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The effects of galactooligosaccharide (GOS) on peripheral insulin sensitivity and body weight control in obese adults with impaired glucose homeostasis

The effects of galactooligosaccharide (GOS) on peripheral insulin sensitivity and body weight control in obese adults with impaired glucose homeostasis - GOS and human substrate and energy metabolism

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON40698
Enrollment
46
Registered
2014-09-08
Start date
2014-11-24
Completion date
Unknown
Last updated
2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

insulin resistance overweight

Interventions

The subjects will be divided in 2 intervention groups: 1. 1. GOS: Domo® Vivinal® galacto-oligosaccharide rich whey product 5g 3x per day (269.6kjoule/day) 2. Placebo: Maltodextrin 5.65g 3xper day (2

Sponsors

Universiteit Maastricht
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Overweight/obese (BMI * 28 kg/m2

Exclusion criteria

Exclusion criteria: Subjects will be excluded from participation when one or more of the following aspects are present: - diabetes mellitus - gastroenterological diseases or major abdominal surgery (allowed i.e.: appendectomy, cholecystectomy) - lactose intolerance and other digestive disorders - cardiovascular disease, cancer, liver or kidney malfunction (determined based on ALAT and creatinine levels, respectively) - disease with a life expectancy shorter than 5 years - abuse of products (alcohol consumption > 15 units/week, or any drugs) - excessive nicotine use defined as >20 cigarettes per day - plans to lose weight or follow a hypocaloric diet - regular supplement of pre- or probiotic products - intensive exercise more than three hours a week - - use of any medication that influences glucose or fat metabolism and inflammation, like i.e. *-blockers, lipid lowering-drugs (e.g. PPAR * or PPAR* (fibrates) agonists), glucose-lowering agents (including all sulfonylureas, biguanides, *-glucosidase inhibitors, thiazolidinediones, repaglinide, nateglinide and insulin), anti-oxidants or chronic corticosteroids treatment. - use of laxation products in the last three months or during the study period;- use of antibiotics in the last three months or during the study period.

Design outcomes

Primary

MeasureTime frame
Primary endpoint: whole-body insulin sensitivity as assessed by a one-step hyperinsulinemic euglycemic clamp

Secondary

MeasureTime frame
- energy expenditure and substrate oxidation (indirect calorimetry) - adipose tissue and skeletal muscle gene/protein expression - faecal and circulating SCFA - faecal microbiota composition - circulating incretins, metabolites and inflammatory parameters - body weight, BMI and body composition (DEXA scan) - volatile organic compounds (VOCs) in exhaled air

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)