microbiota: introducing the concept of prebiotics. J Nutr. 1995 Jun;125(6):1401-12. doi: 10.1093/jn/125.6.1401.

  PMID: 7782892 BACKGROUND

• Kenteu B, Noubiap JJ, Etoa MC, Azabji-Kenfack M, Dehayem M, Sobngwi E. Acute glycaemic effects of co-trimoxazole at prophylactic dose in healthy adults. BMC Endocr Disord. 2016 Nov 15;16(1):62. doi: 10.1186/s12902-016-0142-6.

  PMID: 27927207 BACKGROUND

• Marathe CS, Rayner CK, Lange K, Bound M, Wishart J, Jones KL, Kahn SE, Horowitz M. Relationships of the early insulin secretory response and oral disposition index with gastric emptying in subjects with normal glucose tolerance. Physiol Rep. 2017 Feb;5(4):e13122. doi: 10.14814/phy2.13122. Epub 2017 Feb 27.

  PMID: 28242817 BACKGROUND

• Salonen A, Lahti L, Salojarvi J, Holtrop G, Korpela K, Duncan SH, Date P, Farquharson F, Johnstone AM, Lobley GE, Louis P, Flint HJ, de Vos WM. Impact of diet and individual variation on intestinal microbiota composition and fermentation products in obese men. ISME J. 2014 Nov;8(11):2218-30. doi: 10.1038/ismej.2014.63. Epub 2014 Apr 24.

  PMID: 24763370 BACKGROUND

• Walker AW, Ince J, Duncan SH, Webster LM, Holtrop G, Ze X, Brown D, Stares MD, Scott P, Bergerat A, Louis P, McIntosh F, Johnstone AM, Lobley GE, Parkhill J, Flint HJ. Dominant and diet-responsive groups of bacteria within the human colonic microbiota. ISME J. 2011 Feb;5(2):220-30. doi: 10.1038/ismej.2010.118. Epub 2010 Aug 5.

  PMID: 20686513 BACKGROUND

• Yanagimachi T, Fujita Y, Takeda Y, Honjo J, Sakagami H, Kitsunai H, Takiyama Y, Abiko A, Makino Y, Kieffer TJ, Haneda M. Dipeptidyl peptidase-4 inhibitor treatment induces a greater increase in plasma levels of bioactive GIP than GLP-1 in non-diabetic subjects. Mol Metab. 2016 Dec 31;6(2):226-231. doi: 10.1016/j.molmet.2016.12.009. eCollection 2017 Feb.

  PMID: 28180064 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Alexandra M Johnstone, PhD

  University of Aberdeen, The Rowett Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 20ml of prebiotic per day for 12 weeks

Study Record Dates

• First Submitted: February 8, 2017
• First Posted: May 5, 2017
• Study Start: May 10, 2017
• Primary Completion: July 18, 2017
• Study Completion: July 18, 2017
• Last Updated: May 14, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)