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.
Please refer to summary
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
72
60 g of whey protein powder
60 g of Maltodextrin powder
Wheat bread with high content of dietary fibers (approximately 30 g fibers/day)
Wheat bread with low content of dietary fibers (approximately 10 g fibers/day)
Aarhus University Hospital, Dep. of clinical nutrition research
Aarhus, Denmark
Postprandial triglyceride response
Postprandial triglyceride response measured as fasting value and incremental Area Under the Curve (iAUC from -15 - 360 min) following a high-fat meal.
Time frame: Meal test: -15, 0, 60, 90, 120, 240, 360 min. Performed at baseline and at 12 weeks.
24 hours blood pressure (BP)
Arteriograph 24, TensioMed, Hungary
Time frame: Performed at baseline and week 12
24 hours augmentation Index (AI)
Arteriograph 24, TensioMed, Hungary
Time frame: Performed at baseline and week 12
Respiratory Exchange Ratio
Measured twice during each meal test by indirect calorimetry (hood)
Time frame: Meal test: -30 and 140 min. Performed at baseline and week 12.
Body composition
Dual Energy X-ray Absorptiometry (DEXA) scan: Total body fat percentage, lean mass percentage, gynoid and android fat percentage
Time frame: Performed at baseline and week 12
Postprandial apolipoprotein B48 response
Postprandial apolipoprotein response measured as fasting value and incremental Area Under the Curve (iAUC from -15 - 360 min) following a high-fat meal.
Time frame: Meal test: -15, 0, 60, 240, 360 min. Performed at baseline and at 12 weeks.
Glucose response during high-fat meal test
Glucose response measured as fasting value and incremental Area Under the Curve (iAUC from -15 - 360 min) following a high-fat meal.
Time frame: Meal test: -15, -10, 0, 15, 30, 60, 90, 120, 240, 360 min. Performed at baseline and week 12
Insulin response during high-fat meal test
Insulin response measured as fasting value and incremental Area Under the Curve (iAUC from -15 - 360 min) following a high-fat meal.
Time frame: Meal test: -15, -10, 0, 15, 30, 60, 90, 120, 240, 360 min. Performed at baseline and week 12
Glucagon response during high-fat meal test
Glukagon response measured as fasting value and incremental Area Under the Curve (iAUC from -15 - 360 min) following a high-fat meal.
Time frame: Meal test: -15, -10, 0, 15, 30, 60, 90, 120, 240, 360 min. Performed at baseline and week 12
Glucagon-like peptide 1 (GLP-1) response during high-fat meal test
GLP-1 response measured as fasting value and incremental Area Under the Curve (iAUC from -15 - 360
Time frame: Meal test: -15, -10, 0, 15, 30, 60, 90, 120, 240, 360 min. Performed at baseline and week 12
Glucagon-like peptide 2 (GLP-2) response during high-fat meal test
GLP-2 response measured as fasting value and incremental Area Under the Curve (iAUC from -15 - 360
Time frame: Meal test: -15, -10, 0, 15, 30, 60, 90, 120, 240, 360 min. Performed at baseline and week 12
Glucose-dependent insulinotropic polypeptide (GIP) response during high-fat meal test
GIP response measured as fasting value and incremental Area Under the Curve (iAUC from -15 - 360
Time frame: Meal test: -15, -10, 0, 15, 30, 60, 90, 120, 240, 360 min. Performed at baseline and week 12
Ghrelin response during high-fat meal test
Ghrelin response measured as fasting value and incremental Area Under the Curve (iAUC from -15 - 360
Time frame: Meal test: -15, -10, 0, 15, 30, 60, 90, 120, 240, 360 min. Performed at baseline and week 12
Peptide tyrosine tyrosine (PYY) response during high-fat meal test
PYY response measured as fasting value and incremental Area Under the Curve (iAUC from -15 - 360
Time frame: Meal test: -15, -10, 0, 15, 30, 60, 90, 120, 240, 360 min. Performed at baseline and week 12
Adiponectin response during high-fat meal test
Adiponectin response measured as fasting value and incremental Area Under the Curve (iAUC from -15 - 360)
Time frame: Meal test: -15, 0, 15, 30, 60, 90, 120, 240, 360 min. Performed at baseline and week 12
Non-esterified fatty acids (NEFA) response during high-fat meal test
