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

Aarhus University Hospital

Status: Completed

Conditions: Abdominal Obesity; Type 2 Diabetes; Metabolic Syndrome; Cardiovascular Disease

Treatments: Other: Maltodextrin powder; Other: Low fiber bread; Other: Whey protein powder; Other: High fiber bread

Study type: Interventional

Funder types: Other

Identifiers

NCT02931630

MERITS

Details and patient eligibility

About

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.

Full description

Please refer to summary

Enrollment: 72 patients

Sex: All

Ages: 40+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Waist circumference ≥ 80 cm (women)/94 cm (men)
• Age ≥40 years

Exclusion criteria

• Significant cardiovascular, renal or endocrine disease
• History of diabetes
• ≥ 3 kg of weight gain or loss within the last 3 months
• Any change in medication within the last month
• Treatment with steroids
• Pregnancy, breastfeeding or planned pregnancy
• Psychiatric history
• Alcohol or drug addiction
• Dietary fiber supplement within the last month

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Triple Blind

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72 participants in 4 patient groups

HP/HF

Experimental group

Description:

Whey protein powder / High fiber bread

Treatment:

Other: High fiber bread

Other: Whey protein powder

HP/LF

Experimental group

Description:

Whey protein powder / Low fiber bread

Treatment:

Other: Low fiber bread

Other: Maltodextrin powder

LP/HF

Experimental group

Description:

Maltodextrin powder / High fiber bread

Treatment:

Other: High fiber bread

Other: Maltodextrin powder

LP/LF

Experimental group

Description:

Maltodextrin powder / Low fiber bread

Treatment:

Other: Low fiber bread

Other: Whey protein powder