- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT05384106
AN OPEN-LABEL, ACUTE CLINICAL TRIAL TO ASSESS THE LEVEL OF KETONE PRODUCTION FOLLOWING CONSUMPTION OF AVELA™ (R)-1,3-BUTANEDIOL IN AN ADULT POPULATION
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
Primary:
To evaluate the level of production of BHB following the consumption of 3 servings of Avela™, with consumption of each serving separated by 30 minutes and each serving providing 11.5 g of (R)-1,3-butanediol [total intake of 34.5 g of (R)-1,3-butanediol].
BHB levels will be measured using capillary whole blood from the fingertips using at home Keto-Mojo monitoring system (β-Ketone, as beta-hydroxybutyrate, in fingertip capillary whole blood).
Measurement Range: 0.1 - 8.0 mmol/L Measurement time (min): 0, 30, 60, 90, 120, 180, 240, 300
Secondary:
To evaluate the acute effects of 3 servings of Avela™, with consumption of each serving separated by 30 minutes and each serving providing 11.5 g of (R)-1,3-butanediol [i.e., total intake of 34.5 g (R)-1,3-butanediol] on: GI tolerance.
All subjects will complete the mVAS GI symptoms tool at baseline (0 minutes), and at 30, 60, 90, 120, 180, 240, and 300 minutes.
A validated tool to measure GI tolerability of (R)-1,3-butanediol will be utilized. The mVAS GI symptoms tool is a self-administered questionnaire, which is modeled after the validated "gold standard" measurement tool predominantly used to test clinical gastroenterology scenarios (Bengtsson et al., 2013).
Sleepiness/alertness The SSS (Shahid et al., 2012) is a subjective tool to assess how alert a subject is feeling at specific moments in time. The scale requires respondents to select a rating of 1 to 7, where a "1" indicates the subject is "feeling active, vital, alert, or wide awake" and the highest score of "7" indicates the subject is "no longer fighting sleep, sleep onset soon; having dream-like thoughts" (Hoddes et al., 1973). The scale is validated, correlating r = 0.68 with performance on the Wilkinson tests. All subjects will complete the SSS at baseline (0 minutes) and at 30, 60, 90, 120, 180, 240, and 300 minutes.
Studietyp
Inskrivning (Förväntat)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: James Lowder, MD
- Telefonnummer: 619-387-7120
- E-post: research@impactsciencealliance.org
Studera Kontakt Backup
- Namn: Vassili Kotlov
- Telefonnummer: 619-387-7120
- E-post: research@impactsciencealliance.org
Studieorter
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California
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San Diego, California, Förenta staterna, 92106
- Moniker Commons
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Kontakt:
- Vassili Kotlov
- E-post: research@impactsciencealliance.org
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- Males and females, 18 to 65 years of age
- BMI 18 to <35.0 kg/m2, inclusive
- Weight ≥ 110 lbs
- Subject is judged to be in good health on the basis of medical history
- Subject is willing to fast for 12 hours prior to study start
- Subject is willing to avoid alcohol and intense physical activity the day prior to and on the day of testing
- Subject is capable of giving informed consent and complying with all study procedures/requirements.
Exclusion Criteria:
- Previous GI disorders (e.g., inflammatory bowel disease, irritable bowel syndrome, history of surgery for weight loss, or gastroparesis)
- Gastroenteritis in the 2 weeks preceding the study
- Diabetes
- Weight <110 lbs
- History of alcohol or drug abuse
- Previous diagnosis of neurological disorders, depression, or mental illness with psychosis
- Unexplained alarm features (i.e., unintentional weight loss >10% body weight in the last 3 months, fevers, or blood in stools)
- Use of an antibiotic or any medication impacting gut transit during the 2 weeks before the study
- Constipation or diarrhea (defined as, on average, less than 3 stools per week or more than 3 stools per day, respectively)
- Allergy to tree nuts
- Women who are pregnant or breastfeeding
- Persons with medical conditions affecting the pancreas, liver, thyroid, or gall bladder.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Övrig
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: Avela™ (R)-1,3-Butanediol
3 servings of Avela™, with consumption of each serving separated by 30 minutes and each serving providing 11.5 g of (R)-1,3-butanediol [total intake of 34.5 g of (R)-1,3-butanediol].
|
Avela™ (R)-1,3-butanediol is intended to induce ketosis in the general adult population.
Avela™ (R)-1,3-butanediol is GRAS for use in beverages, bars, and gels
Andra namn:
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
To evaluate the level of production of BHB measure of blood ketones levels (i.e., blood BHB levels)
Tidsram: 0, 30, 60, 90, 120, 180, 240, and 300 minutes
|
β-Ketone, as beta-hydroxybutyrate, in fingertip capillary whole blood, Measurement Range: 0.1 - 8.0 mmol/L
|
0, 30, 60, 90, 120, 180, 240, and 300 minutes
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
To assess GI symptomology
Tidsram: 0, 30, 60, 90, 120, 180, 240, and 300 minutes
|
Modified visual analogue scale (mVAS) GI symptoms tool
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0, 30, 60, 90, 120, 180, 240, and 300 minutes
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To assess Sleepiness/alertness
Tidsram: 0, 30, 60, 90, 120, 180, 240, and 300 minutes
|
Stanford Sleepiness Scale (SSS)
|
0, 30, 60, 90, 120, 180, 240, and 300 minutes
|
Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart (Förväntat)
Primärt slutförande (Förväntat)
Avslutad studie (Förväntat)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- 1129
Plan för individuella deltagardata (IPD)
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Läkemedels- och apparatinformation, studiedokument
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