Fiber and Insulin Sensitivity

Obesity Clinical Trial

Official title:

Gut Microbial Substrate Switch to Improve Metabolic Health

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04714944
• Other study ID #: NL72483.068.20
• Status: Completed
• Phase: N/A
• Start date: February 5, 2021
• Est. completion date: March 29, 2023

Study information

• Verified date: March 2023
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Based on previous research of the investigators group, the investigators hypothesize that slowly fermentable fibers with a high degree of polymerization that increase SCFA specifically in the distal colon are expected to have higher potential for influencing host metabolism and metabolic health by improving adipose tissue function, preventing lipid overflow and hepatic as well as skeletal muscle fat accumulation thereby improving insulin sensitivity.

The objective of this randomized clinical trial is to test, whether the a dietary fiber product containing different physiological acting fibers reverses peripheral and hepatic insulin resistance in overweight/obese insulin resistant participants.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: March 29, 2023
• Est. primary completion date: March 29, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 70 Years

Eligibility

Inclusion criteria:

Overweight/obese insulin resistant/prediabetic participants (age 45-70 y, BMI = 28 kg/m2 < 35 kg/m2)

Exclusion criteria:

• Type 2 diabetes mellitus (defined as fasting plasma glucose = 7.0 mmol/L and 2h glucose = 11.1 mmol/L)

• Gastroenterological diseases or abdominal surgery;

• Cardiovascular diseases, cancer, liver or kidney malfunction, disease with a life expectancy shorter than 5 years;

• Abuse of products; alcohol and drugs, excessive nicotine use defined as >20 cigarettes per day;

• Plans to lose weight or following of a hypocaloric diet;

• Regular supplementation of pre- or probiotic products, use of pre- or probiotics 3 months prior to the start of the study;

• Intensive exercise training more than three hours a week;

• Use of any medication that influences glucose or fat metabolism and inflammation (i.e. NSAIDs);

• Regular use of laxation products;

• Use of antibiotics in the last three months (antibiotics use can alter substantially the gut microbiota composition).

• Follow a vegetarian diet.

• Metal objects such as implants present in the body (e.g. electronic implants, pacemakers, metal fragments in the eyes, skin or body)

• The use of permanent make-up (eyeliners, eyebrows) or tattoos on the head, shoulders, breast or neck

• Claustrophobia

Related Conditions & MeSH terms

• Insulin Resistance
• Obesity

Intervention

Dietary Supplement:
• Placebo
Supplementation period 12 weeks
• Whole fiber product
Supplementation period 12 weeks

Locations

Country	Name	City	State
Netherlands	Maastricht University	Maastricht	Limburg

Sponsors (1)

Lead Sponsor	Collaborator
Maastricht University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peripheral insulin sensitivity	The change of peripheral insulin sensitivity as assessed by a hyperinsulinaemic-euglycemic clamp	Before and 12 week after the start of the intervention
Secondary	hepatic and adipose tissue insulin sensitivity	The change in hepatic and adipose tissue insulin sensitivity as assessed by a hyperinsulinaemic-euglycemic clamp	Before and 12 week after the start of the intervention
Secondary	Energy expenditure (indirect calorimetry)	The change in energy expenditure as measured via ventilated hood system	Before and 12 week after the start of the intervention
Secondary	Substrate oxidation (indirect calorimetry)	The change in substrate oxidation as measured via ventilated hood system	Before and 12 week after the start of the intervention
Secondary	Faecal and circulating SCFA	The change in faecal and circulating SCFA	Before and 12 week after the start of the intervention
Secondary	Faecal microbiota composition and in vitro microbial activity testing	The change in faecal microbiota composition as assessed via 16s rRNA gene sequencing	Before and 12 week after the start of the intervention
Secondary	In vitro microbial activity testing	The change in fin vitro microbial activity testing as assessed using an in vitro model of the human colon	Before and 12 week after the start of the intervention
Secondary	Circulating hormones such as insulin	The change in circulating hormones in peripheral blood	Before and 12 week after the start of the intervention
Secondary	Circulating metabolites such as glucose	The change in metabolites in peripheral blood	Before and 12 week after the start of the intervention
Secondary	Circulating inflammatory markers such as TNF	The change in inflammatory markers in peripheral blood	Before and 12 week after the start of the intervention
Secondary	body weight	The change in body weight in kg	Before and 12 week after the start of the intervention
Secondary	body composition	The change in body compostion as assessed using DEXA scans	Before and 12 week after the start of the intervention
Secondary	liver fat content	The change in liver fat content as assessed by proton magnetic resonance spectrometry	Before and 12 week after the start of the intervention