- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT04953936
β-hydroxy-β-methylbutyrate-enriched Nutritional Supplements for Obesity Adults
13 september 2021 uppdaterad av: Yuxiang Liang, West China Hospital
β-hydroxy-β-methylbutyrate-enriched Nutritional Supplements for Obesity Adults During Weight Loss: a Randomized Double-blind Placebo-controlled Clinical Trial
The purpose of this study is to assess the effectiveness and safety of HMB-enriched nutritional supplements for improving muscle mass and muscle function in Chinese adults with obesity during the weight loss process using calorie restriction.
Studieöversikt
Status
Har inte rekryterat ännu
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Förväntat)
72
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Yuxaing Liang
- Telefonnummer: 0086-13982250862
- E-post: yx45liang@sina.com
Studieorter
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Sichuan
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Chengdu, Sichuan, Kina, 610064
- West China Hospital,Sichuan University
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
30 år till 50 år (Vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
Inclusion Criteria:
- Men and women aged 30-50 years
- Currently having obesity defined by body mass index (BMI) ≥ 28 kg/m2 (based on measured body weight and height at booking, using validated scales)
- Having an intention to lost weight via caloric restriction
- Apparently healthy and able to walk independently
- Able to eat independently to meet their energy needs
- Without significant body weight change in the last 6 month (less than 5% change in body weight)
- Having sedentary habit defined by Sedentary Behavior Research Network
- Able to collaborate with the research staff.
Exclusion Criteria:
- Having a history of intolerance to enteral nutrition, food (e.g., lactose intolerance), or being allergic to the components of our HMB-enriched nutritional supplements (e.g., soy or corn);
- Having any implants (e.g., pacemakers);
- Current use of other nutritional supplements or drugs that may have an impact on the effectiveness of the intervention (e.g., glucocorticoids, antineoplastic drugs, antituberculosis drugs, sedatives, antipsychotics, muscle relaxants, monoamine oxidase inhibitors, antibiotics) within 3 months prior to enrollment;
- Secondary obesity caused by diseases (e.g., hypothalamic diseases and hypercortisolism) or drugs (e.g. glucocorticoids, insulin, tricyclic antidepressants);
- Clinically visible edema;
- Trauma, surgery, hospitalization, fall, or fracture within 6 months prior to enrollment;
- Pregnancy, having pregnancy plans, or lactation;
- Individuals who are participating in other clinical trials; any acute illness (e.g., acute infection, myocardial infarction, arrhythmia, myocarditis, appendicitis, etc.);
- Swallowing disorders; abnormal thyroid function (including hyperthyroidism and hypothyroidism);
- Having a history of diabetes, respiratory diseases, cardiovascular diseases, uncontrolled hypertension, kidney diseases, digestive system diseases, renal insufficiency, mental illness, neurological diseases, hematologic diseases, liver diseases (except for fatty liver), chronic infection (e.g., tuberculosis), immune system diseases, joint disorders, any type of tumor;
- Alcohol consumption over two standard alcoholic beverages (20 g of alcohol/day);
- Difficulty to comply with the study protocol;
- Other conditions that indicate the individuals are inappropriate for participation in this study.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: HMB
The participants will receive oral HMB-enriched nutritional supplements (65 g once daily)
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The participants will receive oral HMB-enriched nutritional supplements (65 g, once daily), which include soybean isolate protein, flaxseed oil powder, yam powder, whey protein, oligomeric isomaltose powder, cocoa powder, medium-chain fatty acid powder, calcium beta-hydroxy-beta-methylbutyrate, sunflower seed oil powder, L-glutamine, wheat germ powder, membrane isolated casein, wheat oligopeptide, konjac flour, vitamin E, vitamin D, stevioside, edible flavors.
Caloric restriction diet with individualized nutritional guidance from professional dietitians by video regarding caloric restriction strategies
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Placebo-jämförare: Placebo
The participants will receive a placebo (maltodextrin 65 g once daily) with the same package as the intervention.
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Caloric restriction diet with individualized nutritional guidance from professional dietitians by video regarding caloric restriction strategies
Placebo (maltodextrin 65 g once daily) with the same package as the intervention.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
The mean change in whole-body skeletal muscle mass (SMM)
Tidsram: 12 weeks
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The whole-body skeletal muscle mass (SMM)
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12 weeks
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
The mean change in appendicular skeletal muscle mass (ASMM)
Tidsram: 12 weeks
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These data will be measured using InBody 770 (Biospace Co., Seoul, Korea).
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12 weeks
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The mean change in trunk skeletal muscle mass (TSMM)
Tidsram: 12 weeks
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These data will be measured using InBody 770 (Biospace Co., Seoul, Korea).
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12 weeks
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The mean change in total body fat mass (BFM)
Tidsram: 12 weeks
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These data will be measured using InBody 770 (Biospace Co., Seoul, Korea).
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12 weeks
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The mean change in total appendicular body fat mass (ABFM)
Tidsram: 12 weeks
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These data will be measured using InBody 770 (Biospace Co., Seoul, Korea).
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12 weeks
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The mean change in trunk body fat mass (TBFM)
Tidsram: 12 weeks
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These data will be measured using InBody 770 (Biospace Co., Seoul, Korea).
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12 weeks
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The mean change in basal metabolic rate (BMR)
Tidsram: 12 weeks
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These data will be measured using InBody 770 (Biospace Co., Seoul, Korea).
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12 weeks
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The mean change in phase angle (PA)
Tidsram: 12 weeks
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These data will be measured using InBody 770 (Biospace Co., Seoul, Korea).
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12 weeks
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The mean change in body weight (BW)
Tidsram: 12 weeks
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These data will be measured using InBody 770 (Biospace Co., Seoul, Korea).
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12 weeks
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The mean change in handgrip strength (HGS)
Tidsram: 6 and 12 weeks
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A trained nurse will measure HGS using a digital handheld dynamometer (EH101; Xiangshan Inc, Guangdong, China) to the nearest 0.1 kg .
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6 and 12 weeks
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The mean change in waist circumference
Tidsram: 6 and 12 weeks
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A trained nurse will measure waist circumference using a tape at the level midway between the lower rib margin and the iliac crest with the participant breathing out gently.
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6 and 12 weeks
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The mean change in hip circumference
Tidsram: 6 and 12 weeks
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Hip circumference was measured as the maximum circumference over the buttocks
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6 and 12 weeks
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The mean change in physical activity
Tidsram: From the beginning to weeks 3, 6, 9, and 12.
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It will be measured using self-reported International Physical Activity Questionnaire Short Form (IPAQ-SF).The International Physical Activity Questionnaires (IPAQ) comprises a set of 4 questionnaires.
Long (5 activity domains asked independently) and short (4 generic items) versions for use by either telephone or self-administered methods are available.
The purpose of the questionnaires is to provide common instruments that can be used to obtain internationally comparable data on health related physical activity.
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From the beginning to weeks 3, 6, 9, and 12.
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The mean change in the score of the sit-to-stand test
Tidsram: 6 and 12 weeks
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A trained nurse will perform the 30-second sit-to-stand test ,which is a classic test for measuring the performance of lower extremity muscles.
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6 and 12 weeks
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The mean change in energy intake
Tidsram: From the beginning to weeks 3, 6, 9, and 12
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It will be measured for all participants using the self-reported Food Frequency Questionnaire (FFQ)
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From the beginning to weeks 3, 6, 9, and 12
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The mean change in lipid profiles
Tidsram: 12 weeks
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It will be tested using standard method.
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12 weeks
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The mean change in fasting glucose
Tidsram: 12 weeks
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It will be tested using standard method.
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12 weeks
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The mean change in fasting insulin
Tidsram: 12 weeks
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It will be tested using standard method.
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12 weeks
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The mean change in HOMA-IR
Tidsram: 12 weeks
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It will be tested using standard method.
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12 weeks
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The mean change in albumin
Tidsram: 12 weeks
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It will be tested using standard method.
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12 weeks
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Studierektor: Jiaojiao Jiang, West China Hospital
- Studiestol: Ming Yang, West China Hospital
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Förväntat)
20 september 2021
Primärt slutförande (Förväntat)
31 oktober 2021
Avslutad studie (Förväntat)
31 december 2021
Studieregistreringsdatum
Först inskickad
12 juni 2021
Först inskickad som uppfyllde QC-kriterierna
28 juni 2021
Första postat (Faktisk)
8 juli 2021
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
14 september 2021
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
13 september 2021
Senast verifierad
1 september 2021
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 2021(202)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
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