NEFA response measured as fasting value and incremental Area Under the Curve (iAUC from -15 - 360)
Time frame: Meal test: -15, 0, 60, 90, 120, 240, 360 min. Performed at baseline and week 12
Interleukin-6 (IL-6) response during high-fat meal test
IL-6 response measured as fasting value and incremental Area Under the Curve (iAUC from 0-240 min)
Time frame: Meal test: 0, 15, 30, 60, 90, 120, 240 min. Performed at baseline and week 12
Monocyte chemoattractant protein 1 (MCP-1) response during high-fat meal test
MCP-1 response measured as fasting value and incremental Area Under the Curve (iAUC from 0 - 240 min)
Time frame: Meal test: 0, 15, 30, 60, 90, 120, 240 min. Performed at baseline and week 12
RANTES (CCL5) response during high-fat meal test
CCL5 response measured as fasting value and incremental Area Under the Curve (iAUC from 0-240 min)
Time frame: Meal test: 0, 15, 30, 60, 90, 120, 240 min. Performed at baseline and week 12
High-sensitive c-reactive protein (hs-CRP) response during high-fat meal test
hs-CRP response measured as fasting value and incremental Area Under the Curve (iAUC from 0-240 min)
Time frame: Meal test: 0, 15, 30, 60, 90, 120, 240 min. Performed at baseline and week 12
Procollagen type 1 N-terminal propeptide (P1NP) response during high-fat meal test
P1NP response measured as fasting value and incremental Area Under the Curve (iAUC from 0-240 min)
Time frame: Meal test: 0, 15, 30, 60, 90, 120, 240 min. Performed at baseline and week 12
C-telopeptide (CTX) response during high-fat meal test
CTX response measured as fasting value and incremental Area Under the Curve (iAUC from 0-240 min)
Time frame: Meal test: 0, 15, 30, 60, 90, 120, 240 min. Performed at baseline and week 12
Parathyroid hormone (PTH) response during high-fat meal test
PTH response measured as fasting value and incremental Area Under the Curve (iAUC from 0-240 min)
Time frame: Meal test: 0, 15, 30, 90, 240 min. Performed at baseline and week 12
Osteoprotegrin response during high-fat meal test
Osteoprotegrin response measured as fasting value and incremental Area Under the Curve (iAUC from 0-240 min)
Time frame: Meal test: 0, 15, 30, 90, 240 min. Performed at baseline and week 12
Osteocalcin response during high-fat meal test
Osteocalcin response measured as fasting value and incremental Area Under the Curve (iAUC from 0-240 min)
Time frame: Meal test: 0, 15, 30, 90, 240 min. Performed at baseline and week 12
25-dihydroxy vitamin D
Fasting value measured at baseline and week 12
Time frame: Change from week 0 to week 12
Phosphate
Fasting value measured at baseline and week 12
Time frame: Change from week 0 to week 12
Magnesium
Fasting value measured at baseline and week 12
Time frame: Change from week 0 to week 12
Total cholesterol
Fasting value measured at baseline and week 12
Time frame: Change from week 0 to week 12
Low density lipoprotein (LDL)
Fasting value measured at baseline and week 12
Time frame: Change from week 0 to week 12
High density lipoprotein (HDL)
Fasting value measured at baseline and week 12
Time frame: Change from week 0 to week 12
Glucose response during oral glucose tolerance test (OGTT)
Glucose measured as incremental Area Under the Curve (iAUC from -15 - 120 min)
Time frame: OGTT: -15, -10, 0, 30, 60, 90, 120 min. Performed at baseline and week 12
Insulin response during oral glucose tolerance test (OGTT)
Insulin measured as incremental Area Under the Curve (iAUC from -15 - 120 min)
Time frame: OGTT: -15, -10, 0, 30, 60, 90, 120 min. Performed at baseline and week 12
Glucagon response during oral glucose tolerance test (OGTT)
Glucagon measured as incremental Area Under the Curve (iAUC from -15 - 120 min)
Time frame: OGTT: -15, -10, 0, 30, 60, 90, 120 min. Performed at baseline and week 12
Glucagon-like peptide 1 (GLP-1) response during oral glucose tolerance test (OGTT)
GLP-1 measured as incremental Area Under the Curve (iAUC from -15 - 120 min)
Time frame: OGTT: -15, -10, 0, 30, 60, 90, 120 min. Performed at baseline and week 12
