Role of Colonic Events on Metabolism and Appetite Control: A Synbiotic Approach

NCT01718418 | Completed Early Phase 1

• 1 other identifier: Dnr2010/457
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to evaluate food factors related to colonically derived regulation of glucose metabolism (and related parameters) and satiety using a semi-acute meal study in healthy subjects as experimental model.

Conditions

Obesity; Metabolic Syndrome

Outcome Measures

Primary Outcomes (1)

• Differences in concentration of risk markers in blood, measured post-prandial after a breakfast meal.

  Variables (blood glucose, insulin, incretin, inflammatory markers, markers of colonic fermentation) are measured after two-weeks ingestion of test products. The experimental day is terminated after a lunch meal.

  Post-prandially after breakfast, 0-210 min

Secondary Outcomes (3)

• voluntary energy intake

  Post-prandially after breakfast, 0-210 min

• Subjective satiety

  post-prandially after breakfast, 0-210 min

• Differences in gut microbiota

  Faecal samples are collected after 14 days intake of test- and reference product

Study Arms (3)

+ ind.CHO + prebiotics

EXPERIMENTAL

test meal: intrinsic indigestible carbohydrates in combination with a combined probiotic supplement.

Other: test meal

+ ind.CHO - prebiotics

EXPERIMENTAL

test meal: intrinsic indigestible carbohydrates in combination with placebo probiotic supplement.

Other: test meal

- ind.CHO - prebiotics

EXPERIMENTAL

reference: no ind. carbohydrates and no probiotic supplement

Other: reference

Interventions

test meal OTHER

+ ind.CHO + prebiotics; + ind.CHO - prebiotics

reference OTHER

- ind.CHO - prebiotics

Eligibility Criteria

• Age: 20 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Normal fasting blood glucose, BMI 19-25 kg/m2, for women: hormon based contraceptives

You may not qualify if:

• gastrointestinal diseases or food allergies e.g. lactose-, gluten intolerance, metabolic disorders e.g. diabetes, tobacco/snuff users. Antibiotic or probiotic usage within two weeks, and during the study. Vegetarians

Sponsors & Collaborators

• Lund University: lead

Study Sites (1)

Applied Nutrition and Food Chemistry, Lund University

Lund, SE-221 00, Sweden

Location

Related Publications (1)

• Nilsson A, Johansson-Boll E, Sandberg J, Bjorck I. Gut microbiota mediated benefits of barley kernel products on metabolism, gut hormones, and inflammatory markers as affected by co-ingestion of commercially available probiotics: a randomized controlled study in healthy subjects. Clin Nutr ESPEN. 2016 Oct;15:49-56. doi: 10.1016/j.clnesp.2016.06.006. Epub 2016 Jul 2.

  PMID: 28531784 DERIVED

MeSH Terms

Conditions

Obesity; Metabolic Syndrome

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases

Study Officials

• Anne Nilsson, PhD

  Lund University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MSc, post-graduate student

Study Record Dates

• First Submitted: October 9, 2012
• First Posted: October 31, 2012
• Study Start: September 1, 2012
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: May 8, 2013

Record last verified: 2013-05

Locations

SE (1)