Type 2 Diabetics randomized to isoleucine group

Type 2 Diabetics randomized to placebo group

gender-, age-, BMI-matched controls for baseline measurements only. No supplementation provided.

Type 2 Diabetes

Supplement provided in capsules. Half the capsules to be taken with lunch and the other half with dinner. All supplements are commercially available.

Oral Supplement

Placebo

Texas A&M University CTRAL

Isoleucine Intake and Intermediary Metabolism in Type 2 Diabetes

Change in whole-body protein synthesis rate after 10 days of isoleucine supplementation

Blood glucose levels measured by continuous glucose monitor for 10 days of isoleucine supplementation

Whole-body production rate of glycerol in postabsorptive state

Whole-body production rate of glucose in postabsorptive state

Measured by a validated questionnaire on a fourteen item self-assessment scale. Seven of the items related to anxiety and seven relate to depression. Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 (no symptoms) and 21 (severe symptoms) for either anxiety or depression.

A psychological distress scale to measure mood disturbance in 6 domains - fatigue-inertia, vigor-activity, tension-anxiety, depression-dejection, anger-hostility, and confusion-bewilderment. Healthy populations take 3 to 7 minutes to complete, and others may take up a bit longer.

In Part A, the examinee is instructed to connect a set of 25 circles with numbers as quickly as possible while maintaining accuracy. In Part B, the examinee is instructed to connect a set of 25 circles, alternating between numbers and letters, as quickly as possible while maintaining accuracy. Measures attentional resources and is a measure of the frontal lobe "executive" functions of visual search, set-switching and mental flexibility. The total time in seconds was reported for each measure.

MoCa assesses several cognitive domains and is used for the screening of mild cognitive impairment. Total scores range from 0-30 with lower scores indicating decreased functioning.

Brief-A is a standardized self-report that captures views of an adult's executive functions or self-regulation in his or her everyday environment.

Self administered questionnaire that measures each of the following eight health concepts: Physical Functioning (PF); Role-Physical (RP); Bodily Pain (BP); General Health (GH); Vitality (VT); Social Functioning (SF); Role-Emotional (RE); Mental Health (MH) as well as a reported Health Transition item (HT)

Skeletal muscle strength measured by handgrip and Kin-Com 1-leg test

Functional exercise capacity assessed by 6-minute walk test

Participants attempt to match a position-time sinusoidal target with their right arm while reacting with their left arm.

Participants attempt to coordinate both the right and left arm to match a visual pattern.

Description to be provided: Data may be shared upon request for up to 6 years beyond completion of the trial based on methods/proposal approved by both parties' institutional review committees. Individual participant data that underlie the results of the trial may be shared after de-identification (text, tables, figures, and appendices). Additional documents available per request include: study protocol, statistical analysis plan, and informed consent. Requests should be directed to Dr. Marielle Engelen (mpkj.engelen@ctral.org).

Marielle PKJ Engelen, PhD

Associate Professor

Texas A&M University

After an 8-10 hour overnight fast, Group A will receive two soft capsules of TPGS (400mg) emulsified berberine. Following a 7 day wash out period, Group A participants will then receive four capsules of the Quillaja extract emulsified berberine (200mg). Following another 7 day wash out period, Group A participants will then receive two hard shell capsules of the berberine reference powder 400mg. Each TPGS and berberine reference powder capsules contains 400 mg berberine. Each Quillaja extract capsule contains 200 mg berberine. The total amount of berberine throughout is 800 mg.

After an 8-10 hour overnight fast, Group B will receive four soft capsules of Quillaja extract emulsified berberine (400mg). Following a 7 day wash out period, Group B participants will then receive two hard shell capsules of the berberine reference powder (400mg). Following another 7 day wash out period, Group B participants will then receive two soft gel capsules of TPGS emulsified berberine (400mg). Each TPGS and berberine reference powder capsules contains 400 mg berberine. Each Quillaja extract capsule contains 200mg berberine. The total amount of berberine throughout is 800 mg.

