Calcium fructoborate effect on systemic inflammation and dyslipidaemia markers in middle-aged people with primary osteoarthritis

A double-blind, placebo-controlled pilot study to evaluate FruitexB® (calcium fructoborate) effect on systemic inflammation and dyslipidaemia markers in middle-aged people with primary osteoarthritis

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN46679573

Enrollment

Registered

2010-03-17

Start date

2008-03-10

Completion date

Unknown

Last updated

2021-01-11

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

Conditions

Primary osteoarthritis Musculoskeletal Diseases Polyarthrosis

Interventions

The study was double-blind and placebo-controlled. For ease of presentation the four subject groups are given the following descriptors: Group 1: 30 mg FruitexB® twice per day

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Men and non-pregnant women 2. Aged 40 - 85 years 3. Primary OA of at least one knee as demonstrated by a radiological examination carried out within the previous 3 months 4. Body mass index (BMI) less than 28 and greater than 24.4 kg/m^2 5. Elevated blood levels of at least one inflammatory marker

Exclusion criteria

Exclusion criteria: 1. Individuals with digestion problems 2. Subjects with a fever and/or under treatment with antibiotics 3. Subjects with fructose intolerance 4. Subjects taking any painkillers and/or vitamin B6 5. Subjects taking aspirin 6. Current use of non-steroidal anti-inflammatory drugs (NSAIDS) and acetominophen

Design outcomes

Primary

Measure	Time frame
Determination of biochemical parameters. Blood samples for biochemical analyses were taken from fasting venous blood in the morning at the start, and after 2 weeks of treatment. Commercial tubes without anticoagulant were used to collect blood for determination of biochemical parameters. Basic biochemical parameters, lipid profile (total cholesterol, high density lipoprotein [HDL-], low density lipoprotein [LDL-] cholesterol, and inflammatory markers (C-reactive protein [CRP], erythrocyte sedimentation rate [ERS] and fibrinogen) were analysed in serum by standard biochemical procedures using the Hitachi 911 automatic analyser and kits (Roche, Switzerland). Due to known correlations between selected markers, the following ratios were used for processing the data: CHOL/CRP and HDL/CRP.	—

Measure

Time frame

Determination of biochemical parameters. Blood samples for biochemical analyses were taken from fasting venous blood in the morning at the start, and after 2 weeks of treatment. Commercial tubes without anticoagulant were used to collect blood for determination of biochemical parameters. Basic biochemical parameters, lipid profile (total cholesterol, high density lipoprotein [HDL-], low density lipoprotein [LDL-] cholesterol, and inflammatory markers (C-reactive protein [CRP], erythrocyte sedimentation rate [ERS] and fibrinogen) were analysed in serum by standard biochemical procedures using the Hitachi 911 automatic analyser and kits (Roche, Switzerland). Due to known correlations between selected markers, the following ratios were used for processing the data: CHOL/CRP and HDL/CRP.

—

Secondary

Measure	Time frame
In neurological literature on diabetic peripheral neuropathy, several neuropathic symptoms and signs scales have been developed, such as the Neurological Symptom Score, the extensive Neuropathy Symptom Profile, and the Neurological Disability Score [B]. These physician-based scales are used primarily in diabetic neuropathy trials in order to diagnose the absence or presence of peripheral neuropathy, although the Neurological Symptom Score does not emphasise actual severity of complaints. Furthermore, consensus guidelines have been published on quantitative sensory testing [B], and on standardised measures in diabetic neuropathy [B]. We used said guidelines to determine paresthesias numbness. These were measured at the first visit in the day when study begun, and the next measure was done after 2 weeks.	—

Measure

Time frame

In neurological literature on diabetic peripheral neuropathy, several neuropathic symptoms and signs scales have been developed, such as the Neurological Symptom Score, the extensive Neuropathy Symptom Profile, and the Neurological Disability Score [B]. These physician-based scales are used primarily in diabetic neuropathy trials in order to diagnose the absence or presence of peripheral neuropathy, although the Neurological Symptom Score does not emphasise actual severity of complaints. Furthermore, consensus guidelines have been published on quantitative sensory testing [B], and on standardised measures in diabetic neuropathy [B]. We used said guidelines to determine paresthesias numbness. These were measured at the first visit in the day when study begun, and the next measure was done after 2 weeks.

—

Countries

Romania

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026