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Completed

NCT Number: NCT02562014

Role of Colonic Short Chain Fatty Acids in Obesity

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.

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Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Glucose

Other

75g glucose

Inulin

Other

75g glucose plus 24g inulin

Resistant starch

Other

75g glucose plus 28.2g resistant starch

Primary outcomes

  1. Incremental area under the serum acetate response curve

    Time frame: For 6 hours after consuming the test meal

Secondary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Toronto

Other

Registry information

Official study title

Effect of Inulin and Resistant Starch on Postprandial Short Chain Fatty Acid, Glucose, Insulin and Gut Hormone Responses in Lean and Overweight Subjects.

Important dates

Study start
2012
Primary completion
2012
Study completion
2013
First posted
Sep 29, 2015
Registry last updated
Sep 29, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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