Clinical trial NCT02931630: The Effect of Whey Protein and Dietary Fibers on Risk Markers of the Metabolic Syndrome and Bone Health
Official title: The Effect of Whey Protein and Dietary Fibers on Risk Markers of the Metabolic Syndrome and Bone Health
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Abdominal Obesity
Metabolic Syndrome
Type 2 Diabetes
Cardiovascular Disease
Keywords: Whey protein
Dietary fibers
Wheat bran
Arabinoxylan
Postprandial lipaemia
Body composition
Blood pressure
Metabolic rate
Insulin sensitivity
Metabolic syndrome
Lead sponsor: Aarhus University Hospital
Sponsor class: OTHER
Collaborators: name: University of Aarhus
name: Rigshospitalet, Denmark
name: University of California, Davis
name: University of Copenhagen
First posted: 2016-10-13
Enrollment: 72
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief 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.

Detailed description: Please refer to summary

Eligibility criteria: 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

Primary outcomes:
measure: Postprandial triglyceride response
timeFrame: Meal test: -15, 0, 60, 90, 120, 240, 360 min. Performed at baseline and at 12 weeks.
Secondary outcomes:
measure: 24 hours blood pressure (BP)
timeFrame: Performed at baseline and week 12
measure: 24 hours augmentation Index (AI)
timeFrame: Performed at baseline and week 12
measure: Respiratory Exchange Ratio
timeFrame: Meal test: -30 and 140 min. Performed at baseline and week 12.
measure: Body composition
timeFrame: Performed at baseline and week 12
measure: Postprandial apolipoprotein B48 response
timeFrame: Meal test: -15, 0, 60, 240, 360 min. Performed at baseline and at 12 weeks.
measure: Glucose response during high-fat meal test
timeFrame: Meal test: -15, -10, 0, 15, 30, 60, 90, 120, 240, 360 min. Performed at baseline and week 12
measure: Insulin response during high-fat meal test
timeFrame: Meal test: -15, -10, 0, 15, 30, 60, 90, 120, 240, 360 min. Performed at baseline and week 12
measure: Glucagon response during high-fat meal test
timeFrame: Meal test: -15, -10, 0, 15, 30, 60, 90, 120, 240, 360 min. Performed at baseline and week 12
measure: Glucagon-like peptide 1 (GLP-1) response during high-fat meal test
timeFrame: Meal test: -15, -10, 0, 15, 30, 60, 90, 120, 240, 360 min. Performed at baseline and week 12
measure: Glucagon-like peptide 2 (GLP-2) response during high-fat meal test
timeFrame: Meal test: -15, -10, 0, 15, 30, 60, 90, 120, 240, 360 min. Performed at baseline and week 12
measure: Glucose-dependent insulinotropic polypeptide (GIP) response during high-fat meal test
timeFrame: Meal test: -15, -10, 0, 15, 30, 60, 90, 120, 240, 360 min. Performed at baseline and week 12
measure: Ghrelin response during high-fat meal test
timeFrame: Meal test: -15, -10, 0, 15, 30, 60, 90, 120, 240, 360 min. Performed at baseline and week 12
measure: Peptide tyrosine tyrosine (PYY) response during high-fat meal test
timeFrame: Meal test: -15, -10, 0, 15, 30, 60, 90, 120, 240, 360 min. Performed at baseline and week 12
measure: Adiponectin response during high-fat meal test
timeFrame: Meal test: -15, 0, 15, 30, 60, 90, 120, 240, 360 min. Performed at baseline and week 12
measure: Non-esterified fatty acids (NEFA) response during high-fat meal test
timeFrame: Meal test: -15, 0, 60, 90, 120, 240, 360 min. Performed at baseline and week 12
measure: Interleukin-6 (IL-6) response during high-fat meal test
timeFrame: Meal test: 0, 15, 30, 60, 90, 120, 240 min. Performed at baseline and week 12
measure: Monocyte chemoattractant protein 1 (MCP-1) response during high-fat meal test
timeFrame: Meal test: 0, 15, 30, 60, 90, 120, 240 min. Performed at baseline and week 12
measure: RANTES (CCL5) response during high-fat meal test
timeFrame: Meal test: 0, 15, 30, 60, 90, 120, 240 min. Performed at baseline and week 12
measure: High-sensitive c-reactive protein (hs-CRP) response during high-fat meal test
timeFrame: Meal test: 0, 15, 30, 60, 90, 120, 240 min. Performed at baseline and week 12
measure: Procollagen type 1 N-terminal propeptide (P1NP) response during high-fat meal test
timeFrame: Meal test: 0, 15, 30, 60, 90, 120, 240 min. Performed at baseline and week 12
measure: C-telopeptide (CTX) response during high-fat meal test
timeFrame: Meal test: 0, 15, 30, 60, 90, 120, 240 min. Performed at baseline and week 12
measure: Parathyroid hormone (PTH) response during high-fat meal test
timeFrame: Meal test: 0, 15, 30, 90, 240 min. Performed at baseline and week 12
measure: Osteoprotegrin response during high-fat meal test
timeFrame: Meal test: 0, 15, 30, 90, 240 min. Performed at baseline and week 12
measure: Osteocalcin response during high-fat meal test
timeFrame: Meal test: 0, 15, 30, 90, 240 min. Performed at baseline and week 12
measure: 25-dihydroxy vitamin D
timeFrame: Change from week 0 to week 12
measure: Phosphate
timeFrame: Change from week 0 to week 12
measure: Magnesium
timeFrame: Change from week 0 to week 12
measure: Total cholesterol
timeFrame: Change from week 0 to week 12
measure: Low density lipoprotein (LDL)
timeFrame: Change from week 0 to week 12
measure: High density lipoprotein (HDL)
timeFrame: Change from week 0 to week 12
measure: Glucose response during oral glucose tolerance test (OGTT)
timeFrame: OGTT: -15, -10, 0, 30, 60, 90, 120 min. Performed at baseline and week 12
measure: Insulin response during oral glucose tolerance test (OGTT)
timeFrame: OGTT: -15, -10, 0, 30, 60, 90, 120 min. Performed at baseline and week 12
measure: Glucagon response during oral glucose tolerance test (OGTT)
timeFrame: OGTT: -15, -10, 0, 30, 60, 90, 120 min. Performed at baseline and week 12
measure: Glucagon-like peptide 1 (GLP-1) response during oral glucose tolerance test (OGTT)
timeFrame: OGTT: -15, -10, 0, 30, 60, 90, 120 min. Performed at baseline and week 12
measure: Glucagon-like peptide 2 (GLP-2) response during oral glucose tolerance test (OGTT)
timeFrame: OGTT: -15, -10, 0, 30, 60, 90, 120 min. Performed at baseline and week 12
measure: Glucose-dependent insulinotropic polypeptide (GIP) response during oral glucose tolerance test (OGTT)
timeFrame: OGTT: -15, -10, 0, 30, 60, 90, 120 min. Performed at baseline and week 12
measure: Parathyroid hormone (PTH) response during oral glucose tolerance test (OGTT)
timeFrame: OGTT: 0, 30, 90 min. Performed at baseline and week 12
measure: C-telopeptide (CTX) response during oral glucose tolerance test (OGTT)
timeFrame: OGTT: 0, 30, 90 min. Performed at baseline and week 12
measure: Procollagen type 1 N-terminal propeptide (P1NP) response during oral glucose tolerance test (OGTT)
timeFrame: OGTT: 0, 30, 90 min. Performed at baseline and week 12
measure: Osteoprotegrin response during oral glucose tolerance test (OGTT)
timeFrame: OGTT: 0, 30, 90 min. Performed at baseline and week 12
measure: Osteocalcin response during oral glucose tolerance test (OGTT)
timeFrame: OGTT: 0, 30, 90 min. Performed at baseline and week 12
measure: Waist and hip circumference.
timeFrame: Change from week 0 to week 12
measure: Body weight
timeFrame: Change from week 0 to week 12
measure: Body Mass Index
timeFrame: Change from week 0 to week 12
measure: Adipose tissue gene expression
timeFrame: Change from week 0 to week 12
measure: Adipose tissue proliferation and differentiation
timeFrame: Change from week 0 to week 12
measure: Urinary calcium
timeFrame: Change from week 0 to week 12
measure: Urinary nitrogen
timeFrame: Change from week 0 to week 12
measure: Metabolomics, plasma
timeFrame: OGTT: -15, 30, 60, 90, 120 min. Performed at baseline and week 12.
measure: Metabolomics, urine
timeFrame: 24-hour urine collection performed at baseline and week 12.
measure: Metabolomics, faeces
timeFrame: Collected at baseline and week 12.
measure: Insulin sensitivity during oral glucose tolerance test (OGTT)
timeFrame: OGTT performed at baseline and week 12 (blood sampling at -15, -10, 0, 30, 60, 90, 120 min)
measure: Appetite assessment during high-fat meal test
timeFrame: Meal test: Questionnaire at -10, 0, 30, 60, 90, 120, 180, 240, 300, 360 min. Performed at baseline and week 12.
measure: Microbiota
timeFrame: Faecal samples collected at baseline and week 12.
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University Hospital, Dep. of clinical nutrition research
Study officials:
affiliation: Aarhus University Hospital
name: Søren Gregersen, MD, ph.d.
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Animal Science, University of Aarhus
name: Knud Erik B. Knudsen, Professor
role: STUDY_CHAIR
References:
citation: Fuglsang-Nielsen R, Rakvaag E, Vestergaard P, Hermansen K, Gregersen S, Starup-Linde J. The Effects of 12-Weeks Whey Protein Supplements on Markers of Bone Turnover in Adults With Abdominal Obesity - A Post Hoc Analysis. Front Endocrinol (Lausanne). 2022 Mar 29;13:832897. doi: 10.3389/fendo.2022.832897. eCollection 2022.