An interventional study of full-fat milk in Lactose Malabsorption and Cardiovascular Disease, sponsored by Huazhong University of Science and Technology. Status unknown at 1 site in China. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-06-27.
Sponsored by Huazhong University of Science and Technology · Not applicable, Interventional, and Prevention
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.
53 studies on the registry are indexed under Lactose Intolerance; 6 are open to participants now.
This study's planned enrollment of 60 is above the median of 41 across 41 interventional studies indexed under Lactose Intolerance.
Browse Lactose Intolerance studies →Huazhong University of Science and Technology is the lead sponsor of 247 studies on the registry; 62 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
Dietary Supplement: full-fat milk
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.
Dietary Supplement: full-fat milk
intake 250ml full-fat milk per day, do not intake any other dairy products
Changes in body weight
Time frame: 4 weeks
Change in body composition (body fat mass and lean mass)
Body fat mass and lean mass measured by Bioelectric Impedance Analysis(BIA)
Time frame: 4 weeks
Changes in blood pressure
Systolic Blood Pressure and Diastolic Blood Pressure before and after milk intervention
Time frame: 4 weeks
Changes in blood lipids profile
Fasting plasma Total cholesterol, Low Density Lipoprotein, High Density Lipoprotein and triglycerides before and after milk intervention
Time frame: 4 weeks
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)
Insulin sensitivity measure derived from fasting glucose and insulin
Time frame: 4 weeks
Changes in pro-inflammatory markers
Fasting plasma C-reactive protein, interleukin-6 and tumor necrosis factor-α before and after milk intervention
Time frame: 4 weeks
Changes in markers of oxidative stress
Fasting plasma MDA, oxidized LDL before and after milk intervention
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)
Fecal acetate, propionate, butyrate before and after milk intervention
Time frame: 4 weeks
The record gives a start of May 2016 and a primary completion of Aug 2016. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Jun 2016. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Huazhong University of Science and Technology →