Glucagon-like peptide 2 (GLP-2) response during oral glucose tolerance test (OGTT)
GLP-2 measured as incremental Area Under the Curve (iAUC from -15 - 120 min)
Time frame: OGTT: -15, -10, 0, 30, 60, 90, 120 min. Performed at baseline and week 12
Glucose-dependent insulinotropic polypeptide (GIP) response during oral glucose tolerance test (OGTT)
GIP measured as incremental Area Under the Curve (iAUC from -15 - 120 min)
Time frame: OGTT: -15, -10, 0, 30, 60, 90, 120 min. Performed at baseline and week 12
Parathyroid hormone (PTH) response during oral glucose tolerance test (OGTT)
PTH measured as incremental Area Under the Curve (iAUC from 0-90 min)
Time frame: OGTT: 0, 30, 90 min. Performed at baseline and week 12
C-telopeptide (CTX) response during oral glucose tolerance test (OGTT)
CTX measured as incremental Area Under the Curve (iAUC from 0-90 min)
Time frame: OGTT: 0, 30, 90 min. Performed at baseline and week 12
Procollagen type 1 N-terminal propeptide (P1NP) response during oral glucose tolerance test (OGTT)
P1NP measured as incremental Area Under the Curve (iAUC from 0-90 min)
Time frame: OGTT: 0, 30, 90 min. Performed at baseline and week 12
Osteoprotegrin response during oral glucose tolerance test (OGTT)
Osteoprotegrin measured as incremental Area Under the Curve (iAUC from 0-90 min)
Time frame: OGTT: 0, 30, 90 min. Performed at baseline and week 12
Osteocalcin response during oral glucose tolerance test (OGTT)
Osteocalcin measured as incremental Area Under the Curve (iAUC from 0-90 min)
Time frame: OGTT: 0, 30, 90 min. Performed at baseline and week 12
Waist and hip circumference.
Waist and hip circumference in cm
Time frame: Change from week 0 to week 12
Body weight
Body weight in kg
Time frame: Change from week 0 to week 12
Body Mass Index
kg/m2
Time frame: Change from week 0 to week 12
Adipose tissue gene expression
Subcutaneous fat tissue biopsy performed at baseline and week 12 for the measurement of changes in genes related to lipid and glucose metabolism and insulin signalling.
Time frame: Change from week 0 to week 12
Adipose tissue proliferation and differentiation
Subcutaneous fat tissue biopsy performed at baseline and week 12 for measuring proliferation and differentiation processes of preadipocyte stem cells into mature adipocytes, and to test the effect of diets on expanding the capacity of the subcutaneous adipose tissue to store fat.
Time frame: Change from week 0 to week 12
Urinary calcium
Urinary calcium excretion measured in 24-hour urine samples collected at baseline and week 12
Time frame: Change from week 0 to week 12
Urinary nitrogen
Urinary nitrogen excretion measured in 24-hour urine samples collected at baseline and week 12
Time frame: Change from week 0 to week 12
Metabolomics, plasma
Non-targeted metabolomics analysis using Liquid Chromatography - Mass Spectrometry
Time frame: OGTT: -15, 30, 60, 90, 120 min. Performed at baseline and week 12.
Metabolomics, urine
Non-targeted metabolomics analysis using Liquid Chromatography - Mass Spectrometry
Time frame: 24-hour urine collection performed at baseline and week 12.
Metabolomics, faeces
Non-targeted metabolomics analysis using Liquid Chromatography - Mass Spectrometry
Time frame: Collected at baseline and week 12.
Insulin sensitivity during oral glucose tolerance test (OGTT)
Homeostasis model assessment - insulin resistance (HOMA-IR) and Matsuda Index calculated based on blood glucose and insulin measurements during OGTT
Time frame: OGTT performed at baseline and week 12 (blood sampling at -15, -10, 0, 30, 60, 90, 120 min)
Appetite assessment during high-fat meal test
Visual Analog Scale (VAS) electronic questionnaire
Time frame: Meal test: Questionnaire at -10, 0, 30, 60, 90, 120, 180, 240, 300, 360 min. Performed at baseline and week 12.
Microbiota
Non-targeted microbiome and metabolome analyses using high-throughput DNA sequencing on Illumina Miseq and Liquid Chromatography - Mass Spectrometry (LC-MS) metabolomics,
Time frame: Faecal samples collected at baseline and week 12.
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