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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02931630
Other study ID # MERITS
Secondary ID
Status Completed
Phase N/A
First received August 19, 2016
Last updated July 13, 2017
Start date May 2016
Est. completion date June 29, 2017

Study information

Verified date July 2017
Source Aarhus University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

Please refer to summary


Recruitment information / eligibility

Status Completed
Enrollment 72
Est. completion date June 29, 2017
Est. primary completion date June 29, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 40 Years and older
Eligibility 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

Study Design


Intervention

Other:
Whey protein powder
60 g of whey protein powder
Maltodextrin powder
60 g of Maltodextrin powder
High fiber bread
Wheat bread with high content of dietary fibers (approximately 30 g fibers/day)
Low fiber bread
Wheat bread with low content of dietary fibers (approximately 10 g fibers/day)

Locations

Country Name City State
Denmark Aarhus University Hospital, Dep. of clinical nutrition research Aarhus

Sponsors (5)

Lead Sponsor Collaborator
Aarhus University Hospital Rigshospitalet, Denmark, University of Aarhus, University of California, Davis, University of Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Meal test: -15, 0, 60, 90, 120, 240, 360 min. Performed at baseline and at 12 weeks.
Secondary 24 hours blood pressure (BP) Arteriograph 24, TensioMed, Hungary Performed at baseline and week 12
Secondary 24 hours augmentation Index (AI) Arteriograph 24, TensioMed, Hungary Performed at baseline and week 12
Secondary Respiratory Exchange Ratio Measured twice during each meal test by indirect calorimetry (hood) Meal test: -30 and 140 min. Performed at baseline and week 12.
Secondary Body composition Dual Energy X-ray Absorptiometry (DEXA) scan: Total body fat percentage, lean mass percentage, gynoid and android fat percentage Performed at baseline and week 12
Secondary 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. Meal test: -15, 0, 60, 240, 360 min. Performed at baseline and at 12 weeks.
Secondary 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. Meal test: -15, -10, 0, 15, 30, 60, 90, 120, 240, 360 min. Performed at baseline and week 12
Secondary 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. Meal test: -15, -10, 0, 15, 30, 60, 90, 120, 240, 360 min. Performed at baseline and week 12
Secondary 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. Meal test: -15, -10, 0, 15, 30, 60, 90, 120, 240, 360 min. Performed at baseline and week 12
Secondary 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 Meal test: -15, -10, 0, 15, 30, 60, 90, 120, 240, 360 min. Performed at baseline and week 12
Secondary 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 Meal test: -15, -10, 0, 15, 30, 60, 90, 120, 240, 360 min. Performed at baseline and week 12
Secondary 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 Meal test: -15, -10, 0, 15, 30, 60, 90, 120, 240, 360 min. Performed at baseline and week 12
Secondary Ghrelin response during high-fat meal test Ghrelin response measured as fasting value and incremental Area Under the Curve (iAUC from -15 - 360 Meal test: -15, -10, 0, 15, 30, 60, 90, 120, 240, 360 min. Performed at baseline and week 12
Secondary 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 Meal test: -15, -10, 0, 15, 30, 60, 90, 120, 240, 360 min. Performed at baseline and week 12
Secondary Adiponectin response during high-fat meal test Adiponectin response measured as fasting value and incremental Area Under the Curve (iAUC from -15 - 360) Meal test: -15, 0, 15, 30, 60, 90, 120, 240, 360 min. Performed at baseline and week 12
Secondary 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) Meal test: -15, 0, 60, 90, 120, 240, 360 min. Performed at baseline and week 12
Secondary 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) Meal test: 0, 15, 30, 60, 90, 120, 240 min. Performed at baseline and week 12
Secondary 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) Meal test: 0, 15, 30, 60, 90, 120, 240 min. Performed at baseline and week 12
Secondary 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) Meal test: 0, 15, 30, 60, 90, 120, 240 min. Performed at baseline and week 12
Secondary 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) Meal test: 0, 15, 30, 60, 90, 120, 240 min. Performed at baseline and week 12
Secondary 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) Meal test: 0, 15, 30, 60, 90, 120, 240 min. Performed at baseline and week 12
Secondary 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) Meal test: 0, 15, 30, 60, 90, 120, 240 min. Performed at baseline and week 12
Secondary 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) Meal test: 0, 15, 30, 90, 240 min. Performed at baseline and week 12
