Abdominal ObesityMERITSNCT02931630
The Effect of Whey Protein and Dietary Fibers on Risk Markers of the Metabolic Syndrome and Bone Health
A study testing Whey protein powder, Maltodextrin powder and High fiber bread in people with Abdominal Obesity and Metabolic Syndrome, run by Aarhus University Hospital at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Abdominal Obesity, Metabolic Syndrome, Type 2 Diabetes
- What is being tested?
- Whey protein powder, Maltodextrin powder and High fiber bread
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteDenmark
- Study dates
- May 2016to 29 Jun 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Waist circumference ≥ 80 cm (women)/94 cm (men)
- Age ≥40 years
Who cannot join
- 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
Show all 9Show fewer
- Psychiatric history
- Alcohol or drug addiction
- Dietary fiber supplement within the last month
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Aarhus University Hospital, Dep. of clinical nutrition research
Aarhus, 8000
About this study
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.
Read more
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.
Read the detailed description
Please refer to summary
- Being tested
- Whey protein powder, Maltodextrin powder, High fiber bread, Low fiber bread
- Keywords
- Whey protein, Dietary fibers, Wheat bran, Arabinoxylan, Postprandial lipaemia, Body composition, Blood pressure, Metabolic rate, Insulin sensitivity, Metabolic syndrome
- Medical subject headings
- Obesity, Abdominal, Metabolic Syndrome, Diabetes Mellitus, Type 2, Cardiovascular Diseases, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whey protein powderOther
60 g of whey protein powder
Maltodextrin powderOther
60 g of Maltodextrin powder
High fiber breadOther
Wheat bread with high content of dietary fibers (approximately 30 g fibers/day)
Low fiber breadOther
Wheat bread with low content of dietary fibers (approximately 10 g fibers/day)
| Study group | Role | What they receive |
|---|---|---|
| HP/HF | Experimental | Whey protein powder / High fiber bread Receives: Other: Whey protein powder; Other: High fiber bread |
| HP/LF | Experimental | Whey protein powder / Low fiber bread Receives: Other: Maltodextrin powder; Other: Low fiber bread |
| LP/HF | Experimental | Maltodextrin powder / High fiber bread Receives: Other: Maltodextrin powder; Other: High fiber bread |
| LP/LF | Experimental | Maltodextrin powder / Low fiber bread Receives: Other: Whey protein powder; Other: Low fiber bread |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Meal test: -15, 0, 60, 90, 120, 240, 360 min. Performed at baseline and at 12 weeks.
Secondary outcomes (54)
24 hours blood pressure (BP)
Arteriograph 24, TensioMed, Hungary
Measured: Performed at baseline and week 12
24 hours augmentation Index (AI)
Arteriograph 24, TensioMed, Hungary
Measured: Performed at baseline and week 12
Respiratory Exchange Ratio
Measured twice during each meal test by indirect calorimetry (hood)
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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
Measured: Change from week 0 to week 12
Phosphate
Fasting value measured at baseline and week 12
Measured: Change from week 0 to week 12
Magnesium
Fasting value measured at baseline and week 12
Measured: Change from week 0 to week 12
Total cholesterol
Fasting value measured at baseline and week 12
Measured: Change from week 0 to week 12
Low density lipoprotein (LDL)
Fasting value measured at baseline and week 12
Measured: Change from week 0 to week 12
High density lipoprotein (HDL)
Fasting value measured at baseline and week 12
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: OGTT: 0, 30, 90 min. Performed at baseline and week 12
Waist and hip circumference.
Waist and hip circumference in cm
Measured: Change from week 0 to week 12
Body weight
Body weight in kg
Measured: Change from week 0 to week 12
Body Mass Index
kg/m2
Measured: 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.
Measured: 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.
Measured: Change from week 0 to week 12
Urinary calcium
Urinary calcium excretion measured in 24-hour urine samples collected at baseline and week 12
Measured: Change from week 0 to week 12
Urinary nitrogen
Urinary nitrogen excretion measured in 24-hour urine samples collected at baseline and week 12
Measured: Change from week 0 to week 12
Metabolomics, plasma
Non-targeted metabolomics analysis using Liquid Chromatography - Mass Spectrometry
Measured: OGTT: -15, 30, 60, 90, 120 min. Performed at baseline and week 12.
Metabolomics, urine
Non-targeted metabolomics analysis using Liquid Chromatography - Mass Spectrometry
Measured: 24-hour urine collection performed at baseline and week 12.
Metabolomics, faeces
Non-targeted metabolomics analysis using Liquid Chromatography - Mass Spectrometry
Measured: 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
Measured: 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
Measured: 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,
Measured: Faecal samples collected at baseline and week 12.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2016 (estimated)
- Study startMay 2016
- Primary completion29 Jun 2017
- Study completion29 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Abdominal ObesityStudies of the same condition, open and under way.
