Effect of Prebiotic and PUFA on the Gut Microbiota and Metabolic Risk Markers

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-08-31

Study Completion Date

2015-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The main objective of this study is to investigate in detail how a high-(prebiotic)fibre diet and a high-PUFA diet affect the gut microbiota composition in a metabolic challenged population, and if the diet-induced modulation of the gut microbiota mediates changes in metabolic risk markers.

Intake of both experimental diets over 4 weeks are expected to induce beneficial changes in the gut microbiota composition and to affect markers for insulin sensitivity, lipid metabolism and inflammation. The investigators hypothesize that the effect of both interventions on the metabolic risk markers will be partly mediated by the diet-induced changes in the gut microbiota composition.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Prebiotics as a Means to Modulate Gut Fermentation, Metabolism, Appetite and Cognition

NCT01718431

Metabolic Syndrome

COMPLETED EARLY_PHASE1

Promoting Gastrointestinal Health and Reducing Subclinical Inflammation in Obese Individuals

NCT02602496

Obesity Overweight

COMPLETED NA

The Effect of Fatty Acid Composition on Energy Intake and Satiety

NCT00242021

Obesity

COMPLETED NA

Effects of Polyunsaturated Fatty Acids on Intestinal Lipid Metabolism in Insulin-resistant Men

NCT01934543

Metabolic Syndrome

COMPLETED NA

Flax Mucilage and Apparent Nutrient Digestibility

NCT00953004

Obesity

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Overweight

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

High fibre diet (wheat bran extract)

Group Type EXPERIMENTAL

Wheat bran extract

Intervention Type DIETARY_SUPPLEMENT

Patients will be provided with 15g of wheat bran extract (WBE) (Cargill R\&D Centre Europe).

High PUFA diet (fish oil supplement)

Group Type EXPERIMENTAL

Fish oil

Intervention Type DIETARY_SUPPLEMENT

Patients will be provided with a fish oil supplement (capsules), containing 3-4g of N-3 fatty acids (Axellus A/S, Ishøj, Denmark).

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Wheat bran extract

Patients will be provided with 15g of wheat bran extract (WBE) (Cargill R\&D Centre Europe).

Intervention Type DIETARY_SUPPLEMENT

Fish oil

Patients will be provided with a fish oil supplement (capsules), containing 3-4g of N-3 fatty acids (Axellus A/S, Ishøj, Denmark).

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* BMI: 25-40 kg/m2
* Non-smoking
* Indices of the Metabolic Syndrome defined by the International Diabetes Federation (IDF 2006):

Central obesity (waist circumference; men: ≥94 cm and women: ≥80 cm) + any one of the following; raised triglyceride level (≥1.7 mmol/L), reduced HDL cholesterol (men: \<1.03 mmol/L, women: \<1.29 mmol/L), raised BP (systolic ≥130 mm Hg or diastolic ≥85 mm Hg) or raised fasting plasma glucose (≥5.6 mmol/L).

Exclusion Criteria

* Use of antibiotics
* Weight change \>3 kg 2 months prior to study start
* Intensive physical training/ elite athlete
* Medication for dyslipidemia, type 2 diabetes or elevated blood pressure
* Dietary supplements with pro/prebiotics, dietary fibre or fish oil supplement
* Lactation, pregnancy or planning of pregnancy during the study
* Gastro intestinal and liver disorders
* Chronic inflammatory disorders
* Diagnosed psychiatric disorder including treatment required depression
* Surgical treatment of obesity and abdominal surgery

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No