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Completed

NCT Number: NCT05009615

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

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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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Instituto de Ciencia y Tecnología de Alimentos y Nutrición

Madrid, 28040, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

green coffee extract

Dietary Supplement

150 mg polyphenols from green coffee, twice daily

Beta Glucan

Dietary Supplement

2.5 g BG twice daily

Green coffee + beta-glucan

Dietary Supplement

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

Primary outcomes

  1. Body weight

    Time frame: 8 weeks

    Change of body weight (estimated 2.5 kg) at the end of the intervention

Secondary outcomes

  1. Body fat percentage

    Time frame: 8 weeks

    Change of body fat percentage (total and visceral)

  2. Anthropometry

    Time frame: 8 weeks

    Change of body circumferences (waist, hip, thigh) or skin folds at the end of the intervention

  3. Insulin resistance

    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

  4. Blood lipids

    Time frame: 8 weeks

    Modification of serum levels of total cholesterol, LDL-cholesterol, HDL-cholesterol blood, triglycerides at the end of the intervention

Sponsors and collaborators

Lead sponsor

Instituto de Ciencia y Tecnología de Alimentos y Nutrición

Other Gov

Collaborators

  • Ministerio de Economía y Competitividad, Spain

Registry information

Official study title

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

Acronym: OBHEALTH

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Aug 17, 2021
Registry last updated
Aug 17, 2021

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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