- More trials run by Aarhus University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aarhus University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Aarhus, Copenhagen University Hospital, Rigshospitalet, University of California, Davis, University of Copenhagen
- Responsible party
- Principal investigator, Søren Gregersen, Aarhus University Hospital
- Investigators
- Søren Gregersen, MD, ph.d., Principal investigator, Aarhus University HospitalKnud Erik B. Knudsen, Professor, Study chair, Department of Animal Science, University of Aarhus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02931630
- Sponsor's protocol ID
- MERITS
- Acronym
- MERITS
- Status last verified
- Jul 2017
- First submitted
- 19 Aug 2016
- Last updated
- 17 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 35422766
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Whey Protein and Dietary Fibers on Risk Markers of the Metabolic Syndrome and Bone Health
- ClinicalTrials.gov ID
- NCT02931630
- Acronym / sponsor ID
- MERITS / MERITS
- Keywords
- Whey protein, Dietary fibers, Wheat bran, Arabinoxylan, Postprandial lipaemia, Body composition, Blood pressure, Metabolic rate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Aarhus University HospitalUniversity, hospital or other
- Collaborators
- University of Aarhus, Copenhagen University Hospital, Rigshospitalet, University of California, Davis, University of Copenhagen
- Study start
- May 2016 (actual)
- Primary completion
- 29 Jun 2017 (actual)
- Study completion
- 29 Jun 2017 (actual)
- First posted
- 13 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| HP/HF | Experimental | Other: Whey protein powder, Other: High fiber breadWhey protein powder / High fiber bread |
| HP/LF | Experimental | Other: Maltodextrin powder, Other: Low fiber breadWhey protein powder / Low fiber bread |
| LP/HF | Experimental | Other: Maltodextrin powder, Other: High fiber breadMaltodextrin powder / High fiber bread |
| LP/LF | Experimental | Other: Whey protein powder, Other: Low fiber breadMaltodextrin powder / Low fiber bread |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Waist circumference ≥ 80 cm (women)/94 cm (men)
- Age ≥40 years
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Whey protein powder60 g of whey protein powder | Other | HP/HF, LP/LF |
| Maltodextrin powder60 g of Maltodextrin powder | Other | HP/LF, LP/HF |
| High fiber breadWheat bread with high content of dietary fibers (approximately 30 g fibers/day) | Other | HP/HF, LP/HF |
| Low fiber breadWheat bread with low content of dietary fibers (approximately 10 g fibers/day) | Other | HP/LF, LP/LF |
Primary outcome
Postprandial triglyceride response
Time frame: Meal test: -15, 0, 60, 90, 120, 240, 360 min. Performed at baseline and at 12 weeks.
Postprandial triglyceride response measured as fasting value and incremental Area Under the Curve (iAUC from -15 - 360 min) following a high-fat meal.
54 secondary outcomes
24 hours blood pressure (BP)
Time frame: Performed at baseline and week 12
24 hours augmentation Index (AI)
Time frame: Performed at baseline and week 12
Respiratory Exchange Ratio
Time frame: Meal test: -30 and 140 min. Performed at baseline and week 12.
Body composition
Time frame: Performed at baseline and week 12
Postprandial apolipoprotein B48 response
Time frame: Meal test: -15, 0, 60, 240, 360 min. Performed at baseline and at 12 weeks.
Glucose response during high-fat meal test
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
Time frame: Meal test: 0, 15, 30, 90, 240 min. Performed at baseline and week 12
Osteoprotegrin response during high-fat meal test
Time frame: Meal test: 0, 15, 30, 90, 240 min. Performed at baseline and week 12
Osteocalcin response during high-fat meal test
Time frame: Meal test: 0, 15, 30, 90, 240 min. Performed at baseline and week 12
25-dihydroxy vitamin D
Time frame: Change from week 0 to week 12
Phosphate
Time frame: Change from week 0 to week 12
Magnesium
Time frame: Change from week 0 to week 12
Total cholesterol
Time frame: Change from week 0 to week 12
Low density lipoprotein (LDL)
Time frame: Change from week 0 to week 12
High density lipoprotein (HDL)
Time frame: Change from week 0 to week 12
Glucose response during oral glucose tolerance test (OGTT)
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)
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)
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)
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)
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)
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)
Time frame: OGTT: 0, 30, 90 min. Performed at baseline and week 12
C-telopeptide (CTX) response during oral glucose tolerance test (OGTT)
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)
Time frame: OGTT: 0, 30, 90 min. Performed at baseline and week 12
Osteoprotegrin response during oral glucose tolerance test (OGTT)
Time frame: OGTT: 0, 30, 90 min. Performed at baseline and week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2017.
- Derived from this study: PubMed 35422766Fuglsang-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Søren Gregersen, MD, ph.d. principal investigator
Aarhus University Hospital
Knud Erik B. Knudsen, Professor study chair
Department of Animal Science, University of Aarhus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Whey protein powder, Maltodextrin powder and High fiber bread in people with Abdominal Obesity and Metabolic Syndrome, run by Aarhus University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postprandial triglyceride response (time frame: Meal test: -15, 0, 60, 90, 120, 240, 360 min. Performed at baseline and at 12 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02931630, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2017.