Secondary Osteoprotegrin response during high-fat meal test Osteoprotegrin response measured as fasting value and incremental Area Under the Curve (iAUC from 0-240 min) Meal test: 0, 15, 30, 90, 240 min. Performed at baseline and week 12
Secondary Osteocalcin response during high-fat meal test Osteocalcin response measured as fasting value and incremental Area Under the Curve (iAUC from 0-240 min) Meal test: 0, 15, 30, 90, 240 min. Performed at baseline and week 12
Secondary 25-dihydroxy vitamin D Fasting value measured at baseline and week 12 Change from week 0 to week 12
Secondary Phosphate Fasting value measured at baseline and week 12 Change from week 0 to week 12
Secondary Magnesium Fasting value measured at baseline and week 12 Change from week 0 to week 12
Secondary Total cholesterol Fasting value measured at baseline and week 12 Change from week 0 to week 12
Secondary Low density lipoprotein (LDL) Fasting value measured at baseline and week 12 Change from week 0 to week 12
Secondary High density lipoprotein (HDL) Fasting value measured at baseline and week 12 Change from week 0 to week 12
Secondary Glucose response during oral glucose tolerance test (OGTT) Glucose measured as incremental Area Under the Curve (iAUC from -15 - 120 min) OGTT: -15, -10, 0, 30, 60, 90, 120 min. Performed at baseline and week 12
Secondary Insulin response during oral glucose tolerance test (OGTT) Insulin measured as incremental Area Under the Curve (iAUC from -15 - 120 min) OGTT: -15, -10, 0, 30, 60, 90, 120 min. Performed at baseline and week 12
Secondary Glucagon response during oral glucose tolerance test (OGTT) Glucagon measured as incremental Area Under the Curve (iAUC from -15 - 120 min) OGTT: -15, -10, 0, 30, 60, 90, 120 min. Performed at baseline and week 12
Secondary 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) OGTT: -15, -10, 0, 30, 60, 90, 120 min. Performed at baseline and week 12
Secondary 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) OGTT: -15, -10, 0, 30, 60, 90, 120 min. Performed at baseline and week 12
Secondary 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) OGTT: -15, -10, 0, 30, 60, 90, 120 min. Performed at baseline and week 12
Secondary Parathyroid hormone (PTH) response during oral glucose tolerance test (OGTT) PTH measured as incremental Area Under the Curve (iAUC from 0-90 min) OGTT: 0, 30, 90 min. Performed at baseline and week 12
Secondary C-telopeptide (CTX) response during oral glucose tolerance test (OGTT) CTX measured as incremental Area Under the Curve (iAUC from 0-90 min) OGTT: 0, 30, 90 min. Performed at baseline and week 12
Secondary 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) OGTT: 0, 30, 90 min. Performed at baseline and week 12
Secondary Osteoprotegrin response during oral glucose tolerance test (OGTT) Osteoprotegrin measured as incremental Area Under the Curve (iAUC from 0-90 min) OGTT: 0, 30, 90 min. Performed at baseline and week 12
Secondary Osteocalcin response during oral glucose tolerance test (OGTT) Osteocalcin measured as incremental Area Under the Curve (iAUC from 0-90 min) OGTT: 0, 30, 90 min. Performed at baseline and week 12
Secondary Waist and hip circumference. Waist and hip circumference in cm Change from week 0 to week 12
Secondary Body weight Body weight in kg Change from week 0 to week 12
Secondary Body Mass Index kg/m2 Change from week 0 to week 12
Secondary 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. Change from week 0 to week 12
Secondary 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. Change from week 0 to week 12
Secondary Urinary calcium Urinary calcium excretion measured in 24-hour urine samples collected at baseline and week 12 Change from week 0 to week 12
Secondary Urinary nitrogen Urinary nitrogen excretion measured in 24-hour urine samples collected at baseline and week 12 Change from week 0 to week 12
Secondary Metabolomics, plasma Non-targeted metabolomics analysis using Liquid Chromatography - Mass Spectrometry OGTT: -15, 30, 60, 90, 120 min. Performed at baseline and week 12.
Secondary Metabolomics, urine Non-targeted metabolomics analysis using Liquid Chromatography - Mass Spectrometry 24-hour urine collection performed at baseline and week 12.
Secondary Metabolomics, faeces Non-targeted metabolomics analysis using Liquid Chromatography - Mass Spectrometry Collected at baseline and week 12.
Secondary 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 OGTT performed at baseline and week 12 (blood sampling at -15, -10, 0, 30, 60, 90, 120 min)
Secondary Appetite assessment during high-fat meal test Visual Analog Scale (VAS) electronic questionnaire Meal test: Questionnaire at -10, 0, 30, 60, 90, 120, 180, 240, 300, 360 min. Performed at baseline and week 12.
Secondary Microbiota Non-targeted microbiome and metabolome analyses using high-throughput DNA sequencing on Illumina Miseq and Liquid Chromatography - Mass Spectrometry (LC-MS) metabolomics, Faecal samples collected at baseline and week 12.
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