Clinical trial NCT05009615: Efficacy of Hydroxycinnamates and Beta-glucans as a Dietary Tool Against Obesity (OBHEALTH)
Official title: Efficacy of New Products Combining Hydroxycinnamates and Beta-glucans as a Dietary Tool Against Obesity and Associated Dysfunctions (Hyperglycemia and Dyslipemia)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight/Obesity
Insulin Resistance
Keywords: Obesity
Non-communicable diseases
Polyphenols
Soluble dietary fiber
Nutraceutical
Lead sponsor: Instituto de Ciencia y Tecnología de Alimentos y Nutrición
Sponsor class: OTHER_GOV
Collaborators: name: Ministerio de Economía y Competitividad, Spain
First posted: 2021-08-17
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: After a run-in period, participants were randomly allocated to one of each arm. Each intervention stage (8 weeks) was separated by a 4-week wash-out.
Primary purpose: BASIC_SCIENCE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Men and women, with BMI between 25-35 kg/m2
* Fasting blood glucose between 6,11-6,94 mmol/L (110-125 mg/dL) and/or
* Blood glucose between 7,77-11,04 mmol/L (140-199 mg/dL) 2 h after an oral glucose overload

Exclusion Criteria:

* Having other chronic pathologies different from overweight/obesity and prediabetes.
* On prescription drugs, hormones or dietary supplements (e.g. dietary fibre, pollen, vitamin complexes, etc.)
* Vegetarian
* Smoking
* Known hypersensibility/allergy to any of the tests products
* Pregnant women
* On dietary regimen or physical training to lose weight

Primary outcomes:
measure: Body weight
timeFrame: 8 weeks
Secondary outcomes:
measure: Body fat percentage
timeFrame: 8 weeks
measure: Anthropometry
timeFrame: 8 weeks
measure: Insulin resistance
timeFrame: 8 weeks
measure: Blood lipids
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Instituto de Ciencia y Tecnología de Alimentos y Nutrición
Study officials:
affiliation: ICTAN-CSIC
name: Laura Bravo, Prof
role: PRINCIPAL_INVESTIGATOR
References: