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Efficacy of Hydroxycinnamates and Beta-glucans as a Dietary Tool Against Obesity (OBHEALTH)

Efficacy of New Products Combining Hydroxycinnamates and Beta-glucans as a Dietary Tool Against Obesity and Associated Dysfunctions (Hyperglycemia and Dyslipemia)

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05009615
Acronym
OBHEALTH
Enrollment
30
Registered
2021-08-17
Start date
2018-12-03
Completion date
2019-12-14
Last updated
2021-08-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Insulin Resistance, Overweight/Obesity

Keywords

Obesity, Non-communicable diseases, Polyphenols, Soluble dietary fiber, Nutraceutical

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.

Interventions

DIETARY_SUPPLEMENTGreen coffee extract

150 mg polyphenols from green coffee, twice daily

DIETARY_SUPPLEMENTBeta glucan

2.5 g BG twice daily

DIETARY_SUPPLEMENTGreen coffee + beta-glucan

150 mg polyphenols from green coffee + 2.5 g BG, twice daily

Sponsors

Ministerio de Economía y Competitividad, Spain
CollaboratorOTHER_GOV
Instituto de Ciencia y Tecnología de Alimentos y Nutrición
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)

Masking description

Nutraceutical was provided in aluminum foil sachets marked A, B or C for blinding to participants. Aroma and flavor compounds were added to ensure similar organoleptic properties of the 3 nutraceuticals tested.

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Body weight8 weeksChange of body weight (estimated 2.5 kg) at the end of the intervention

Secondary

MeasureTime frameDescription
Body fat percentage8 weeksChange of body fat percentage (total and visceral)
Anthropometry8 weeksChange of body circumferences (waist, hip, thigh) or skin folds at the end of the intervention
Insulin resistance8 weeksChange 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
Blood lipids8 weeksModification of serum levels of total cholesterol, LDL-cholesterol, HDL-cholesterol blood, triglycerides at the end of the intervention

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026