Lactose MalabsorptionNCT02798718
Whole Milk Intake and Cardio-metabolic Risk Factors
A study testing full-fat milk in people with Lactose Malabsorption and Cardiovascular Disease, run by Huazhong University of Science and Technology at 1 site in China.
Trial summary
Milk is the source of high-quality protein, calcium, and other vitamins and minerals. Epidemiologic studies have linked high consumption of milk with risk of metabolic syndrome, T2DM, hypertension and obesity, which are independent risk factors of cardiovascular disease. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Lactose Malabsorption, Cardiovascular Disease
- What is being tested?
- full-fat milk
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- May 2016to Aug 2016
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged above 18 years of age
- Able to give informed connect
Who cannot join
- Unwilling to trial dietary intervention
- Pregnancy
- Known cardiovascular disease (stroke, ischemic heart disease and so on), diabetes, hypertension and any other chronic disease.
- Known gastrointestinal disease, such as Irritable Bowel Syndrome(IBS), functional bowel disease and so on.
- Evidence of drug or alcohol abuse
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Huazhong University of Science and Technology
Wuhan, Hubei, 430030
Liegang Liu, PhD, +86-27-83650522, liegangliu@gmail.com
Xiaoqin Li, PhD
About this study
Official title: Effect of Whole Milk Intake on the Cardio-metabolic Risk Factors of Healthy Person With or Without Lactose Maldigestion
Milk is the source of high-quality protein, calcium, and other vitamins and minerals. Epidemiologic studies have linked high consumption of milk with risk of metabolic syndrome, T2DM, hypertension and obesity, which are independent risk factors of cardiovascular disease. However, milk contains disaccharide lactose, which may cause gastrointestinal problems in those adults with poor digestion. Recent studies have shown that subjects with intolerance to lactose tend to reduce their consumption of milk. Actually, consumption of 12g lactose (240ml milk) per day produces negligible symptoms in lactose intolerant. Furthermore, a dairy-rich diet could improve lactose intolerance because of colonic adaption to it. Lactose maldigestion would not be a restricting factor in milk intake. In general, the undigested lactose will be fermented by colonic bacteria into hydrogen, carbon dioxide, and short-chain fatty acids (SCFA: acetate, propionate, and butyrate). The SCFAs may have beneficial effects on human glucose and lipid metabolism, and the lactose fermentation may change the intestinal flora profile. But there are few studies evaluating effect of milk intake on health of people with lactose malabsorption or intolerance.This trial intend to study the effect of whole milk on cardio-metabolic risk factors of healthy person with or without lactose maldigestion.
- Conditions
- Lactose Malabsorption, Cardiovascular Disease
- Being tested
- full-fat milk
- Medical subject headings
- Lactose Intolerance, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
full-fat milkDietary supplement
intake 250ml full-fat milk per day, do not intake any other dairy products
| Study group | Role | What they receive |
|---|---|---|
| lactose digesters | Active comparator | Participants in arm 1 are grouped as lactose digesters based on breath hydrogen test after a 25-g lactose load. The breath hydrogen excretion is less than 20 ppm. Receives: Dietary Supplement: full-fat milk |
| lactose maldigesters | Active comparator | Participants in arm 2 are also grouped as lactose maldigesters based on breath hydrogen test after a 25-g lactose load. The breath hydrogen excretion is not less than 20 ppm. Receives: Dietary Supplement: full-fat milk |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in body weight
Measured: 4 weeks
Change in body composition (body fat mass and lean mass)
Body fat mass and lean mass measured by Bioelectric Impedance Analysis(BIA)
Measured: 4 weeks
Changes in blood pressure
Systolic Blood Pressure and Diastolic Blood Pressure before and after milk intervention
Measured: 4 weeks
Changes in blood lipids profile
Fasting plasma Total cholesterol, Low Density Lipoprotein, High Density Lipoprotein and triglycerides before and after milk intervention
Measured: 4 weeks
Changes in fasting plasma glucose
Measured: 4 weeks
Changes in fasting plasma insulin
Measured: 4 weeks
Changes in fasting plasma C-peptide
Measured: 4 weeks
Changes in Homeostasis Model Assessment of Insulin Resistance(HOMA-IR)
Insulin sensitivity measure derived from fasting glucose and insulin
Measured: 4 weeks
Secondary outcomes (5)
Changes in pro-inflammatory markers
Fasting plasma C-reactive protein, interleukin-6 and tumor necrosis factor-α before and after milk intervention
Measured: 4 weeks
Changes in markers of oxidative stress
Fasting plasma MDA, oxidized LDL before and after milk intervention
Measured: 4 weeks
Biomarkers in urine
Measured: 4 weeks
Changes in fecal fat excretion
Measured: 4 weeks
Changes in fecal short chain fatty acids (SCFA)
Fecal acetate, propionate, butyrate before and after milk intervention
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2016 (estimated)
- Study startMay 2016
- Primary completionAug 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lactose MalabsorptionStudies of the same condition, open and under way.
