Development and Pragmatic Randomized Controlled Trial of Healthy Ketogenic Diet Versus Energy-Restricted Diet on Weight Loss in Adults with Obesity.

Publisher: MDPI Publishing Country of Publication: Switzerland NLM ID: 101521595 Publication Model: Electronic Cited Medium: Internet ISSN: 2072-6643 (Electronic) Linking ISSN: 20726643 NLM ISO Abbreviation: Nutrients Subsets: MEDLINE

Original Publication: Basel, Switzerland : MDPI Publishing

Caloric Restriction*/methods ; Diet, Ketogenic*/methods ; Diet, Reducing*/methods ; Obesity*/diet therapy ; Weight Loss*; Adult ; Female ; Humans ; Male ; Middle Aged ; Body Mass Index ; Treatment Outcome

Introduction : The ketogenic diet (KD) is widely used for weight management by reducing appetite, enhancing fat oxidation, and facilitating weight loss. However, the high content of total and saturated fats in a conventional KD may elevate low-density lipoprotein (LDL)-cholesterol levels, a known risk factor for cardiovascular diseases, highlighting the need for healthier alternatives. This study aimed to investigate the effect of a newly developed Healthy Ketogenic Diet (HKD) versus an Energy-Restricted Diet (ERD) on weight loss and metabolic outcomes among adults with obesity. Methods : Multi-ethnic Asian adults ( n = 80) with body mass index ≥ 27.5 kg/m ² were randomized either to HKD ( n = 41) or ERD (n = 39) for 6 months. Both groups followed an energy-restricted healthy diet, emphasizing on reducing saturated and trans fats. The HKD group additionally limited net carbohydrate intake to no more than 50 g per day. Dietary adherence was supported via the Nutritionist Buddy app with dietitian coaching. The primary outcome was weight change from baseline at 6 months. Secondary outcomes included weight change at 3 months and 1 year, along with changes in metabolic profiles. Data were analyzed using linear regression with an intention-to-treat approach. Results : The HKD group achieved significantly greater mean weight loss at 6 months than the ERD group (-7.8 ± 5.2 kg vs. -4.2 ± 5.6 kg, p = 0.01). The mean weight loss percentage at 6 months was 9.3 ± 5.9% and 4.9 ± 5.8% for the HKD and ERD groups, respectively ( p = 0.004). Improvements in metabolic profiles were also significantly better in the HKD group [glycated hemoglobin (-0.3 ± 0.3% vs. -0.1 ± 0.2%, p = 0.008), systolic blood pressure (-7.7 ± 8.9 mmHg vs. -2.6 ± 12.2 mmHg, p = 0.005), and aspartate transaminase (-7.6 ± 15.5 IU/L vs. 0.6 ± 11.5 IU/L, p = 0.01)], with no increase in LDL-cholesterol (-0.12 ± 0.60 mmol/L vs. -0.04 ± 0.56 mmol/L, p = 0.97) observed in either group. Conclusions : The HKD was more effective than the ERD in promoting weight loss and improving cardiometabolic outcomes without elevation in LDL-cholesterol. It can be recommended for therapeutic intervention in patients with obesity.

Br J Nutr. 2013 Oct;110(7):1178-87. (PMID: 23651522)
JAMA Netw Open. 2021 Jun 1;4(6):e2112417. (PMID: 34081137)
N Engl J Med. 2008 Jul 17;359(3):229-41. (PMID: 18635428)
Eur J Clin Nutr. 2013 Jul;67(7):759-64. (PMID: 23632752)
Nutr Rev. 2019 Mar 1;77(3):161-180. (PMID: 30544168)
Diabetologia. 2001 Mar;44(3):312-9. (PMID: 11317662)
Front Nutr. 2021 Jul 16;8:702802. (PMID: 34336911)
Nutr Diabetes. 2023 Sep 14;13(1):16. (PMID: 37709770)
Nutr Metab (Lond). 2016 Dec 9;13:92. (PMID: 27990172)
Hum Nutr Clin Nutr. 1985;39 Suppl 1:5-41. (PMID: 4044297)
Int J Obes (Lond). 2017 Aug;41(8):1224-1231. (PMID: 28439092)
Obesity (Silver Spring). 2021 Oct;29(10):1606-1614. (PMID: 34124856)
Front Nutr. 2022 Jan 24;8:780567. (PMID: 35141265)
Br J Nutr. 2016 Feb 14;115(3):466-79. (PMID: 26768850)
JMIR Mhealth Uhealth. 2020 Apr 13;8(4):e14802. (PMID: 32281943)
Perspect Psychol Sci. 2017 Sep;12(5):703-714. (PMID: 28657838)
BMC Med. 2022 Apr 22;20(1):139. (PMID: 35449060)
Int J Vitam Nutr Res. 2011 Mar;81(2-3):101-7. (PMID: 22139560)
Nat Med. 2021 Feb;27(2):344-353. (PMID: 33479499)
Nutrients. 2020 Oct 21;12(10):. (PMID: 33096647)
Cureus. 2020 Aug 10;12(8):e9639. (PMID: 32923239)
J Clin Lipidol. 2019 Sep - Oct;13(5):689-711.e1. (PMID: 31611148)
Nutrients. 2021 Mar 02;13(3):. (PMID: 33801247)
Int J Environ Res Public Health. 2022 Aug 22;19(16):. (PMID: 36012064)
Nutr Res. 2019 Feb;62:64-77. (PMID: 30803508)
J Diabetes Investig. 2018 Sep;9(5):1135-1143. (PMID: 29328544)
Obesity (Silver Spring). 2020 Dec;28(12):2331-2338. (PMID: 33230962)
Gut Microbes. 2017 Mar 4;8(2):172-184. (PMID: 28165863)
Curr Opin Endocrinol Diabetes Obes. 2021 Oct 1;28(5):463-468. (PMID: 34468401)
Obes Facts. 2021;14(2):222-245. (PMID: 33882506)
Lancet Diabetes Endocrinol. 2021 Jul;9(7):419-426. (PMID: 33989535)

(NMRC/HSRG/0063/2016) Singapore Ministry of Health's National Medical Research Council under its Health Services Research Grant

Keywords: Asian; adults; energy-restricted diet; healthy ketogenic diet; metabolic outcomes; obesity; weight loss

Date Created: 20250108 Date Completed: 20250108 Latest Revision: 20250115

20250115

PMC11677078

10.3390/nu16244380

39771001