Actively Recruiting
Assessment of the Potential Antidiabetic Effects of Olive Pomace Oil in Diabetic or Prediabetic Subjects: Postprandial Study and Chronic Intervention
Led by Instituto de Ciencia y Tecnología de Alimentos y Nutrición · Updated on 2024-12-11
50
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
Sponsors
I
Instituto de Ciencia y Tecnología de Alimentos y Nutrición
Lead Sponsor
I
ICTAN-CSIC - Madrid - Spain
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating whether olive pomace oil can benefit people with type 2 diabetes or those at risk of developing it, such as prediabetic individuals. The study aims to determine if olive pomace oil can prevent high blood sugar spikes after meals, lower fasting blood glucose levels when consumed daily, and improve glucose regulation along with other issues like high blood fats and inflammation. The effects of olive pomace oil will be compared to a high-oleic acid sunflower oil to assess their impact on these health measures. The study includes two parallel parts: a postprandial study and a chronic intervention. In the postprandial study, participants will visit the Human Nutrition Unit on different days to consume white bread alone or with different oils (extra virgin olive oil, olive pomace oil, or high-oleic acid sunflower oil) while blood samples are taken to measure blood sugar and hormone responses. The chronic study is a randomized, double-blind crossover trial lasting 22 weeks, where participants consume corn oil for 3 weeks, then either olive pomace oil or sunflower oil for 8 weeks each, with a 3-week washout period of corn oil between. Participants must avoid other oils and high-fat foods during the study. Participants will visit the clinic every 4 weeks during the chronic study for health checkups including blood pressure, body weight, and blood tests. They will keep diaries of their insulin or metformin use and blood glucose measurements at home. Diet and physical activity will be monitored through questionnaires, phone interviews, and wearing an accelerometer for a week. Researchers will assess fasting and post-meal blood glucose, insulin resistance, lipid levels, inflammation markers, and other hormones to understand how olive pomace oil affects diabetes-related health measures.
CONDITIONS
Brief Title
Antidiabetic Effect of Olive Pomace Oil
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Fasting blood glucose between 100-126 mg/dL and/or
- Glycated haemoglobin (HbA1c) between 5.7-6.4% and/or
- Diagnosed with diabetes and fasting blood glucose greater than 126 mg/dL and/or
- Diagnosed with diabetes and glycated haemoglobin (HbA1c) greater than 6.4%
- Age between 20 and 70 years
You will not qualify if you...
- Kidney or liver diseases
- Gastrointestinal diseases such as irritable bowel syndrome, Crohn disease, or chronic bowel inflammation
- Food allergies or intolerances
- Vegetarian or vegan diet
- Smoking
- Pregnant or lactating women
- Taking prescription drugs other than for hypertension, thyroid, dyslipidemia, or glucose control, or having dosage changes in the last 3 months
- Consumption of vitamins, dietary supplements, or nutraceuticals
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 3 weeks
Participants consume corn oil as the only dietary oil during this 3-week period before starting the intervention.
Visits during weeks 1 and 2 to perform postprandial tests with white bread alone or with extra virgin olive oil
Duration - 3 weeks overlapping with run-in and start of intervention
Participants attend visits to consume white bread alone or with different oils to measure postprandial glycemic and insulinemic responses, including blood sample collections.
Multiple visits on different days during weeks 1, 2, and start of intervention
Duration - 8 weeks per intervention arm
Participants consume either olive pomace oil or high-oleic acid sunflower oil as the only dietary fat for 8 weeks per intervention arm in a randomized crossover design. They maintain habitual diet and physical activity with monitoring.
3 visits per intervention arm (beginning, middle, and end)
Duration - 3 weeks
Participants consume corn oil as the only dietary oil for 3 weeks between intervention arms to clear previous treatment effects.
No scheduled visits reported
Trial Site Locations
Total: 1 location
1
Institute of Food Science, Technology and Nutrition (ICTAN-CSIC)
Madrid, Madrid, Spain, 28040
Actively Recruiting
Research Team
L
Laura Bravo, Professor
B
Beatriz Sarria, Dr
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
BASIC_SCIENCE
Number of Arms
2
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