Effect of Fermentable Carbohydrate on Glucose Homeostasis (FermCarb)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by Imperial College London
Sponsor:
Information provided by (Responsible Party):
Imperial College London
ClinicalTrials.gov Identifier:
NCT01841073
First received: April 5, 2013
Last updated: April 25, 2013
Last verified: April 2013
  Purpose

The rise in the prevalence of type 2 diabetes is related to recent lifestyle changes leading to a rise in obesity. Obesity is a risk factor for Impaired Glucose Tolerance (IGT) and diabetes. A type of fibre - fermentable carbohydrate - may help prevent diabetes in individuals with IGT by reducing appetite and food intake, and improving insulin sensitivity. Although fermentable carbohydrate is not absorbed in the small intestine it is full fermented by the colonic bacteria. The fermentation of this carbohydrate produces short chain fatty acids which act on specific G protein coupled receptors (GPR41/43) in the intestine to release GLP-1 and PYY. GLP-1 and PYY are hormones which act on appetite centres in the brain to decrease appetite. GLP-1 incretin effects and possible effect of the beta cell will increase insulin sensitivity. Short chain fatty acids also suppress the release of free fatty acids from adipocytes. Lower levels of free fatty acids in insulin resistant subject's leads to improved insulin sensitivity. This body of work will examine the effect of fermentable carbohydrate on appetite, weight loss, blood glucose control which will give an indication of the possibility of fermentable carbohydrate to prevent type 2 diabetes in this at-risk group.


Condition Intervention
Prediabetes
Dietary Supplement: Inulin
Dietary Supplement: Cellulose

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effect of Fermentable Carbohydrate on Glucose Homeostasis and Weight Management in Subjects With Prediabetes

Resource links provided by NLM:


Further study details as provided by Imperial College London:

Primary Outcome Measures:
  • Glycaemic control [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]

    Change in glycaemic control over 18 weeks both fasting and post-prandial. Measures of glycaemic control (glucose, insulin and the calculated values: HOMA-IR, Matsuda and Insulinogenic Index) will be measured at baseline, 9 and 18 weeks.

    The delta change at baseline and 9 weeks, baseline and 18 weeks and 9 and 18 weeks will be compared between intervention groups.

    The delta change between baseline and 18 weeks will be calculated.



Secondary Outcome Measures:
  • Food intake [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]
    Change in food intake following intervention over 18 weeks


Other Outcome Measures:
  • Change in body weight [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]
    Change in body weight over 18 week intervention


Estimated Enrollment: 93
Study Start Date: March 2011
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Inulin
Subject will take 10g inulin for 2 weeks, 20g of inulin for the next 2 weeks and then 30g for the remainder of the investigations.
Dietary Supplement: Inulin
Subjects will have 4 dietary counselling sessions in the first 9 weeks of the study with a goal to lose 5% of their body weight by week 9. They will be asked to maintain their weight loss until week 18.
Other Name: Synergy1
Dietary Supplement: Inulin
Subject will take inulin for 6 weeks in total with no other change to their diet or lifestyle.
Other Name: Synergy1
Dietary Supplement: Inulin

Subject will take inulin for 6 weeks in total with no other change to their diet or lifestyle.

Subject will wear a Continuous Glucose Monitor for 4 x 5 days during the study.

Other Name: Synergy1
Placebo Comparator: Cellulose
Subjects will take 10g cellulose a day for 2 weeks, followed by 20g a day for 2 weeks, then 30g a day for the rest of the study.
Dietary Supplement: Cellulose
Subjects will have 4 dietary counselling sessions in the first 9 weeks of the study with a goal to lose 5% of their body weight by week 9. They will be asked to maintain their weight loss until week 18.
Dietary Supplement: Cellulose
Subject will take cellulose for 6 weeks in total with no other change to their diet or lifestyle.
Dietary Supplement: Cellulose

Subject will take cellulose for 6 weeks in total with no other change to their diet or lifestyle.

Subject will wear a Continuous Glucose Monitor for 4 x 5 days during the study.


  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Investigation 1 and 3: An oral glucose tolerance test diagnostic of impaired glucose tolerance as defined by the WHO as a fasting plasma glucose<7.0mmol/l and a 2-h plasma glucose ≥7.8 and <11.1mmol/l and/or impaired fasting glucose, defined by the American Diabetes Association as a fasting plasma glucose of >5.6 and <6.9mmol/L.
  • Investigation 2: An oral glucose tolerance test diagnostic of impaired glucose tolerance as defined by the WHO as a fasting plasma glucose<7.0mmol/l and a 2-h plasma glucose ≥7.8 and <11.1mmol/l. For investigation 2, people with only IFG will be excluded.
  • All investigations:
  • Adults over 18 years of age
  • Males and Females with a BMI between 25-35 kg/m2. The BMI range of between 25-35Kg/m2 has been chosen as this is the range that the majority of overweight people fall into (1). At this level of overweight and obesity there is an increase in the risk of type 2 diabetes. Above 40 kg/m2 there appears to be decreased success with lifestyle advice.
  • The volunteers should have given full written consent.
  • Have had a stable body weight for the last 6 months with no more than a 5% change in body weight over 6 months.

Exclusion Criteria:

  • Adults less than 18 years of age.
  • Volunteers with a major metabolic disease - including diabetes.
  • A normal oral glucose tolerance test or that diagnostic of diabetes by the WHO criteria.
  • Pregnant and lactating women.
  • Males and Females with a BMI less than 25kg/m2 or greater than 35kg/m2
  • Volunteers unable to give informed consent for themselves.
  • Has lost or gained 5% of their normal body weight in the last 6 months.
  • Has a known/diagnosed gastrointestinal problem such as inflammatory bowel disease, irritable bowel syndrome etc
  • Failure of the medical examination for inclusion into the study
  • Those with anaemia (Hb <10g/l)
  • Drug or alcohol abuse in the last 2 years.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01841073

Contacts
Contact: Gary Frost, PhD 020 8383 8037 g.frost@imperial.ac.uk
Contact: Nicola D Guess, MPH 07951 252395 n.guess10@imperial.ac.uk

Locations
United Kingdom
Imperial College London Recruiting
London, United Kingdom, W11 0NN
Contact: Nicola Guess, MPH    07951 252395    n.guess10@imperial.ac.uk   
Sub-Investigator: Nicola D Guess, RD MPH         
Principal Investigator: Gary S Frost, PhD         
Sponsors and Collaborators
Imperial College London
  More Information

No publications provided

Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT01841073     History of Changes
Other Study ID Numbers: FermCarb
Study First Received: April 5, 2013
Last Updated: April 25, 2013
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Imperial College London:
Prediabetes
Fermentable carbohydrate
Appetite
Glucose homeostasis
Weight management

Additional relevant MeSH terms:
Glucose Intolerance
Prediabetic State
Hyperglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Diabetes Mellitus
Endocrine System Diseases

ClinicalTrials.gov processed this record on August 21, 2014