The Effect of Whey Protein and Dietary Fibers on Risk Markers of the Metabolic Syndrome and Bone Health

Summary

The prevalence of overweight and lifestyle related diseases such as cardiovascular disease (CVD) and type 2 diabetes (T2D) is increasing world wide. The metabolic syndrome (MeS) is a condition characterized by abdominal obesity, high blood lipids, high blood pressure and elevated blood sugar. MeS is associated with an increased risk of developing CVD and T2D. Dietary fibers and whey protein have independently shown beneficial effects on several of these risk factors in previous studies. Whey protein is furthermore seen to show positive effects on bone turnover.

The purpose of this trial is to investigate whether an increased intake of dietary fibers and whey protein (separately or combined) over a period of 12 weeks will affect the risk markers of MeS and bone turnover in abdominally obese subjects.

A total of 80 people with abdominal obesity will be included. The design is a randomized, double blinded, controlled dietary intervention trial. Subjects are assigned to one of four experimental groups. Each group are provided with test products containing either high or low whey protein and high or low dietary fibers to replace part of their regular diet. The subjects are instructed in how to incorporate the test products in their habitual diets in order to maintain weight stability.

The primary outcome is postprandial lipaemia (PPL) - an independent risk factor of developing CVD. PPL is estimated by performing a standardized high fat meal test during which postprandial level of triglycerides is measured. The authors hypothesize that a diet of high content of whey protein and high dietary fiber during 12 weeks will induce a reduction in PPL.

Conditions

• Abdominal Obesity
• Metabolic Syndrome
• Type 2 Diabetes
• Cardiovascular Disease

Interventions

OTHER

Whey protein powder

60 g of whey protein powder

OTHER

Maltodextrin powder

60 g of Maltodextrin powder

OTHER

High fiber bread

Wheat bread with high content of dietary fibers (approximately 30 g fibers/day)

OTHER

Low fiber bread

Wheat bread with low content of dietary fibers (approximately 10 g fibers/day)

Sponsors & Collaborators

• University of Aarhus

  collaborator OTHER

• Rigshospitalet, Denmark

  collaborator OTHER

• University of California, Davis

  collaborator OTHER

• University of Copenhagen

  collaborator OTHER

• Aarhus University Hospital

  lead OTHER

Principal Investigators

• Søren Gregersen, MD, ph.d. · Aarhus University Hospital

• Knud Erik B. Knudsen, Professor · Department of Animal Science, University of Aarhus

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Model

FACTORIAL

Eligibility

Min Age

40 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2016-05-31

Primary Completion

2017-06-29

Completion

2017-06-29

Countries

• Denmark

Study Locations