Instituto de Ciencia y Tecnología de Alimentos y Nutrición
Madrid, 28040, Spain
NCT Number: NCT05009615
The study aimed at assessing the effect of a decaffeinated green coffee extract, rich in hydroxycinnamates, oat beta-glucans or the combination of both bioactive compounds on overweight/obese subjects with hyperglycemia.
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Notify Me18 year–60 year
All sexes
Interventional
Not applicable
Madrid, 28040, Spain
In a randomized, crossover, blind, three-arm study, volunteers consumed twice a day a nutraceutical providing 5 g/d beta-glucan (BG), 600 mg/d green coffee polyphenols (GC) or a combination of both (5 g/d BG + 600 mg/d GC). Each intervention stage lasted 8 weeks and was followed by a 4-week wash-out.
Blood, urine and fecal samples were obtained at the beginning and end of each intervention stage. Blood pressure, oral glucose tolerance test (OGTT) and body composition (body weight, anthropometry, bioimpedance) were measured at each control visit. Physical activity was controlled by accelerometry (1 week during each intervention stage). Energy expenditure was measured by calorimetry. Food intake was monitored by 3-d food records. Satiety was determined by subjective (VAS) and objective (weighting consumed food) records after consuming the nutraceutical during each intervention stage.
In a subset of volunteers (9), a pharmacokinetic study was performed to assess bioavailability and metabolism of polyphenols at the beginning and end of each intervention (GC and GC+BG only). In these volunteers, blood was taken at different times during 24 h; urine samples were also collected at different intervals during 24 h, and feces were obtained at 0 and 24 h approximately after consuming the nutraceuticals containing GC. A targeted metabolomic analysis was carried out in these samples. In these volunteers, incretins and hormones were also determined in blood samples.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
150 mg polyphenols from green coffee, twice daily
2.5 g BG twice daily
150 mg polyphenols from green coffee + 2.5 g BG, twice daily
Time frame: 8 weeks
Change of body weight (estimated 2.5 kg) at the end of the intervention
Time frame: 8 weeks
Change of body fat percentage (total and visceral)
Time frame: 8 weeks
Change of body circumferences (waist, hip, thigh) or skin folds at the end of the intervention
Time frame: 8 weeks
Change in fasting blood glucose and/or insulin levels, use to calculate homeostasis model assessment (HOMA) of insulin resistance (HOMA-IR), beta-cell function (HOMA-beta) or quantitative insulin sensitivity check index (QUICKI) indexes. Outcome would be a modification of at least one of these indexes at the end of the intervention
Time frame: 8 weeks
Modification of serum levels of total cholesterol, LDL-cholesterol, HDL-cholesterol blood, triglycerides at the end of the intervention
Instituto de Ciencia y Tecnología de Alimentos y Nutrición
Other Gov
Efficacy of New Products Combining Hydroxycinnamates and Beta-glucans as a Dietary Tool Against Obesity and Associated Dysfunctions (Hyperglycemia and Dyslipemia)
Acronym: OBHEALTH
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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