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Role of Colonic Short Chain Fatty Acids in Obesity

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ClinicalTrials.gov Identifier: NCT02562014
Recruitment Status : Completed
First Posted : September 29, 2015
Last Update Posted : September 29, 2015
Sponsor:
Information provided by (Responsible Party):
Thomas Wolever, University of Toronto

Brief Summary:
The excess production of colonic short-chain-fatty-acids (SCFA) has been implicated in the promotion of obesity, but colonic fermentation of dietary-fiber to SCFA may also play a role in preventing diabetes. The investigators aimed to compare the effects of two fermentable fibers (inulin and resistant-starch) on postprandial SCFA, glucose, insulin, free-fatty acids (FFA) and gut hormone responses and to compare the responses in healthy overweight and obese (OWO) vs lean (LN) participants. Methods: Using a randomized, single blind, crossover design, 13 OWO and 12 LN overnight fasted participants were studied on 3 separate occasions. On each day they consumed a 300 mL drink containing 75g glucose (Control) or 75g glucose plus 24g inulin (IN), or 28.2g resistant-starch (RS). A standard lunch was served 4 h after the test drink.

Condition or disease Intervention/treatment Phase
Obesity Other: Glucose Other: Inulin Other: Resistant Starch Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Effect of Inulin and Resistant Starch on Postprandial Short Chain Fatty Acid, Glucose, Insulin and Gut Hormone Responses in Lean and Overweight Subjects.
Study Start Date : February 2012
Actual Primary Completion Date : July 2012
Actual Study Completion Date : January 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Starch Inulin

Arm Intervention/treatment
Lean
Participants with body mass index <=25
Other: Glucose
75g glucose

Other: Inulin
75g glucose plus 24g inulin

Other: Resistant Starch
75g glucose plus 28.2g resistant starch

Overweight
Participants with body mass index >25
Other: Glucose
75g glucose

Other: Inulin
75g glucose plus 24g inulin

Other: Resistant Starch
75g glucose plus 28.2g resistant starch




Primary Outcome Measures :
  1. Incremental area under the serum acetate response curve [ Time Frame: For 6 hours after consuming the test meal ]

Secondary Outcome Measures :
  1. Incremental area under the serum propionate response curve [ Time Frame: For 6 hours after consuming the test meal ]
  2. Incremental area under the serum butyrate response curve [ Time Frame: For 6 hours after consuming the test meal ]
  3. Incremental area under the breath hydrogen response curve [ Time Frame: For 6 hours after consuming the test meal ]
  4. Incremental area under the breath methane response curve [ Time Frame: For 6 hours after consuming the test meal ]
  5. Incremental area under the serum glucose response curve [ Time Frame: For 4 hours after consuming the test meal ]
  6. Incremental area under the serum glucose response curve [ Time Frame: For 2 hours after consuming the standard lunch ]
  7. Incremental area under the serum insulin response curve [ Time Frame: For 4 hours after consuming the test meal ]
  8. Incremental area under the serum insulin response curve [ Time Frame: For 2 hours after consuming the standard lunch ]
  9. Incremental area under the serum c-peptide response curve [ Time Frame: For 4 hours after consuming the test meal ]
  10. Incremental area under the serum c-peptide response curve [ Time Frame: For 2 hours after consuming the standard lunch ]
  11. Total area under the serum free-fatty acid response curve [ Time Frame: For 4 hours after consuming the test meal ]
  12. Total area under the serum free-fatty acid response curve [ Time Frame: For 2 hours after consuming the standard lunch ]

Other Outcome Measures:
  1. Incremental area under the serum glucagon-like peptide-1 response curve [ Time Frame: For 4 hours after consuming the test meal ]
  2. Incremental area under the serum glucagon-like peptide-1 response curve [ Time Frame: For 2 hours after consuming the standard lunch ]
  3. Incremental area under the serum peptide-YY response curve [ Time Frame: For 4 hours after consuming the test meal ]
  4. Incremental area under the serum peptide-YY response curve [ Time Frame: For 2 hours after consuming the standard lunch ]
  5. Incremental area under the serum ghrelin response curve [ Time Frame: For 4 hours after consuming the test meal ]
  6. Incremental area under the serum ghrelin response curve [ Time Frame: For 2 hours after consuming the standard lunch ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • non-pregnant
  • body mass index >=20 and <=35

Exclusion Criteria:

  • history of diabetes mellitus
  • history of cardiovascular disease
  • history of bowel disease
  • history of kidney disease
  • history of liver disease
  • use of antibiotics within 3 months of enrolment
  • unusual dietary habits
  • fasting glucose >6.9mmol/L
  • hematocrit below normal range for age and sex

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02562014


Sponsors and Collaborators
University of Toronto
Investigators
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Principal Investigator: Thomas MS Wolever, MD, PhD University of Toronto
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Thomas Wolever, Professor, University of Toronto
ClinicalTrials.gov Identifier: NCT02562014    
Other Study ID Numbers: Protocol #27112
First Posted: September 29, 2015    Key Record Dates
Last Update Posted: September 29, 2015
Last Verified: September 2015
Additional relevant MeSH terms:
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Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms