Obesity
Conditions
Keywords
obesity, supplements, body mass index, overweight
Brief summary
This randomized, double-blind, placebo-controlled trial assessed the impact of a dietary fiber supplement (glucomannan, inulin, and psyllium) on weight and metabolic parameters in individuals with obesity-related genetic polymorphisms (FTO, MC4R, LEP, LEPR). Participants were adults aged 18-65 with a BMI ≥ 25 and confirmed genetic predispositions. The study, involving 216 participants (108 per group), ran over 12 weeks with assessments at 0, 4, 8, and 12 weeks. Primary outcome was Body-weight change in %. The study aimed to clarify the role of fiber supplements in genetically predisposed obese individuals.
Interventions
DIETARY_SUPPLEMENTglucomannan, inulin, and psyllium
the subjects recieved fiber supplement containing glucomannan, inulin, and psyllium
OTHERplacebo
the subjects recieved placebo
Sponsors
Center of New Medical Technologies
Triangel Scientific
S.LAB (SOLOWAYS)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Confirmed presence of one or more specified gene polymorphisms (FTO, MC4R, LEP, LEPR). * Overweight or obese status (BMI ≥ 25).
Exclusion criteria
\- BMI \< 25
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Body-weight change in % | 180 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| body-weight reduc-tion ≥10% | 180 days | — |
| Body weight in kg | 180 days | — |
| Body mass index change in % | 180 days | — |
| Fat mass change in % | 180 days | — |
| Systolic blood pressure in mmHg | 180 days | — |
| Fat-free mass change in kg | 180 days | — |
| Visceral fat rating change from baseline | 180 days | — |
| body-weight reduction ≥5% | 180 days | — |
| Total cholesterol ratio | 180 days | — |
| LDL-C ratio | 180 days | — |
| HDL-C ratio | 180 days | — |
| Triglycerides ratio | 180 days | — |
| hsCRP ratio | 180 days | — |
| Fasting plasma glucose mmol/l | 180 days | — |
| Side effects % | 180 days | any side effects or adverse events reported by subjects |
| Diastolic blood pressure in mmHg | 180 days | — |
Countries
Russia
Outcome results
None listed