- More trials run by Huazhong University of Science and TechnologyThe 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
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huazhong University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Liegang Liu, Huazhong University of Science and Technology
- Investigators
- Liegang Liu, PhD, Study chair, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02798718
- Sponsor's protocol ID
- 0214513214
- Status last verified
- Jun 2016
- First submitted
- 24 May 2016
- Last updated
- 27 Jun 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Whole Milk Intake on the Cardio-metabolic Risk Factors of Healthy Person With or Without Lactose Maldigestion
- ClinicalTrials.gov ID
- NCT02798718
- Acronym / sponsor ID
- 0214513214
- Conditions
- Lactose Malabsorption, Cardiovascular Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- Aug 2016 (estimated)
- First posted
- 14 Jun 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.
Milk is the source of high-quality protein, calcium, and other vitamins and minerals. Epidemiologic studies have linked high consumption of milk with risk of metabolic syndrome, T2DM, hypertension and obesity, which are independent risk factors of cardiovascular disease. However, milk contains disaccharide lactose, which may cause gastrointestinal problems in those adults with poor digestion. Recent studies have shown that subjects with intolerance to lactose tend to reduce their consumption of milk. Actually, consumption of 12g lactose (240ml milk) per day produces negligible symptoms in lactose intolerant. Furthermore, a dairy-rich diet could improve lactose intolerance because of colonic adaption to it. Lactose maldigestion would not be a restricting factor in milk intake. In general, the undigested lactose will be fermented by colonic bacteria into hydrogen, carbon dioxide, and short-chain fatty acids (SCFA: acetate, propionate, and butyrate). The SCFAs may have beneficial effects on human glucose and lipid metabolism, and the lactose fermentation may change the intestinal flora profile. But there are few studies evaluating effect of milk intake on health of people with lactose malabsorption or intolerance.This trial intend to study the effect of whole milk on cardio-metabolic risk factors of healthy person with or without lactose maldigestion.
Study design
- Primary purpose
- Prevention
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| lactose digesters | Active comparator | Dietary Supplement: full-fat milkParticipants in arm 1 are grouped as lactose digesters based on breath hydrogen test after a 25-g lactose load. The breath hydrogen excretion is less than 20 ppm. |
| lactose maldigesters | Active comparator | Dietary Supplement: full-fat milkParticipants in arm 2 are also grouped as lactose maldigesters based on breath hydrogen test after a 25-g lactose load. The breath hydrogen excretion is not less than 20 ppm. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Aged above 18 years of age
- Able to give informed connect
Key exclusion criteria (5 listed)
- Unwilling to trial dietary intervention
- Pregnancy
- Known cardiovascular disease (stroke, ischemic heart disease and so on), diabetes, hypertension and any other chronic disease.
- Known gastrointestinal disease, such as Irritable Bowel Syndrome(IBS), functional bowel disease and so on.
- Evidence of drug or alcohol abuse
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 |
|---|---|---|
| full-fat milkintake 250ml full-fat milk per day, do not intake any other dairy products | Dietary supplement | lactose digesters, lactose maldigesters |
Primary outcome
Changes in body weight
Time frame: 4 weeks
Change in body composition (body fat mass and lean mass)
Time frame: 4 weeks
Body fat mass and lean mass measured by Bioelectric Impedance Analysis(BIA)
Changes in blood pressure
Time frame: 4 weeks
Systolic Blood Pressure and Diastolic Blood Pressure before and after milk intervention
Changes in blood lipids profile
Time frame: 4 weeks
Fasting plasma Total cholesterol, Low Density Lipoprotein, High Density Lipoprotein and triglycerides before and after milk intervention
Changes in fasting plasma glucose
Time frame: 4 weeks
Changes in fasting plasma insulin
Time frame: 4 weeks
Changes in fasting plasma C-peptide
Time frame: 4 weeks
Changes in Homeostasis Model Assessment of Insulin Resistance(HOMA-IR)
Time frame: 4 weeks
Insulin sensitivity measure derived from fasting glucose and insulin
5 secondary outcomes
Changes in pro-inflammatory markers
Time frame: 4 weeks
Changes in markers of oxidative stress
Time frame: 4 weeks
Biomarkers in urine
Time frame: 4 weeks
Changes in fecal fat excretion
Time frame: 4 weeks
Changes in fecal short chain fatty acids (SCFA)
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2016.
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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.
Liegang Liu, PhD study chair
Huazhong University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing full-fat milk in people with Lactose Malabsorption and Cardiovascular Disease, run by Huazhong University of Science and Technology at 1 site in China.
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 5 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: status not confirmed, as of the sponsor's last update on 27 Jun 2016. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Liegang Liu, PhD (+86-27-83650522, liegangliu@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in body weight (time frame: 4 weeks). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Jun 2016.