Tests milk with and without lactose in adults with prediabetes and lactose intolerance

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with pre-diabetes who carry the lactase non-persistence gene type (LCT rs4988235, GG) and drink little milk. It compares lactose-containing and lactose-free milk.

Age

18 to 70 years

Sex

All sexes can join.

Disease stage

History of pre-diabetes: fasting blood glucose 100-125 mg/dL (5.6–6.9 mmol/L) and/or HbA1c 5.7-6.4% (39–46 mmol/mol), with no diabetes diagnosis and no diabetes medication.

Earlier treatment

Cannot have taken antibiotics in the last 3 months. People taking probiotics, fiber supplements, laxatives, stool softeners, anti-diarrheal drugs or lactase pills must be able to stop them during the study.

Biomarker or test result

LCT gene rs4988235, GG genotype (lactase non-persistence).

Main reasons for not taking part

• Diabetes diagnosis or taking anti-diabetes medication
• Cancer, cardiovascular disease or a life-threatening illness
• Known milk allergy or severe stomach and bowel symptoms after drinking milk
• Pregnant or breastfeeding
• Smoking or more than 1 alcoholic drink a day

The registry criteria, word for word

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

• Are you between 18 and 70 years old?YesNo

What the trial wants to find out

Individuals with lactase non-persistence (LNP; determined by a functional variant in the LCT gene [rs4988235, GG genotype]) are susceptible to lactose intolerance in adulthood due to deficiency of lactase, the enzyme which digests milk lactose sugars. However, many LNP individuals still drink ≥1 cup of milk daily. Recent analysis in the Hispanic Community Health Study/Study of Latinos (HCHS/SOL) found that consumption of 1 serving (cup) of milk/day was associated with ~30% lower risk of type 2 diabetes among LNP individuals, but not among individuals with lactase persistence (LP). This beneficial effect might be partially explained by favorable alterations in gut microbiota and related metabolites associated with higher milk consumption among LNP individuals. Based on these observational study findings, the investigator team proposes to conduct a randomized, controlled trial of lactose-containing vs. lactose-free milk in LNP individuals with pre-diabetes, to comprehensively investigate the effects of milk intake on the gut microbiome and glycemic outcomes.

The 2 groups in the trial

• Lactose-Containing MilkExisting treatment, for comparison

  Participants will be randomized to lactose-containing milk in strata of age (\<60, ≥60) and sex (female, male). Within each age and sex stratum, 10 participants will be randomized into two intervention groups in a 1:1 ratio

• Lactose-Free MilkExisting treatment, for comparison

  Participants will be randomized to lactose-free milk in strata of age (\<60, ≥60) and sex (female, male). Within each age and sex stratum, 10 participants will be randomized into two intervention groups in a 1:1 ratio