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

Type 2 Diabetes Clinical Trial

— MERITS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02931630
• Other study ID #: MERITS
• 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
• 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

Related Conditions & MeSH terms

• Abdominal Obesity
• Cardiovascular Disease
• Cardiovascular Diseases
• Metabolic Syndrome
• Metabolic Syndrome X
• Obesity, Abdominal
• Syndrome
• Type 2 Diabetes

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.