After an 8-10 hour overnight fast, Group C will receive two hard shell capsules of the berberine reference powder (400mg). Following a 7 day wash out period, Group C participants will then receive two soft gel capsules of TPGS emulsified berberine (400mg). Following another 7 day wash out period, Group C participants will then receive four capsules of the Quillaja extract emulsified berberine (200mg). Each TPGS and berberine reference powder capsules contains 400 mg berberine. Each Quillaja extract capsule contains 200mg berberine. The total amount of berberine throughout is 800 mg.

Healthy

Two capsules of berberine. Each capsule contains 400 mg berberine. The total amount of berberine throughout is 800 mg.

Berberine

Two capsules of TPGS/Quillaja extract emulsified berberine. Each capsule contains 400 mg berberine. The total amount of berberine throughout is 800 mg.

TPGS emulsified berberine

Four capsules of Quillaja extract emulsified berberine. Each capsule contains 200 mg berberine. The total amount of berberine throughout is 800 mg.

Quillaja extract emulsified berberine

Food Science and human nutrition department at University of Florida

The Absorption of Bioactive Berberine in Human

To Test the Efficacy of Novel Berberine Emulsification by TPGS or Quillaja Extract on the Absorption of Berberine Compared to Berberine Powder in Humans

To determine change in bioavailability of orally ingested berberine in human volunteers by increasing the area under the concentration-time curve (AUC).

To determine change in bioavailability of orally ingested berberine in human volunteers by increasing its plasma concentration peak concentration (Cmax).

To determine change in bioavailability of orally ingested berberine in human volunteers by increasing its the time point of maximum plasma concentration (Tmax).

To determine change in berberine metabolites concentrations.

University of Florida

Florida High Tech Corridor Council

Designs for Health, Inc.

HTS stimulation while walking at a comfortable pace for 30 minutes.

Sensory TENS while walking at a comfortable pace for 30 minutes.

HTS stimulation while walking at a comfortable pace for 30 minutes.
Hybrid Training System (HTS): Electrodes will be placed over the quadriceps and hamstrings. Electrical stimulation parameters will be based on a standard Russian waveform in which a 5000 Hz carrier frequency is modulated at 40 Hz (2.4 ms on, 22.6 ms off) to deliver a rectangular voltage biphasic pulse. Acceleration sensors as a joint motion sensor is placed on the front of each leg 88mm above the patellar edge. It analyzes the algorithm of each exercise pattern, and stimulates the antagonist of the motion of each bilateral knee joint during exercise. Electrical stimulation intensity will be set to ~50-60% of 1RM based on the subject's tolerance. The subject's tolerance gradually increases, and electrical stimulation intensity is reset every 2 weeks.

Hybrid Training System (HTS)

Sensory TENS while walking at a comfortable pace for 30 minutes.
Sensory TENS: The electrical stimulation intensity will be set under the muscle contraction threshold (but at a level at which the subject can perceive as sensory TENS). Electrical stimulation parameters (i.e. waveform and pulse duration) will be the same of HTS, while the amplitude will be lower. The subject will be stimulated using the same device as for HTS.

Transcutaneous Electrical Nerve Stimulation (TENS)

Total

Sex: Female, Male

Race and Ethnicity Not Collected

Digital physicians scale (Detecto 6449 Digital Physician Scale, DETECTO Scale Company, Webb City, MO).

Weight

Wall mounted stadiometer (seca 216 Stadiometer, seca Corporation, Chino, CA)

Height

BMI was calculated by dividing body mass by the square of the height.

Body Mass Index (BMI)

20-Meter Walk Time

5-Chair Stand Time

Stair Climb Time

Maximum isokinetic torque measured on the HUMAC NORM (Model 502140, Computer Sports Medicine, Inc., Stoughton, MA).

Knee Extension Torque

Knee Flexion Torque

The Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain subscale was used at baseline and follow-up to assess participant outcomes. The pain subscale is made up of 9 questions and was scored from zero to 100, with zero corresponding to extreme knee problems and 100 corresponding to no knee problems.

Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain Subscale

The Knee Injury and Osteoarthritis Outcome Score (KOOS) Quality of Life (QOL) subscale was used at baseline and follow-up to assess participant outcomes. The QOL subscale is made up of 4 questions and was scored from zero to 100, with zero corresponding to extreme knee problems and 100 corresponding to no knee problems.

Knee Injury and Osteoarthritis Outcome Score (KOOS) Quality of Life (QOL) sub scale

Knee pain will be evaluated using a visual analog scale (VAS) of 100 mm from no pain (0 mm) to the worst imaginable pain (100 mm). Participants will be asked to record their pain levels of the one week prior to their baseline visit.

Knee Pain by Visual Analog Scale

Participants will be familiarized with strength testing equipment and counseled on proper lifting technique. They will undergo testing to determine their peak isokinetic knee extensor torque, using an isokinetic dynamometer.

Change in Knee Extensor Strength Assessed by Isokinetic Dynamometer.

Participants will be familiarized with strength testing equipment and counseled on proper lifting technique. They will undergo testing to determine their peak isokinetic knee flexor torque, using an isokinetic dynamometer.

Change in Knee Flexor Strength Assessed by Isokinetic Dynamometer

Knee pain will be evaluated using a visual analog scale (VAS) of 100 mm from no pain (0 mm) to the worst imaginable pain (100 mm). Participants will be asked to record their pain levels of the past one week.

Change in Knee Pain Assessed by a Visual Analog Scale (VAS)

Change in Knee Pain Assessed by Knee Injury and Osteoarthritis Outcome Score (KOOS)

Change in Quality of Life (QOL) Assessed by Knee Injury and Osteoarthritis Outcome Score (KOOS)

Average time of two trials used for each participant.

Change in 20-meter Walk Time.

Change in 5-chair Stand Time.

Change in Stair Climb Time.

Overall Study

Neil Segal

Knee Osteoarthritis

Electrodes (15 cm x 6 cm) will be placed over the quadriceps and electrodes (11 cm x 6 cm) (Sekisui Plastics Co., Tokyo, Japan) will be placed over the hamstrings. Electrical stimulation parameters will be based on a standard Russian waveform in which a 5,000 Hz carrier frequency is modulated at 40 Hz (2.4 ms on, 22.6 ms off) to deliver a rectangular voltage biphasic pulse. Acceleration sensors as a joint motion sensor (EWTS9PD, Home Appliances Development Center Corporate Engineering Division, Appliances Company Panasonic Corporation 2-3-1-2 Noji-higashi,Kusatsu City, Shiga, Japan) is placed on the front of each leg 88mm above the patellar edge. It analyzes the algorithm of each exercise pattern, and stimulates the antagonist of the motion of each bilateral knee joint during exercise. Electrical stimulation intensity will be set to ~50-60% of 1RM based on the subject's tolerance. The subject's tolerance gradually increases, and electrical stimulation intensity is reset every 2 weeks.

The electrical stimulation intensity will be set under the muscle contraction threshold (but at a level at which the subject can perceive as sensory TENS). Electrical stimulation parameters (i.e. waveform and pulse duration) will be the same of HTS, while the amplitude will be lower. The subject will be stimulated using the same device as for HTS.

Sensory TENS

University of Kansas Medical Center

Combined Application of Electrical Stimulated Antagonist Contraction During Walking (Walking Study)

Determining Efficacy of the Combined Application of Electrical Stimulated Antagonist Contraction During Walking With Sensory TENS for Increasing Strength and Decreasing Pain in Women With Frequent Knee Symptoms

huntington disease/otyłość

Isoleucine Intake and Intermediary Metabolism in Type 2 Diabetes

The Absorption of Bioactive Berberine in Human

Combined Application of Electrical Stimulated Antagonist Contraction During Walking (Walking Study)

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