CompletedNot Applicable

Oat and Cholesterol

Canada207 participantsStarted 2019-04-10

Plain-language summary

The primary objective is to assess the effect of an oat ingredient provided over 4 weeks on serum LDL cholesterol in men and women with elevated LDL-cholesterol compared to a placebo. Secondary endpoints are fasting serum total- and HDL-cholesterol, non-HDL-cholesterol, triglycerides, glucose, insulin, glycated albumin, HOMA-IR and Framingham risk score

Who can participate

Age range18 Years – 65 Years

SexALL

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Inclusion criteria

✓. Fasting LDL cholesterol 116-193 mg/dl (3-5 mmol/L)
✓. Males and non-pregnant, non-lactating females 18-65 years
✓. Agree to consume the investigational product three times daily for the duration of the study
✓. BMI 18.5 to 39.9 kg/m2
✓. Blood pressure \<160/100 mmHg
✓. Fasting triglycerides \<4.0 mmol/L
✓. Fasting serum glucose \<126mg/dL (\<7 mmol/L)
✓. Serum urea and creatinine \< 1.8 times upper limit of normal (ULN)

Exclusion criteria

✕. Pregnancy, breastfeeding or planning to be pregnant
✕. Allergy or sensitivity to study product ingredients
✕. Dislike description of study product
✕. Diet containing ≥15% of energy from saturated fat
✕. Consuming \>20g fiber/per 1000 Kcal or \>40g fiber/day (including soluble fiber supplements)
✕. Consumption of more than 2 drinks of alcohol per day, or more than 14 drinks per week

What they're measuring

Change in fasting serum LDL-cholesterol

Timeframe: Baseline vs. Week 4

Trial details

NCT IDNCT03911427

SponsorPepsiCo Global R&D

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2020-02-20

View on ClinicalTrials.gov More Elevated LDL Cholesterol trials